Clinical Trials

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Clinical Trials

Welcome to our Clinical Trial 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 US Clinical Trial listing can be found at http://clinicaltrials.gov/.

Additional information on current Clinical Trials by Disease State can be found on the ATS 2019 Lung Disease Week. Please click on your Lung Disease Week of interest and then on “Information for Patients” on the top left menu to reach a resource portal including updated information on relevant clinical trials.

If you would like to receive information about new clinical trials listed on this page, please email us to join the Clinical Trial Listserve.


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 at vohara@thoracic.org.

Trials in Asthma

Trials in COPD

Trials in IPF

Trials in Interstitial Lung Disease (ILD)

Trials in Lung Infection

Trials in PAH

Trials in Pulmonary Hypertension (PH)

Trials in Pulmonary Fibrosis (PF)

Trials in Sarcoidosis


Bayer

BAY63-2521

Company:

Bayer AG

Clinical Trial Title:

BAY63-2521 REplacing PDE-5i therapy evaLuated Against Continued PDE-5i therapy

Clinical Trial Description:

A prospective, randomized, international, multicenter, double-arm, controlled, open-label, Phase IV study of BAY63-2521 in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal (defined as being World Health Organization Functional Class III and having a 6 Minute Walking Distance test between 165 m and 440 meters).

Eligible Patients:

  • Male and female patients aged 18 to 75 years with symptomatic Pulmonary Arterial Hypertension: pulmonary vascular resistance > 400 dyn*sec*cm-5 (5 Wood units), mean pulmonary artery pressure ≥ 25 mmHg, and pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg on right heart catheterization within 12 months prior to screening or PCWP can be replaced by left ventricular end-diastolic pressure ≤ 15 mmHg
  • PAH of the following types: Idiopathic, hereditary, drug/ toxin induced, associated with PAH due to Connective tissue disease, Congenital heart disease, but only if the patient underwent surgical repair more than one year before enrolment, portal hypertension with liver cirrhosis
  • Stable doses of a PDE-5i and ERA combination therapy or on stable PDE-5i monotherapy 6 weeks prior to and at randomization but not at treatment goal (tadalafil 20 to 40 mg once daily or sildenafil at least 60 mg daily dose)
  • World Health Organization Functional Class III at screening and at randomization
  • 6 Minute Walking Distance test between 165 m and 440 meters at screening and at randomization
  • Patients may be excluded if they have relevant obstructive and restrictive or other lung diseases. Exclusion criteria also include cardiovascular conditions such as left ventricular disease, coronary heart disease or stroke within previous 3 months.

Contact:

clinical‐trials‐contact@bayerhealthcare.com

Date Posted:

August 10, 2017

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Covert

CONVERT

Company:

Insmed Incorporated

Clinical Trial Title:

A Randomized, Open‑Label, Multicenter Study of Liposomal Amikacin for Inhalation (LAI) in Adult Patients with Nontuberculous Mycobacterial (NTM) Lung Infections caused by Mycobacterium avium complex (MAC) that are refractory to treatment (CONVERT)

Clinical Trial Description:

CONVERT is a clinical research study designed to evaluate an investigational medication—Liposomal Amikacin for Inhalation (LAI)—in adult patients with Nontuberculous Mycobacterial (NTM) lung infection caused by Mycobacterium avium Complex (MAC), who have not experienced success with previous treatments. The CONVERT study will take place in approximately 150 locations in North America, Europe, Asia-Pacific, and Australia.

Eligible Patients:

Patients must be 18 years of age or older at screening, and fulfill other eligibility criteria, including the willingness to adhere to a multi-drug treatment regimen during the course of the study.

Contacts:

NTMstudy@hudsonglobal.com or call 866-825-3418

Date Posted:

November 18, 2015

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Freesia

FREESIA

Company:

Janssen Sciences Ireland Unlimited Company  

Clinical Trial Title:

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Clinical Outcomes, Antiviral Activity, Safety, Tolerability, Pharmacokinetics, and Pharmacokinetics/Pharmacodynamics of JNJ-53718678 in Adult and Adolescent Hematopoietic Stem Cell Transplant Recipients with Respiratory Syncytial Virus Infection of the Upper Respiratory Tract

Clinical Trial Description:

The FREESIA study is a clinical research study to evaluate a study medicine in people who have had a stem cell transplant and have since been diagnosed with respiratory syncytial virus (RSV) of the upper airways. The safety and efficacy of using the study drug in RSV treatment for people with stem cell transplants has not yet been established.

The study will enroll approximately 300 individuals at approximately 100 study centers globally.

Eligible Patients:

Adult and adolescent stem cell transplant recipients aged 13 to 75 years of age, with respiratory syncytial virus infection of the upper respiratory tract and having started experiencing RSV symptoms within 4 days of beginning this study (like runny or stuffy nose, sneezing, cough, sore throat, and/or fever).

Date Posted:

01/17/2020

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Galathea

GALATHEA

Company:

AstraZeneca

Clinical Trial Title:

Randomised, Double-blind, 56 Week Placebo-controlled, Parallel Group, Multicentre, Phase 3 Study to Evaluate the Efficacy and Safety of 2 Doses of Benralizumab in Patients with Moderate to Very Severe COPD with a History of Exacerbations

Clinical Trial Description:

Galathea is a clinical research study for adults with severe to very severe COPD receiving standard
maintenance therapy (inhaled corticosteroid/long-acting β2 agonist (ICS/LABA), long-acting β2 agonist /long acting muscarinic antagonist (LABA/LAMA) or ICS/LABA/LAMA) with a history of COPD exacerbation(s) in the year prior to enrolment (Visit 1) to evaluate two doses of Benralizumab, a monoclonal antibody, in patients with eosinophils above and below 300 cells/microliter in a 2:1 ratio. The study will enroll patients with COPD at approximately 300 study centers throughout the world.

Eligible Patients:

Inclusion Criteria:

  • Informed consent.
  • Subjects 40-85 y.o.
  • Moderate to very severe COPD with Post Bronchodilator (BD) FEV1>20% and ≤65% and ≥2 moderate or ≥1 severe COPD exacerbation(s) (moderate exacerbation defined as requiring treatment with antibiotics or systemic steroid, severe exacerbation defined as hospitalization) within 2-52 weeks prior to Visit1.
  • Modified Medical Research Council (mMRC) score ≥1 at Visit 1.
  • Treatment with double or triple therapy throughout the year prior to Visit 1
  • Tobacco history of ≥10 pack-years.
  • Women of childbearing potential must use a highly effective form of birth control from Visit 1 until 16 weeks after their last dose, and negative serum pregnancy test result at Visit 1.
  • Male subjects who are sexually active must be surgically sterile one year prior to Visit 1 or use an adequate method of contraception from the first Investigational Product (IP) dose until 16 weeks after their last dose.
  • Compliance with maintenance therapy during run-in ≥70%.

 Exclusion criteria:

  • Clinically important pulmonary disease other than COPD or another diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts.
  • Any disorder or major physical impairment that is not stable by Investigator opinion and/or could affect: - subject safety−study findings or their interpretation or subject's ability to complete the entire study duration.
  • Unstable ischemic heart disease, arrhythmia, cardiomyopathy, or other relevant cardiovascular disorder that in Investigator's judgment may put the patient at risk or negatively affect the study outcome.
  • COPD exacerbation within 2 weeks prior to V1 or during enrollment and run in period
  • Acute upper or lower respiratory infection within 2 weeks prior to Visit1or during the enrolment and run-in period.
  • Pneumonia within 8 weeks prior to Visit1 or during the enrolment and run-in period.
  • Pregnant, breastfeeding, or lactating women.
  • Risk factors for pneumonia
  • History of anaphylaxis to any other biologic therapy.
  • Long term oxygen therapy with signs and/or symptoms of cor pulmonale or right ventricular failure.
  • Use of immunosuppressive medication within 2 weeks prior to Visit1 and/or during the enrolment and run-in period.
  • Receipt of any investigational non-biologic product within 30 days or 5 half-lives prior to Visit 1.
  • Evidence of active tuberculosis (TB), either treated or untreated, or latent TB without an appropriate course of treatment.
  • Lung volume reduction surgery within the 6 months prior to Visit 1. History of partial or total lung resection (single lobe or segmentectomy is acceptable).
  • Asthma as a primary or main diagnosis according to the Global Initiative for Asthma (GINA) guidelines or other accepted guidelines.
  • Previous treatment with benralizumab.
  • Helminth parasitic infection diagnosed within 24 weeks prior to Visit 1.

Contacts:

Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Date Posted:

06/18/2015

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ino-pf

iNO-PF

Company:

Bellerophon Therapeutics

Clinical Trial Title:

PULSE-PHPF-001:  A Randomized, Double-Blind, Placebo-Controlled Dose Escalation Study To Assess the Safety and Efficacy of Pulsed, Inhaled Nitric Oxide In Subjects with Pulmonary Hypertension Associated with Pulmonary Fibrosis On Oxygen Therapy

Clinical Trial Description:

iNO-PF is a clinical research study evaluating the efficacy, safety and optimal dose of pulse, inhaled nitric oxide (iNO) in adults with low or intermediate/high probability of pulmonary hypertension associated with pulmonary fibrosis (PH-PF).  The study will enroll approximately 80 individuals currently using oxygen therapy at approximately 40 study centers throughout the United States.  The use of additional approved therapies to treat pulmonary fibrosis is not exclusionary.

Eligible Patients:  

This study will enroll subjects age 18 to 85 diagnosed with pulmonary fibrosis by high resolution CT scan.

Contacts:

Contact: Deena Peace deena.peace@bellerophon.com

Date Posted:

January 16, 2019

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Insmed

INSMED

Company:

Insmed Incorporated

Clinical Trial Title:

A Randomized, Open-Label, Multicenter Study of Liposomal Amikacin for Inhalation (LAI) in Adult Patients with Nontuberculous Mycobacterial (NTM) Lung Infections caused by Mycobacterium avium complex (MAC) that are refractory to treatment

Clinical Trial Description:

Insmed is conducting a Randomized, Phase III, Open-label study, to evaluate the effectiveness of Liposomal Amikacin for Inhalation (LAI) when added to multi-drug regimen in subjects with Nontuberculous Mycobacterial (NTM) lung infection caused by Mycobacterium Avium Complex (MAC). The clinical study will evaluate the benefits of adding LAI to current treatment regimens and also help understand what side effects LAI may cause in patients with MAC lung infection 

Eligible Patients:  

Patients must be 18 years of age or older at screening, and fulfill other eligibility criteria, including the willingness to adhere to a multi-drug treatment regimen during the course of the study.

Contacts:

Patricia Fortner; NTM@insmed.com

Date Posted:

March 11, 2015

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Isabela

ISABELA

Company:

GALAPAGOS N.V.

Clinical Trial Title:

A Phase 3, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Two Doses of GLPG1690 in Addition to Local Standard of Care for Minimum 52 Weeks in Subjects With Idiopathic Pulmonary Fibrosis

Clinical Trial Description:

The ISABELA program includes two identically designed, phase III international, randomized, double-blind, placebo‑controlled studies (ISABELA 1 and 2), conducted in parallel. It is planned that in each study, 750 subjects with IPF will be randomized 1:1:1 to receive either GLPG1690 high dose, GLPG1690 low dose, or placebo, once-daily, on top of local SOC, for at least 52 weeks. The primary objective of the studies is to evaluate the efficacy of two doses of GLPG1690 compared with placebo, each given in addition to local standard of care (SOC), in subjects with IPF, as assessed by the rate of decline of FVC over 52 weeks. Secondary objectives relate to efficacy, mortality, QoL, safety, tolerability and pharmacokinetics.

All patients are planned to continue in the study until the last subject reached 52 weeks in the study. Safety and tolerability will be assessed by adverse events, laboratory safety parameters, vital signs, electrocardiograms, and physical examination.

Eligible Patients:  

This clinical research study is for adults aged ≥40 years on the day of signing the ICF, with a diagnosis of IPF within 5 years prior to the screening visit as per applicable ATS/ERS/JRS/ALAT guidelines, and a chest HRCT historically performed within 12 months prior to the screening visit and according to the minimum requirements for IPF diagnosis by central review based on subject's HRCT. Other inclusion and exclusion criteria do apply.

Contacts:

Contact: Evelyn Fox, +3215342900, evelyn.fox@glpg.com

Date Posted:

May 14, 2019

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Additional Information #1

Additional Information #2


Covert

C38072-AS-30025

Company:

Teva Pharmaceuticals

Clinical Trial Title:

A 52-Week Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Study of Reslizumab 110 mg Fixed, Subcutaneous Dosing in Patients With Uncontrolled Asthma and Elevated Blood Eosinophils

Clinical Trial Description:

Protocol C38072-AS-30025 is a clinical research study to establish the safety and efficacy of the study drug for patients 12 and older with asthma and elevated blood eosinophils who are inadequately controlled on at least a medium total daily ICS dose and a second asthma controller.  The study will enroll approximately 400 patients at approximately 250 study centers in 22 countries worldwide.

Eligible Patients:

This clinical research study is for patients 12 and older with asthma and elevated blood eosinophils who are inadequately controlled on at least a medium total daily ICS dose and a second asthma controller.

Contacts:

Teva U.S. Medical Information 1-800-896-5855

Date Posted:

April 19, 2015

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Bellerophon

PULSE-PHPF-002

Company:

Bellerophon Therapeutics

Clinical Trial Title:

PULSE-PHPF-002:  An Acute Dose Escalation Clinical Study to Assess the Safety and Efficacy of Pulsed, Inhaled, Nitric Oxide (iNO) in Subjects with Pulmonary Hypertension Associated with Pulmonary Fibrosis or Sarcoidosis on Long Term Oxygen Therapy Followed by an Optional Open-Label Long Term Extension Safety Study

Clinical Trial Description:

PULSE-PHPF-002 is a clinical research study evaluating the efficacy, safety and optimal dose of pulse, inhaled nitric oxide (iNO) in adults with pulmonary hypertension associated with pulmonary fibrosis or sarcoidosis.  The study will enroll approximately 16 individuals currently using oxygen therapy at approximately 8 study centers throughout the United States.  The use of additional approved therapies to treat pulmonary fibrosis/sarcoidosis is not exclusionary.

Eligible Patients:  

This study will enroll subjects age 18 to 85 diagnosed with pulmonary fibrosis or sarcoidosis.

Contacts:

Contact: Valerie Parker valerie.parker@bellerophon.com

Date Posted:

January 16, 2019

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Terranova

TERRANOVA

Company:

AstraZeneca

Clinical Trial Title:

A Randomised, Double-blind, Double Dummy, 56 Week Placebo-controlled, Multicentre, Parallel Group, Phase 3 Study Evaluating Efficacy/Safety of 3 Benralizumab Doses in Patients with Moderate to Very Severe COPD with Previous Exacerbations

Clinical Trial Description:

Terranova is a clinical research study for adults with severe to very severe COPD receiving standard maintenance therapy (inhaled corticosteroid/long-acting β2 agonist (ICS/LABA), long-acting β2 agonist /long acting muscarinic antagonist (LABA/LAMA) or ICS/LABA/LAMA) with a history of COPD exacerbation(s) in the year prior to enrolment (Visit 1) to evaluate three doses Benralizumab, a monoclonal antibody, in patients with eosinophils above and below 300 cells/microliter in a 2:1 ratio. The study will enroll patients with COPD at approximately 300 study centers throughout the world.

Eligible Patients:

Inclusion Criteria:

  • Informed consent.
  • Subjects 40-85 y.o.
  • Moderate to very severe COPD with Post Bronchodilator (BD) FEV1>20% and ≤65% and ≥2 moderate or ≥1 severe COPD exacerbation(s) (moderate exacerbation defined as requiring treatment with antibiotics or systemic steroid, severe exacerbation defined as hospitalization) within 2-52 weeks prior to Visit1.
  • Modified Medical Research Council (mMRC) score ≥1 at Visit 1.
  • Treatment with double or triple therapy throughout the year prior to Visit 1
  • Tobacco history of ≥10 pack-years.
  • Women of childbearing potential must use a highly effective form of birth control from Visit 1 until 16 weeks after their last dose, and negative serum pregnancy test result at Visit 1.
  • Male subjects who are sexually active must be surgically sterile one year prior to Visit 1 or use an adequate method of contraception from the first Investigational Product (IP) dose until 16 weeks after their last dose.
  • Compliance with maintenance therapy during run-in ≥70%.

Exclusion criteria:

  • Clinically important pulmonary disease other than COPD or another diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts.
  • Any disorder or major physical impairment that is not stable by Investigator opinion and/or could affect: - subject safety−study findings or their interpretation or subject's ability to complete the entire study duration.
  • Unstable ischemic heart disease, arrhythmia, cardiomyopathy, or other relevant cardiovascular disorder that in Investigator's judgment may put the patient at risk or negatively affect the study outcome.
  • COPD exacerbation within 2 weeks prior to V1 or during enrollment and run in period
  • Acute upper or lower respiratory infection within 2 weeks prior to Visit1or during the enrolment and run-in period.
  • Pneumonia within 8 weeks prior to Visit1 or during the enrolment and run-in period.
  • Pregnant, breastfeeding, or lactating women.
  • Risk factors for pneumonia
  • History of anaphylaxis to any other biologic therapy.
  • Long term oxygen therapy with signs and/or symptoms of cor pulmonale or right ventricular failure.
  • Use of immunosuppressive medication within 2 weeks prior to Visit1 and/or during the enrolment and run-in period.
  • Receipt of any investigational non-biologic product within 30 days or 5 half-lives prior to Visit 1.
  • Evidence of active tuberculosis (TB), either treated or untreated, or latent TB without an appropriate course of treatment.
  • Lung volume reduction surgery within the 6 months prior to Visit 1. History of partial or total lung resection (single lobe or segmentectomy is acceptable).
  • Asthma as a primary or main diagnosis according to the Global Initiative for Asthma (GINA) guidelines or other accepted guidelines.
  • Previous treatment with benralizumab.
  • Helminth parasitic infection diagnosed within 24 weeks prior to Visit 1.

Contacts:

Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Date Posted:

06/18/2015

Learn more about this clinical trial