Welcome to our Clinical Trials Resources page connecting the ATS community to current, ongoing clinical trials in pulmonary, critical care, and sleep medicine being conducted by participating pharmaceutical and device companies. The ATS does not endorse any trial listed. However, we hope the below trial opportunities will be a valuable resource to clinicians, patients, and researchers in the combined goal of improving and advancing patient care. A complete U.S. Clinical Trial listing can be found at http://clinicaltrials.gov/.
Companies that are ATS Corporate Members at the Supporter Level or higher can list clinical trials at no charge as part of member benefits. If your company is not a current ATS Corporate Member and you would like to see your company’s trials listed, please contact Vlada Kagan O'Hara.
Trials in Asthma
Trials in COPD
- AERIFY1
- AERIFY2
- AERIFY3
- ARNASA
- INSIGNIA PH-COPD
- LIBERTY COPD NOTUS
- OBERON
- PILLAR
- RESOLUTE
- SUSPIRE-1
- TITANIA
- TRITON
Trials in COVID-19
Trials in HES
Trials in Idiopathic Pulmonary Fibrosis (IPF)
Trials in Interstitial Lung Disease (ILD)
Trials in Lung Infection
Trials in NTM
Trials in PPF
Trials in Pulmonary Arterial Hypertension (PAH)
Trials in Pulmonary Hypertension associated with Interstitial Lung Disease (PH-ILD)
Trials in Pulmonary Hypertension (PH)
ADVANCE OUTCOMES
Company:
United Therapeutics Corporation
Clinical Trial Title:
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Ralinepag When Added to PAH Standard of Care or PAH Specific Background Therapy in Subjects With WHO Group 1 PAH (ADVANCE OUTCOMES)
Clinical Trial Description:
This is a multicenter, randomized, double-blind, placebo-controlled study. Subjects who meet entry criteria will be randomly allocated 1:1 to receive ralinepag or placebo, in addition to their standard of care or PAH-specific background therapy, as applicable. The primary endpoint is the time (in days) from randomization to the first adjudicated protocol-defined clinical worsening event. All primary endpoint events will be adjudicated by an independent Clinical Event Committee (CEC) in a blinded fashion. Subjects who have a confirmed primary endpoint event adjudicated by the CEC at any time during the study and all subjects on treatment at the conclusion of the study who have completed the Week 28 Visit (after the target number of confirmed events is achieved) will have the option to enroll in an open-label extension (OLE) study. Subjects who do not choose to participate in the OLE study will discontinue study drug and should remain in the study for long-term follow-up of survival status and will receive standard of care PAH treatment, at the discretion of the treating physician.
Eligible Patients:
Primary diagnosis of symptomatic PAH who have WHO/ NYHA functional class II to IV symptoms. At least 18 years of age.
Visit the study’s ClinicalTrials.gov page using the link below to view the full eligibility criteria.
Contact:
United Therapeutics Global Medical Information
Phone Number: 919-485-8350
Email: clinicaltrials@unither.com
Date Posted:
June 27, 2024
Learn more about this clinical trial
AERIFY1
Company:
Sanofi and Regeneron
Clinical Trial Title:
Randomized, double-blind, placebo-controlled, parallel-group Phase 3 study to evaluate the efficacy, safety, and tolerability of SAR440340/REGN3500/itepekimab (anti-IL-33 mAb) in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) Study # EFC16750
Clinical Trial Description:
EFC16750 is a clinical research study for former smoker patients with moderate to very severe chronic obstructive pulmonary disease (COPD), to evaluate an injectable investigational study drug. The study will enroll approximately 186 patients with COPD in at approximately 47 study centers throughout the United States.
Eligible Patients:
This clinical research study is for adults aged 40-85 years old who have experienced moderate to severe exacerbations of COPD in the last year.
Contact:
A Clinical Trials Contact What is COPD | AERIFY COPD Clinical Study | Sanofi Studies
Date Posted:
April 11, 2022
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AERIFY2
Company:
Sanofi and Regeneron
Clinical Trial Title:
Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD) (AERIFY-2)
Clinical Trial Description:
Sanofi and Regeneron are researching if an investigational medicine plus certain controller therapies could potentially lessen COPD symptoms and improve breathing and overall well-being in former smokers (>10 packs year) who are between 40 and 85 years old with moderate-to-severe COPD. This global, multi-center, phase 3 clinical trial (AERIFY 2) is a randomized, double-blind, placebo-controlled, parallel-group Phase 3 study to evaluate the efficacy, safety, and tolerability of SAR440340/ REGN3500/ Itepekimab (Anti-IL-33 mAb) in former smokers with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD). The study expects to enroll 1,210 participants across 254 sites.
Eligible Patients:
Former smokers, ages 40-85, with moderate-to-severe COPD
Contact:
Sanofi Trial Transparency
800-633-1610, option 6
Contact-US@sanofi.com
Date Posted:
July 10, 2023
Learn more about this clinical trial
AERIFY3
Company:
Sanofi and Regeneron
Clinical Trial Title:
A Phase 2 Mechanistic Study of the Effect of Itepekimab on Airway Inflammation in Patients with COPD (AERIFY-3)
Clinical Trial Description:
Treatments for chronic obstructive pulmonary disease (COPD) may still leave you looking for relief from wheezing, coughing, and shortness of breath. That’s why Sanofi and Regeneron are researching the mechanism of action of an investigational medicine in former and current smokers who are between 40 and 70 years old with COPD.
This phase 2a clinical trial (AERIFY 3) is an exploratory, two-part, 12-week study to evaluate the mechanism of action of itepekimab (Anti-IL-33 mAb) and its impact on airway inflammation. This study consists of participants who have been on a standard-of-care (SoC) mono (long-acting β2-agonist [LABA]) or long-acting muscarinic antagonist [LAMA]), double (inhaled corticosteroid [ICS] + LABA, LABA + LAMA or ICS + LAMA), or triple (ICS + LABA + LAMA) controller therapy for COPD for at least 3 months prior to Screening (Visit 1) with stable dose and regimen for controller therapy for ≥1 month prior to Screening (Visit 1) and during the screening period. Participants will stay on their established controller medications for COPD throughout the duration of the study, with the exception of systemic corticosteroids and/or antibiotics used for acute exacerbation of COPD (AECOPD). The study expects to enroll 60 participants.
Eligible Patients:
Former and current smokers, between 40-70 years old, with COPD
Contact:
Sanofi Trial Transparency
800-633-1610, option 6
Contact-US@sanofi.com
Date Posted:
July 10, 2023
Learn more about this clinical trial
ALOFT - IPF
Company:
Bristol Myers Squibb
Clinical Trial Title:
The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in participants with Idiopathic Pulmonary Fibrosis.
Clinical Trial Description:
The ALOFT-IPF Study is a multicenter, randomized, double-blind, placebo-controlled, phase 3 study to evaluate the efficacy, safety, and tolerability of BMS-986278 in participants with Idiopathic Pulmonary Fibrosis. (IM027-068).
Eligible Patients:
Adults aged 40 years and older with a diagnosis of IPF within 7 years prior to screening.
Contact:
Name: BMS Study Connect Contact Center
www.BMSStudyConnect.com
Phone Number (US): 855-907-3286
Email: Clinical.Trials@bms.com
Date Posted:
March 21, 2024
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ALOFT - PPF
Company:
Bristol Myers Squibb
Clinical Trial Title:
The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in Participants with Progressive Pulmonary Fibrosis.
Clinical Trial Description:
The ALOFT-PPF Study is a multicenter, randomized, double-blind, placebo-controlled, phase 3 study to evaluate the efficacy, safety, and tolerability of BMS-986278 in participants with Progressive Pulmonary Fibrosis. (IM027-1015).
Eligible Patients:
Adults aged 21 years and older with a diagnosis of interstitial lung disease (ILD) with features consistent with progressive ILD within 24 months prior to screening, and ≥ 10% extent of fibrosis on screening high-resolution computed tomography (HRCT).
Contact:
Name: BMS Study Connect Contact Center
www.BMSStudyConnect.com
Phone Number (US): 855-907-3286
Email: Clinical.Trials@bms.com
Date Posted:
March 21, 2024
Learn more about this clinical trial
ARISE and ENCORE
Company:
Insmed Incorporated
Clinical Trial Titles:
ARISE - A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Multicenter Study to Validate Patient-Reported Outcome Instruments in Adult Subjects With Newly Diagnosed Nontuberculous Mycobacterial (NTM) Lung Infection Caused by Mycobacterium Avium Complex (MAC)
ENCORE - A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Multicenter Study to Evaluate the Efficacy and Safety of an Amikacin Liposome Inhalation Suspension (ALIS)-Based Regimen in Adult Subjects With Newly Diagnosed Nontuberculous Mycobacterial (NTM) Lung Infection Caused by Mycobacterium Avium Complex (MAC)
Clinical Trial Description:
ARISE and ENCORE are parallel clinical research studies for adults with a recent diagnosis of Mycobacterial avium complex (MAC) lung infection to evaluate an inhaled investigational study drug (amikacin liposome inhalation suspension). Eligible patients will be assigned to one of these two studies that together will enroll approximately 350 individuals with MAC lung infection in at approximately 150 study centers globally.
Eligible Patients:
These clinical research studies are for adults age 18 and older with a current diagnosis of Mycobacterium avium Complex (MAC) lung infection.
Contacts:
Insmed Medical Information
844-4-INSMED
medicalinformation@insmed.com
Date Posted:
June 7, 2021
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ARNASA
Company:
Genentech/Roche
Clinical Trial Titles:
ARNASA
Clinical Trial Description:
This Phase 3 study will evaluate the efficacy and safety of astegolimab compared with placebo in patients with moderate to severe chronic obstructive pulmonary disease (COPD), who are former or current smokers, have experienced ≥ 2 exacerbations within the last 12 months and independent of eosinophil counts.
Eligible Patients:
This clinical research study is for adults age 40 – 80 years.
Contacts:
https://forpatients.roche.com or 888-662-6728
Reference Study ID Number: GB44332
Date Posted:
July 10, 2023
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ARTISAN
Company:
United Therapeutics Corporation
Clinical Trial Titles:
A Phase 4, Prospective, Multicenter, Single-Arm Study of a Mean Pulmonary Artery Pressure-Targeted Approach With Early and Rapid Treprostinil Therapy to Reverse Right Ventricular Remodeling in Patients With Pulmonary Arterial Hypertension: ARTISAN (Afterload Reduction To Improve Right Ventricular Structure And Function)
Clinical Trial Description:
The primary objective of this study is to assess the effect of early and rapid treprostinil therapy for mean pulmonary artery pressure (mPAP) reduction, monitored by a CardioMEMS implant and to measure improvement in right ventricular (RV) function and reverse RV remodeling using cardiac MRI.
Eligible Patients:
PAH patients within 6 months of diagnosis, REVEAL Lite 2 risk score ≤9, WHO FC II or III, and 6MWD >165 meters. Visit the study’s ClinicalTrials.gov page using the link below to view the full eligibility criteria.
Contacts:
United Therapeutics Global Medical Information
Phone Number: 919-485-8350
Email: clinicaltrials@unither.com
Date Posted:
June 27, 2024
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ATHENA SSc-ILD
Company:
Prometheus Biosciences Inc., a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
Clinical Trial Title:
A Double Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-7240/PRA023 in Subjects with Systemic Sclerosis Associated with Interstitial Lung Disease (SSc-ILD)
Efficacy and Safety of Tozorakimab (MEDI3506) in Symptomatic Chronic Obstructive Pulmonary Disease with a History of Exacerbations.
Clinical Trial Description:
ATHENA SSc-ILD is a clinical research study for adults with systemic sclerosis with Interstitial Lung Disease (SSc-ILD) to evaluate the safety and efficacy of the investigational study drug via infusion. The study will enroll approximately 152 individuals with SSc-ILD in at approximately 80 study centers globally, 23 of which are located throughout the United States and Canada.
Eligible Patients:
This clinical research study is for adults age 18 and older.
Contacts:
Email - Clinicaltrials@prometheusbiosciences.com, Telephone: 858-422-4300
Date Posted:
August 5, 2024
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ATLAS
Company:
Sanofi and Regeneron
Clinical Trial Title:
A Phase 3b/4 Study Assessing the Long-term Effect of Dupilumab on Prevention of Lung Function Decline in Adult Patients With Uncontrolled Moderate to Severe Asthma
Clinical Trial Description:
Sanofi and Regeneron are studying the long-term effect of dupliumab on the prevention of lung function decline in adult patients with uncontrolled moderate to severe asthma. This Phase 3b/4 study (ATLAS), is an interventional, randomized, parallel group, treatment, double blind, 2-arm study to assess the effect of dupilumab compared to standard of care therapy on preventing or slowing the rate of lung function decline in adult patients with uncontrolled moderate to severe asthma.
The estimated duration is 4±1 weeks of screening and run-in period, followed by a 3-year double blinded treatment period. There will be a post-treatment follow-up (FU) period up to 12 weeks.
The study expects to enroll approximately 1860 participants across 168 study sites worldwide.
Eligible Patients:
Adults, between 18-65, with asthma
Contacts:
Sanofi Trial Transparency
800-633-1610, option 6
Contact-US@sanofi.com
Date Posted:
July 10, 2023
Learn more about this clinical trial
BEACON-IPF
Company:
Pliant Therapeutics Inc
Clinical Trial Title:
A Randomized, Double-blind, Dose-ranging, Placebo-controlled Study to Evaluate the Efficacy and Safety of Bexotegrast (PLN-74809) for the Treatment of Idiopathic Pulmonary Fibrosis (BEACON-IPF)
Clinical Trial Description:
This is a randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the efficacy and safety of 2 doses of bexotegrast (PLN-74809) [160 and 320 mg] taken for 52 weeks by participants with IPF taking and not taking background therapy (ie, nintedanib or pirfenidone). The study will consist of an up to 28-day Screening Period, a 52-week Treatment Period, and a 14-day Safety Follow-up Period. Of note, participants who are not taking background therapy at study entry will be allowed to initiate it at any time during the study.
Eligible Patients:
This clinical research study is for adults age 40 and older with IPF diagnosis ≤ 7 years prior to screening.
Contacts:
Pliant Therapeutics Medical Monitor (clintrials@pliantrx.com)
Date Posted:
November 21, 2023
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DECIPHER-ILD
Company:
United Therapeutics Corporation
Clinical Trial Title:
DeciPHer-ILD: A Real-world Patient Registry in Group 3 Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
Clinical Trial Description:
The purpose of this study is to observe and capture demographic characteristics, treatment patterns, and clinical outcomes of interest for patients with PH-ILD to further clinical understanding of the epidemiological landscape and outcomes of the disease and treatment.
In this registry, patients will be enrolled into 1 of 3 cohorts. Cohort 1 will include approximately 500 patients who are not receiving inhaled treprostinil at time of study enrollment. Cohort 2 will include approximately 150 patients who are newly initiated on Tyvaso/Tyvaso DPI. Cohort 3 will include approximately 350 patients who have been receiving Tyvaso/Tyvaso DPI for >60 days.
As part of the registry, assessments will be completed for data collection in 6- or 12 month intervals, unless the data are already available via standard of care. This patient registry will follow patients for up to 5 years after enrollment.
Assessments include pulmonary function tests (PFTs) including diffusing capacity of the lungs for carbon monoxide (DLCO); high resolution computed tomography (HRCT); vital signs; 6-Minute Walk Test; blood draw for plasma N-terminal pro-BNP (NT-proBNP) concentration, genetics analysis, biomarker analysis; echocardiography; EuroQoL 5 Dimension 5 Level Questionnaire (EQ-5D-5L); King's Brief Interstitial Lung Disease Questionnaire (K-BILD); Living with Pulmonary Fibrosis Questionnaire (L-PF); Therapy Administration Questionnaire; healthcare resource utilization; current medications and rehabilitation; WHO functional class; transplant status; survival data; and RHC.
Eligible Patients:
Patients with a diagnosis of pulmonary hypertension associated with interstitial lung disease. This includes patients who are and aren't receiving inhaled treprostinil, excluding patients receiving Yutrepia™ at Baseline.
Visit the study’s CT.gov page using the link below to view the full eligibility criteria.
Contact:
United Therapeutics Global Medical Information
Phone Number: 919-485-8350
Email: clinicaltrials@unither.com
Date Posted:
June 27, 2024
Learn more about this clinical trial
EXHALE-2
Company:
Areteia Therapeutics
Clinical Trial Title:
A Study to Assess the Effect of Dexpramipexole in Adolescents and Adults with Severe Eosinophilic Asthma (EXHALE-2)
Clinical Trial Description:
The purpose of EXHALE-2 is to assess the efficacy and safety of the Dexpramipexole, an oral eosinophil lowering therapy, in participants ≥ 12 years of age with severe eosinophilic asthma (GINA steps 4 or 5). The primary endpoint of this study is the annualized rate of asthma exacerbations.
Eligible Patients:
Participants who are ≥ 12 years of age and have inadequately controlled severe asthma with an eosinophilic phenotype and a history of asthma exacerbations, may be a suitable candidate for this trial.
Contacts:
EXHALE-2 is a Global, multi-center study. If you’re interested in participating, please contact the Sponsor via the email below:
EXHALE Recruiting
Phone Number:
888-584-9281
Email: clinicaltrials@areteiatx.com
Date Posted:
12/22/2023
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EXHALE-3
Company:
Areteia Therapeutics
Clinical Trial Title:
A Study to Assess the Effect of Dexpramipexole in Adolescents and Adults with Severe Eosinophilic Asthma (EXHALE-3)
Clinical Trial Description:
The purpose of EXHALE-3 is to assess the efficacy and safety of the Dexpramipexole, an oral eosinophil lowering therapy, in participants ≥ 12 years of age with severe eosinophilic asthma (GINA steps 4 or 5). The primary endpoint of this study is the annualized rate of asthma exacerbations.
Eligible Patients:
Participants who are ≥ 12 years of age and have inadequately controlled severe asthma with an eosinophilic phenotype and a history of asthma exacerbations, may be a suitable candidate for this trial.
Contacts:
EXHALE-3 is a Global, multi-center study. If you’re interested in participating, please contact the Sponsor via the email below:
EXHALE Recruiting
Phone Number:
888-584-9281
Email: clinicaltrials@areteiatx.com
Date Posted:
12/22/2023
Learn more about this clinical trial
EXHALE-4
Company:
Areteia Therapeutics
Clinical Trial Title:
A Study to Assess the Effect of Dexpramipexole in Adolescents and Adults with moderate to severe Eosinophilic Asthma (EXHALE-4)
Clinical Trial Description:
The purpose of EXHALE-4 is to assess the efficacy and safety of Dexpramipexole, oral eosinophil lowering therapy, in participants ≥ 12 years of age with inadequately controlled moderate to severe eosinophilic asthma (GINA Step 3, 4, or 5). The primary endpoint of this study is change in lung function (FEV1) from baseline
Eligible Patients:
Participants who are ≥ 12 years of age and have inadequately controlled severe asthma with an eosinophilic phenotype and a history of asthma exacerbations, may be a suitable candidate for this trial.
Contacts:
EXHALE-4 is a Global, multi-center study. If you’re interested in participating, please contact the Sponsor via the email below:
EXHALE Recruiting
Phone Number:
888-584-9281
Email: clinicaltrials@areteiatx.com
Date Posted:
12/22/2023
Learn more about this clinical trial
FIBRONEER - ILD
Company:
Boehringer Ingelheim
Clinical Trial Title:
A Study to Find Out Whether BI 1015550 Improves Lung Function in People with Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs)
Clinical Trial Description:
This study is open to adults with Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs). People who have a form of PF-ILD other than Idiopathic Pulmonary Fibrosis (IPF) can join the study. If they already take nintedanib, they can continue treatment throughout the study.
The purpose of this study is to find out whether a medicine called BI 1015550 helps people with PF-ILD. Participants are put into 3 groups randomly, which means by chance. Participants in 2 groups take different doses of BI 1015550 as tablets twice a day. Participants in the placebo group take placebo tablets twice a day. Placebo tablets look like BI 1015550 tablets but do not contain any medicine.
Participants are in the study for up to two and a half years. During the first year, they visit the study site 10 times. Afterwards, they visit the study site every 3 months. The doctors regularly test participants' lung function. The results of the lung function tests are compared between the groups. The doctors also regularly check participants' health and take note of any unwanted effects.
Eligible Patients:
- Patients ≥18 years old at the time of signed informed consent.
- Diagnosis of progressive fibrosing ILD other than IPF (physician confirmed).
- Patients may be either:
- On a stable therapy with nintedanib for at least 12 weeks prior to Visit 1 and during screening and are planning to stay on this background treatment after randomization.
- Not on treatment with nintedanib for at least 8 weeks prior to Visit 1 and during the screening period (e.g. either Antifibrotic (AF)-treatment naïve or previously discontinued) and do not plan to start or re-start antifibrotic treatment.
Contact:
clintriage.rdg@boehringer-ingelheim.com (1-800-243-0127)
Date Posted:
04/5/2023
Learn more about this clinical trial
FIBRONEER - IPF
Company:
Boehringer Ingelheim
Clinical Trial Title:
A Study to Find Out Whether BI 1015550 Improves Lung Function in People with Idiopathic Pulmonary Fibrosis (IPF)
Clinical Trial Description:
This study is open to adults with a lung disease called Idiopathic Pulmonary Fibrosis (IPF). People can join the study if they are 40 years or older. If they already take nintedanib or pirfenidone for their IPF, they can continue treatment throughout the study. The purpose of this study is to find out whether a medicine called BI 1015550 helps people with IPF.
Participants are put into 3 groups randomly, which means by chance. Participants in 2 groups take different doses of BI 1015550 as tablets twice a day. Participants in the placebo group take placebo tablets twice a day. Placebo tablets look like BI 1015550 tablets but do not contain any medicine.
Participants are in the study for up to two and a half years. During the first year, they visit the study site 10 times. Afterwards, they visit the study site every 3 months. The doctors regularly test participants' lung function. The results of the lung function tests are compared between the groups. The doctors also regularly check participants' health and take note of any unwanted effects.
Eligible Patients:
- Patients ≥40 years old at the time of signed informed consent.
- Diagnosis of Idiopathic Pulmonary Fibrosis (IPF)
- Patients may be either:
- On a stable therapy with nintedanib or pirfenidone for at least 12 weeks prior to Visit 1 and during screening and are planning to stay on this background treatment after randomization.
- Not on a treatment with nintedanib or pirfenidone for at least 8 weeks prior to Visit 1 and during the screening period (e.g. either Antifibrotic (AF)-treatment naïve or previously discontinued) and do not plan to start or re-start antifibrotic treatment.
Contact:
clintriage.rdg@boehringer-ingelheim.com (1-800-243-0127)
Date Posted:
04/5/2023
Learn more about this clinical trial
ICoN-1study.com
Company:
MannKind
Clinical Trial Title:
ICoN-1 (Inhaled Clofazimine for NTM)
Clinical Trial Description:
Research study that aims to evaluate the safety and efficacy of Clofazimine Inhalation Suspension in adults with Nontuberculous Mycobacteria (NTM). The study will enroll over 230 participants in about 100 centers across the United States, Japan, South Korea, Taiwan and Australia.
Eligible Patients:
This study is for adults who are 18 to 85 years of age with NTM. Participants must be taking more than one guideline-based therapy (GBT) medication for at least 6 months. Eligible participants also require positive mycobacterium avium complex (MAC) sputum cultures within the last 3 and 12 months.
Contacts:
For more information on ICON-1
Date Posted:
August 5, 2024
Learn more about this clinical trial
INSIGNIA PH-COPD
Company:
Merck Sharp & Dohme LLC
Clinical Trial Title:
A Phase 2a Randomized, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of MK-5475 in Adults With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Clinical Trial Description:
The purpose of this study is to evaluate the safety and efficacy of once daily oral inhalation dose of MK-5475 380µg in participants 40 to 85 years (inclusive) with Pulmonary Hypertension associated with Chronic Obstructive Pulmonary Disease (PH-COPD). The primary hypothesis of the study is MK-5475, a soluble Guanylate Cyclase (sGC) stimulator is superior to placebo in increasing 6 Minute Walking Distance (6MWD) from baseline at Week 24.
Eligible Patients:
This clinical research study is for adults ages 40 - 85.
Contacts:
1-888-577-8839 or Trialsites@merck.com
Date Posted:
September 5, 2023
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LIBERTY COPD NOTUS
Company:
Sanofi
Clinical Trial Title:
Liberty Notus: Safety & Efficacy of dupilumab in moderate to severe COPD patients
Clinical Trial Description:
Study EFC15805, also called NOTUS, is a Phase 3 clinical research studies for people aged 40-85 who have moderate to severe chronic obstructive pulmonary disease (COPD) and are currently being treated with standard of care therapy. The study will evaluate whether the study medication can reduce the rate of moderate to severe acute exacerbations of COPD; improve the way patients feel; improve their level of activity; improve their breathing, which may potentially reduce the need for rescue or reliever medications.
During the study, participants will receive either dupilumab or placebo as an injection once every 2 weeks for a year. All study-related medical care for their COPD as well as their standard of care COPD medication will be covered by the sponsor, Sanofi, at no cost to the study participant.
Compensation for time and travel may also be available for study participants.
The study is currently enrolling patients at ~150 centers throughout the US and Canada.
Eligible Patients:
This clinical research study is for adults aged 40-85 with a diagnosis of COPD for at least 1 year prior to enrollment.
Contacts:
Date Posted:
April 22, 2022
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MIST PPF Study
Company:
Avalyn Pharma
Clinical Trial Title:
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Clinical Trial Description:
MIST PPF Study is a global Phase 2b clinical research study to evaluate the safety and efficacy of AP01 (inhaled pirfenidone) in patients with progressive pulmonary fibrosis, who show worsening symptoms and/or decline in lung function. This randomized, double-blind, placebo-controlled study is expected to enroll approximately 300 individuals with progressive pulmonary fibrosis across North America, South America, Europe, and Asia-Pacific.
The primary endpoint of the study is change from baseline in forced vital capacity (FVC) at Week 52. Secondary endpoints include quality of life measurements, time to disease progression, and change in lung fibrosis score based on high-resolution computed tomography (HRCT). Additional exploratory outcomes, including those related to lung function and respiratory hospitalization, will also be evaluated.
Eligible Patients:
This clinical research study is for adults age 18 and older with progressive pulmonary fibrosis (PPF), who show worsening symptoms and/or decline in lung function. Patients can be on background immunosuppressants or oral nintedanib.
Please visit the study website or the study’s ClinicalTrials.gov page (NCT06329401) using the link below to view the full eligibility criteria.
Contacts:
Name: Craig Conoscenti, MD
Phone Number: 206-707-0304
Email: cconoscenti@avalynpharma.com
Name: Daniele Tompkins
Phone Number: 973-983-3700 (ext 205)
Email: dtompkins@devprobiopharma.com
Date Posted:
September 27, 2024
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MOONSCAPE
Company:
Genentech (A member of the Roche Group)
Clinical Trial Title:
MOONSCAPE
Clinical Trial Description:
For patients with idiopathic pulmonary fibrosis (IPF) or with systemic sclerosis-associated interstitial lung disease (SSc-ILD) who may be or not already be on treatment, Genentech (a member of the Roche Group) is running a Global Multicenter Phase 2 study (MOONSCAPE) to evaluate the safety and efficacy of vixarelimab compared with placebo. The primary efficacy endpoint being studied is the change from baseline in forced vital capacity (FVC). Patients who complete the 52-week double-blinded period will be eligible to continue into an open-label extension. A number of clinical trial sites are available and recruiting patients across the United States and other countries.
Eligible Patients:
This clinical research study is for adults aged 18 to 85 years old diagnosed with idiopathic pulmonary fibrosis (IPF) or with systemic sclerosis-associated interstitial lung disease (SSc-ILD).
Contacts:
Genentech Trial Information and Support Team at +1 (888) 662-6728
Date Posted:
October 9, 2023
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MOONBEAM
Company:
Merck Sharp & Dohme LLC
Clinical Trial Title:
A Phase 2 Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Sotatercept (MK-7962) in Children From 1 to Less Than 18 Years of Age With PAH on Standard of Care
Clinical Trial Description:
The primary objectives of the study are to evaluate the safety and tolerability, and pharmacokinetics (PK) of sotatercept over 24 weeks of treatment in children ≥1 to <18 years of age with PAH World Health Organization (WHO) Group 1 on standard of care (SoC). There is no formal hypothesis.
Eligible Patients:
This clinical research study is for children from 1 to less than 18 years of age.
Contacts:
1-888-577-8839 or Trialsites@merck.com
Date Posted:
September 5, 2023
Learn more about this clinical trial
NATRON
Company:
AstraZeneca
Clinical Trial Title:
A Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled, 24-week Phase 3 Study with an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab in Patients with Hypereosinophilic Syndrome (HES) (NATRON).
Clinical Trial Description:
Hypereosinophilic Syndrome (HES) is a devastating and potentially fatal disease that can cause damage to multiple organs and systems. Benralizumab is an afucosylated monoclonal IgG1 antibody that selectively targets IL-5Rα. Treatment with Benralizumab have demonstrated reductions in exacerbations, improvements in lung function and symptoms in severe eosinophilic asthmatics. NATRON clinical research study will evaluate the potential benefit of if Benralizumab in the treatment of HES. The study will enroll approximately 120 eligible patients in 12 countries.
Eligible Patients:
The target patient population is male and female patients 12 years of age and older with symptomatic active HES.
Contacts:
AstraZeneca Clinical Study Information Center
1-877-240-9479
information.center@astrazeneca.com
Date Posted:
February 17, 2022
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NIMBLE
Company:
GlaxoSmithKline
Clinical Trial Title:
A Study of GSK3511294 (Depemokimab) Compared With Mepolizumab or Benralizumab in Participants With Severe Asthma With an Eosinophilic Phenotype (NIMBLE)
Clinical Trial Description:
This study will assess whether switching participants who have benefitted from mepolizumab or benralizumab to GSK3511294 (Depemokimab) is non-inferior to maintaining current treatment on the annualized rate of clinically significant exacerbations in participants with severe asthma with an eosinophilic phenotype. Throughout the study, all participants will continue their non-biologic Baseline standard of care (SoC) asthma treatment.
Eligible Patients:
This clinical research study is for participants 12 Years and older with severe Asthma. For Germany, UK and Norway only adult participants (≥18 years) are to be included in this clinical trial and ≥16 years in Austria.
Contacts:
trial_information_depemokimab@gsk.com
Date Posted:
August 14, 2023
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OBERON
Company:
AstraZeneca
Clinical Trial Title:
Efficacy and Safety of Tozorakimab (MEDI3506) in Symptomatic Chronic Obstructive Pulmonary Disease with a History of Exacerbations.
Clinical Trial Description:
OBERON is one out of two identical global phase 3 trials to evaluate the efficacy and safety of Tozorakimab (MEDI3506) administered subcutaneously in adult participants with symptomatic COPD with a history of exacerbations of COPD in the previous 12 months. Participants should be receiving optimized treatment with maintenance inhaled triple or dual therapy if triple is not indicated or contraindicated, at a stable dose for at least the last 3 months.
Recruitment is currently ongoing and is planned to continue until June 2024. Approximately 1272 participants will be randomized to receive treatment with Tozorakimab (MEDI3506) or matching placebo for 52 weeks on top of standard of care.
The OBERON study will be conducted at about 275 sites in 20 countries: Argentina, Belgium, Bulgaria, Canada, Czech Republic, Denmark, Finland, Hungary, India, Japan, Mexico, Netherlands, Norway, Portugal, South Korea, Spain, Sweden, Turkey, US and Vietnam.
Eligible Patients:
This clinical research study is for adults age 40 and older with a diagnosis of COPD for at least one year prior to enrollment.
Contacts:
AstraZeneca Clinical Study Information Center
1-877-240-9479
information.center@astrazeneca.com
Date Posted:
March 1, 2022
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PHINDER
Company:
United Therapeutics Corporation
Clinical Trial Title:
Pulmonary Hypertension Screening in Patients With Interstitial Lung Disease for Earlier Detection (PHINDER)
Clinical Trial Description:
In this study, subjects will undergo a broad range of clinical assessments that are potentially associated with PH. Study data will be used to identify and weigh specific clinical parameters based on their prognostic significance for right heart catheterization (RHC)-confirmed PH. There is no study drug under investigation in this study. The study consists of 2 study visits: a Screening Visit and Study Visit 1.
Clinical assessments include pulmonary function tests (PFTs); high resolution computed tomography (HRCT); physical examination; 6-Minute Walk Test; blood draw for clinical laboratory parameters, plasma brain natriuretic peptide (BNP) concentration and plasma N-terminal pro-BNP (NT-proBNP) concentration; echocardiography; University of California San Diego Shortness of Breath Questionnaire (UCSD SOBQ); King's Brief Interstitial Lung Disease Questionnaire (K-BILD); 36-Item Short Form Survey (SF-36); Pulmonary Hypertension Functional Classification Self Report (PH-FC-SR); Investigator's Suspicion of PH Questionnaire; adverse event (AE) monitoring; and RHC.
As the primary objective of this study is to collect a broad range of clinical parameters in patients with ILD, it is expected that numerous exploratory and post-hoc analyses will be performed to identify and weigh specific parameters based on their prognostic significance for PH in this patient population with the goal of developing a screening algorithm for PH in patients with ILD.
Eligible Patients:
Patients with PH-ILD being treated in any setting, including academic, community, etc.
Visit the study’s CT.gov page using the link below to view the full eligibility criteria.
Contact:
United Therapeutics Global Medical Information
Phone Number: 919-485-8350
Email: clinicaltrials@unither.com
Date Posted:
June 27, 2024
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PILLAR
Company:
Chiesi Farmaceutici S.p.A.
Clinical Trial Title:
A 52-week, Randomized, Double-blind, Double-dummy, Placebo- and Active- Controlled (Roflumilast, Daliresp® 500μg), Parallel group, Study to Evaluate the Efficacy and Safety of Two Doses of CHF6001 DPI add-on to Maintenance Tiple Therapy in subjects with Chronic Obstructive Pulmonary Disease (COPD) and chronic bronchitis.
Clinical Trial Description:
PILLAR is a clinical research study for adults with severe to very severe chronic obstructive pulmonary disease (COPD) and chronic bronchitis phenotype to evaluate CHF6001 (tanimilast), an inhaled investigational study drug, as add-on to maintenance triple therapy (ICS, LABA, LAMA). The study will randomize approximately 3,980 individuals with COPD in approximately 450 global study centers worldwide.
Eligible Patients:
This clinical research study is for adults age 40 and older, COPD diagnosis for at least 12 months prior to screening, post-BD FEV1 <50% of the patient predicted normal value, with chronic bronchitis or mixed phenotype. Subjects should be on background triple therapy at least 3 months prior to the screening visit and have at least one moderate or severe COPD exacerbation in the previous year.
Contacts:
A Clinical Trials Contact: clinicaltrials_info@chiesi.com
Date Posted:
February 1, 2024
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RESOLUTE
Company:
AstraZeneca
Clinical Trial Title:
A Multicenter, Randomized, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Benralizumab 100 mg in Patients with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) with a History of Frequent COPD Exacerbations and Elevated Peripheral Blood Eosinophils (RESOLUTE)
Clinical Trial Description:
RESOLUTE is a study to evaluate the efficacy and safety of a benralizumab in patients with moderate to very severe COPD with a history of frequent COPD exacerbations and elevated peripheral blood eosinophils. Eosinophils are a type of blood cell that helps the body to fight infections and is involved in inflammation, immune and allergic reactions.
Eligible Patients:
Eligible patients must have a history of ≥2 COPD exacerbations that needed the use of oral or intravenous corticosteroids for at least 3 days and/or hospitalizations in the previous year despite receiving stable triple optimized treatment (ICS/LABA/LAMA) for at least 3 months and dual inhaled treatment, where one of the medications must be an inhaled corticosteroid, for the remainder of the year.
Patients who fulfill those criteria will undergo a run-in period with additional tests to confirm eligibility for the study.
Contacts:
AstraZeneca Clinical Study Information Center
- 1-877-240-9479
- information.center@astrazeneca.com
Date Posted:
March 1, 2022
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SUPERNOVA
Company:
AstraZeneca
Clinical Trial Title:
SUPERNOVA clinical research study to protect immunocompromised people from COVID-19
Clinical Trial Description:
SUPERNOVA is a pivotal Phase I/III trial for AZD3152, a next-generation long-acting antibody developed to protect and treat vulnerable patients such as the immunocompromised from COVID-19.
Eligible Patients:
You or someone you care for, may be able to take part if you/they:
- Are 18 years of age or older and have an impaired immune system
- Have not tested positive for COVID-19 or received a COVID-19 vaccine in the past three months
- Weigh at least 40 kg
Contacts:
- Rachael Harleman (Director, Corporate Affairs, US Respiratory and Immunology)
rachael.harleman@astrazeneca.com - Blake McEvoy (Head of US Corporate Affairs, Respiratory & Immunology, Vaccines & Immune Therapies)
Blake.McEvoy@astrazeneca.com
Date Posted:
August 30th, 2023
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SUSPIRE-1
Company:
Areteia
Clinical Trial Title:
SUSPIRE-1
Clinical Trial Description:
SUSPIRE-1 is an open-label Phase II study assessing the PD of dexpramipexole 150 mg twice daily (BID) in participants with eosinophilic COPD. This study will help characterize the profile and duration of reductions of blood absolute eosinophil counts (AEC). The study will enroll approximately 30 patients with COPD in at approximately 20 study centers throughout the United States.
Eligible Patients:
This clinical research study is for adults age 40 and older.
Contacts:
Phone Number:888-584-9281
Email: clinicaltrials@areteiatx.com
Date Posted:
September 19, 2024
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TETON-1
Company:
United Therapeutics Corporation
Clinical Trial Title:
A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis (TETON)
Clinical Trial Description:
This is a is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the superiority of inhaled treprostinil against placebo for the change in absolute FVC in subjects with IPF over a 52-week period. Subjects will be randomly allocated 1:1 to receive inhaled treprostinil or placebo. All subjects will initiate inhaled treprostinil or placebo at a dose of 3 breaths administered 4 times daily (QID) and will titrate to a target dosing regimen of 12 breaths QID. Study drug doses may be titrated up as tolerated, until the target dose or maximum clinically tolerated dose is achieved. Once eligible, 6 Treatment Period visits to the clinic will be required at Weeks 4, 8, 16, 28, 40, and 52.
Efficacy assessments include spirometry (FVC), time to clinical worsening, time to first acute exacerbation of IPF, overall survival, King's Brief Interstitial Lung Disease (K-BILD) questionnaire, plasma N-terminal pro-brain natriuretic peptide (NT-proBNP) concentration, supplemental oxygen use, and lung diffusion capacity (DLCO). Safety assessments include the development of adverse events (AEs)/serious adverse events (SAEs), vital signs, clinical laboratory parameters, and electrocardiogram (ECG) parameters.
Subjects who complete the Week 52 Visit may be offered the opportunity to enter an open-label extension (OLE) study after completing the final study visit.
Eligible Patients:
Subjects are ≥40 years of age and have a diagnosis of IPF based on the 2018 ATS/ERS/JRS/ALAT Clinical Practice Guideline (Raghu 2018) and confirmed by central review of high-resolution computed tomography (HRCT) (performed within the previous 12 months), and if available, surgical lung biopsy.
Visit the study’s ClinicalTrials.gov page using the link below to view the full eligibility criteria.
Contact:
United Therapeutics Global Medical Information
Phone Number: 919-485-8350
Email: clinicaltrials@unither.com
Date Posted:
June 27, 2024
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TETON-2
Company:
United Therapeutics Corporation
Clinical Trial Title:
A Randomized, Double-blind, Placebo-controlled, Multinational, Phase 3 Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis (TETON-2)
Clinical Trial Description:
Study RIN-PF-303 is a multinational, randomized, double-blind, placebo-controlled study to evaluate the superiority of inhaled treprostinil against placebo for the change in absolute FVC in subjects with IPF over a 52-week period. Subjects will be randomly allocated 1:1 to receive inhaled treprostinil or placebo. All subjects will initiate inhaled treprostinil or placebo at a dose of 3 breaths administered 4 times daily (QID) and will titrate to a target dosing regimen of 12 breaths QID. Study drug doses may be titrated up as tolerated, until the target dose or maximum clinically tolerated dose is achieved. Once eligible, 6 Treatment Period visits to the clinic will be required at Weeks 4, 8, 16, 28, 40, and 52.
Efficacy assessments include spirometry (FVC), time to clinical worsening, time to first acute exacerbation of IPF, overall survival, King's Brief Interstitial Lung Disease (K-BILD) questionnaire, plasma N-terminal pro-brain natriuretic peptide (NT-proBNP) concentration, supplemental oxygen use, and lung diffusion capacity (DLCO). Safety assessments include the development of adverse events (AEs)/serious adverse events (SAEs), vital signs, clinical laboratory parameters, and electrocardiogram (ECG) parameters.
Subjects who complete the Week 52 Visit may be offered the opportunity to enter an open-label extension (OLE) study after completing the final study visit.
Eligible Patients:
Subjects are ≥40 years of age and have a diagnosis of IPF based on the 2018 ATS/ERS/JRS/ALAT Clinical Practice Guideline (Raghu 2018) and confirmed by central review of high-resolution computed tomography (HRCT) (performed within the previous 12 months), and if available, surgical lung biopsy.
Visit the study’s ClinicalTrials.gov page using the link below to view the full eligibility criteria.
Contact:
United Therapeutics Global Medical Information
Phone Number: 919-485-8350
Email: clinicaltrials@unither.com
Date Posted:
June 27, 2024
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TETON-PPF
Company:
United Therapeutics Corporation
Clinical Trial Title:
A Randomized, Double-blind, Placebo-controlled, Multinational, Phase 3 Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Progressive Pulmonary Fibrosis (TETON-PPF)
Clinical Trial Description:
This is a Phase 3, multinational, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of inhaled treprostinil in subjects with PPF over a 52-week period. Subjects will be randomly allocated 1:1 to receive inhaled treprostinil or placebo. All subjects will initiate inhaled treprostinil or placebo at a dose of 3 breaths administered 4 times daily (QID) and will titrate to a target dosing regimen of 12 breaths QID. Study drug doses may be titrated up as tolerated, until the target dose or maximum clinically tolerated dose is achieved. Once eligible, 6 Treatment Period visits to the clinic will be required at Weeks 4, 8, 16, 28, 40, and 52.
Efficacy assessments include spirometry (forced vital capacity [FVC]), time to clinical worsening, time to first acute exacerbation of interstitial lung disease (ILD), overall survival, King's Brief Interstitial Lung Disease (K-BILD) questionnaire, plasma N-terminal pro-brain natriuretic peptide (NT-proBNP) concentration, supplemental oxygen use, and lung diffusion capacity (DLCO). Safety assessments include the development of adverse events (AEs)/serious adverse events (SAEs), vital signs, clinical laboratory parameters, and electrocardiogram (ECG) parameters.
Subjects who complete the Week 52 Visit may be offered the opportunity to enter an open-label extension (OLE) study after completing the final study visit.
Eligible Patients:
Subjects are ≥18 years of age and have a diagnosis of PPF (other than IPF).
Visit the study’s ClinicalTrials.gov page using the link below to view the full eligibility criteria.
Contact:
United Therapeutics Global Medical Information
Phone Number: 919-485-8350
Email: clinicaltrials@unither.com
Date Posted:
June 27, 2024
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TITANIA
Company:
AstraZeneca
Clinical Trial Title:
TITANIA
Efficacy and Safety of Tozorakimab (MEDI3506) in Symptomatic Chronic Obstructive Pulmonary Disease with a History of Exacerbations.
Clinical Trial Description:
TITANIA is one out of two identical global phase 3 trials conducted to evaluate the efficacy and safety of Tozorakimab (MEDI3506) administered subcutaneously in adult participants with symptomatic COPD with a history of exacerbations of COPD in the previous 12 months. Participants should be receiving optimized treatment with maintenance inhaled triple or dual therapy if triple is not indicated or contraindicated, at a stable dose for at least the last 3 months.
Recruitment is currently ongoing and is planned to continue until June 2024. Approximately 1272 participants will be randomized to receive treatment with Tozorakimab (MEDI3506) or matching placebo for 52 weeks on top of standard of care.
The TITANIA study will be conducted at about 250 sites in 19 countries: Australia, Brazil, Chile, China, Colombia, France, Germany, Greece, Israel, Italy, Peru, Philippines, Poland, Romania, Russia, Taiwan, Thailand, UK and US.
Eligible Patients:
This clinical research study is for adults age 40 and older with a diagnosis of COPD for at least one year prior to enrolment.
Contacts:
AstraZeneca Clinical Study Information Center
- 1-877-240-9479
- information.center@astrazeneca.com
Date Posted:
March 1, 2022
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TRITON
Company:
Chiesi Farmaceutici S.p.A.
Clinical Trial Title:
A Phase III, 52-week, Multinational, Multicenter, Randomized, Double-blind, 2-arm Parallel Group Study Comparing Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination of Beclomethasone Dipropionate Plus Formoterol Fumarate Plus Glycopyrronium Bromide (CHF 5993) With the Fixed Dose Dual Combination of Beclomethasone Dipropionate Plus Formoterol Fumarate (CHF 1535), Both Administered Via pMDI in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Clinical Trial Description:
TRITON is a clinical research study for adults with moderate to severe chronic obstructive pulmonary disease (COPD) to compare CHF 5993 with CHF 1535, in improving lung function, reducing moderate and severe COPD exacerbations, and other clinical efficacy and safety outcomes. The study will enroll approximately 2900 individuals with COPD at approximately 360 global centers.
Eligible Patients:
This study is for adults age ≥ 40 years with a COPD diagnosis for at least 12 months, and a post-BD FEV1<50% predicted normal and a history of ≥1 moderate or severe COPD exacerbation in the previous 12 months OR a post-bronchodilator FEV1 ≥50% and <80% of predicted normal and a documented history of ≥2 moderate COPD exacerbations or ≥1 severe COPD exacerbation in the previous 12 months.
Contacts:
A Clinical Trials Contact: clinicaltrials_info@chiesi.com
Date Posted:
February 1, 2024