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 2017 Lung Disease Week site. 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 Kaganovskaya 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 Pneumonia

Intubated and Mechanically Ventilated Patients


acoustics

ACOUSTICS

Company:

Genentech, Inc./Roche

Clinical Trial Title:

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety and Tolerability of Lebrikizumab in Adolescent Patients With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and a Second Controller Medication

Clinical Trial Description:

ACOUSTICS is a Phase III study evaluating the efficacy, safety and tolerability of lebrikizumab in adolescent patients with asthma whose disease remains uncontrolled despite guideline-based asthma therapy.

Eligible Patients:

Adolescent (12-17 years) patients with asthma who continue to have symptoms after receiving treatment with an inhaled corticosteroid and a second controller medication for at least 6 months may be considered for this clinical trial.

Date Posted:

August 28, 2014

Learn more about this clinical trial


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

Learn more about these trials


Boehringer Ingelheim

Boehringer Ingelheim Asthma Study
Building Awareness for Severe Asthma

Company:

Boehringer Ingelheim

Clinical Trial Title:

Building Awareness for Severe Asthma

Clinical Trial Description:

A phase IIa, randomized, double-blind, placebo controlled, parallel group study to assess the safety and efficacy of subcutaneously administered BI 655066 /Abbv- 066 (risankizumab) as add-on therapy over 24 weeks in patients with severe persistent asthma.

Eligible Patients:

This clinical research study is for adults age 18 to 75.

Contacts:

Contact: Philip Arnold at philip.arnold@boehringer-ingelheim.com

Date Posted:

November 10, 2016

Learn more about this clinical trial


Covert

C38072-AS-30027 (NCT02501629)

Company:

Teva Branded Pharmaceutical Products, R&D Inc

Clinical Trial Title:

A Phase 3, 24-Week Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Study of Reslizumab Subcutaneous Dosing (110 mg Every 4 Weeks) in Patients With Oral Corticosteroid Dependent Asthma and Elevated Blood Eosinophils  

Clinical Trial Description:

The primary objective of the study is to determine the ability of reslizumab administered subcutaneously to produce a corticosteroid-sparing effect in patients with oral corticosteroid (OCS)-dependent asthma and elevated blood eosinophils, without loss of asthma control. The study will enroll approximately 152 patients at approximately 136 study centers in 18 countries worldwide. 

Eligible Patients:

This study will enroll male and female patients, 12 years of age and older, with oral corticosteroid (OCS)-dependent asthma and elevated eosinophils.

Contacts:

Teva Medical Information 1-800-896-5855  

Date Posted:

April 19, 2015

Learn more about this clinical trial


CLAVIER

Company:

Genentech

Clinical Trial Title:

A Phase II, Randomized, Double-Blind, Placebo-Controlled Bronchoscopy Study to Evaluate the Effects of Lebrikizumab on Airway Eosinophilic Inflammation in Patients With Uncontrolled Asthma on Inhaled Corticosteroids and a Second Controller Medication (CLAVIER)

Clinical Trial Description:

CLAVIER is a Phase II bronchoscopy study evaluating the effects of lebrikizumab on airway eosinophilic inflammation in patients with asthma whose disease remains uncontrolled despite guideline-based asthma therapy.

Eligible Patients:

Adult patients with asthma who continue to have symptoms after receiving treatment with an inhaled corticosteroid and a second controller medication for at least 6 months may be considered for this clinical trial.

Date Posted:

August 28, 2014

Learn more about this clinical trial


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

Learn more about this clinical trial


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

Learn more about this clinical trial


Bayer

INHALE

Company:

Bayer HealthCare AG / Nektar

Clinical Trial Title:

INHALE 1
INHALE 2

A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety
and Efficacy of Amikacin Inhale as Adjunctive Therapy in Intubated and Mechanically-Ventilated Patients With Gram-Negative Pneumonia

Amikacin Inhale is an investigational drug-device combination.

Clinical Trial Description:

To demonstrate that as adjunctive therapy to intravenous (IV) antibiotics, Amikacin Inhale 400 mg administered as an aerosol by the Pulmonary Drug Delivery System (PDDS) every 12 hours is safe and more effective than placebo (aerosolized normal saline) administered as an aerosol by the PDDS every 12 hours, in intubated and mechanically-ventilated patients with Gram-negative Pneumonia. The secondary endpoint objectives are to evaluate the superiority of Amikacin Inhale versus aerosolized placebo in pneumonia-related mortality, the Early Clinical Response at Day 10, the days on ventilation, and the days in the intensive care unit (ICU).

Eligible Patients:

  • Adult males and non-pregnant, non-lactating females, intubated and mechanically ventilated
    patients with diagnosis of pneumonia defined as presence of a new or progressive infiltrate(s)
    on chest radiograph
  • Presence of Gram-negative organism(s) by either Gram stain or culture of respiratory
    secretions, or suspected Gram-negative pathogen
  • Impaired oxygenation
  • Clinical Pulmonary Infection Score (CPIS) of at least 6
  • At least two risk factors for multi-drug resistant organisms

Contact:

clinical‐trials‐contact@bayerhealthcare.com

Date Posted:

March 3, 2017

Learn more about these trials:

https://www.clinicaltrials.gov/ct2/show/NCT01799993

http://www.clinicaltrials.gov/ct2/show/NCT00805168


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

Learn more about this clinical trial


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

Learn more about this clinical trial


PF-ILD

PF-ILD

Company:

Boehringer-Ingelheim

Clinical Trial Title:

PF-ILD

Clinical Trial Description:

PF-ILD is a clinical research study for adults with progressive fibrosing interstitial lung disease (PF-ILD), including idiopathic interstitial pneumonias, chronic fibrosing hypersensitivity pneumonitis, and connective tissue disease (RA or SSc) with associated ILD, to evaluate an oral investigational study drug. The study will enroll approximately 600 individuals with a PF-ILD in at approximately 100 study centers in the US, Canada, and approximately 10 to 12 additional countries.

Eligible Patients:

This clinical research study is for adults age 18 and older.

Contacts:

1-800-243-0127
clintriage.rdg@boehringer-ingelheim.com

Date Posted:

June 7, 2017

Learn more about this clinical trial


pearl

PT008001

Company:

Pearl Therapeutics, Inc.

Clinical Trial Title:

PT008001

Clinical Trial Description:

PT008001 is a clinical research study for adults with mild to moderate persistent asthma. The study will enroll approximately 150 individuals with Asthma in at approximately 45 study centers throughout the United States.

Eligible Patients:  

This clinical research study is for adults age 18 - 65.

Date Posted:

October 20, 2014

Learn more about this clinical trial


RIFF

Company:

Genentech

Clinical Trial Title:

A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Lebrikizumab in Patients With Idiopathic Pulmonary Fibrosis

Clinical Trial Description:

RIFF is a Phase II study evaluating the safety and efficacy of lebrikizumab in patients with IPF. The primary outcome measure for the study is Progression Free Survival.

Eligible Patients:

Adult patients ≥ 40 years of age with a definite diagnosis of IPF according to the 2011 ATS/ERS/JRS/ALAT consensus statement on IPF within the previous 4 years from the time of screening.

Date Posted:

August 28, 2014

Learn more about this clinical trial


SENSCIS

SENSCIS

Company:

Boehringer-Ingelheim Pharmaceuticals Inc

Clinical Trial Title:

SENSCIS TM A double blind, randomized, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with ‘Systemic Sclerosis associated Interstitial Lung Disease’ (SSc-ILD).

Clinical Trial Description:

SENSCISTM describes a clinical research study for adults with Scleroderma (SSc) with interstitial Lung Disease (ILD) to evaluate an investigational study drug, Nintedanib. Nintedanib is an oral drug that has been approved in the United States and Europe to treat idiopathic pulmonary fibrosis, which is a disease similar to SSc-ILD. However, Nintedanib has not been approved to treat SSc-ILD and is considered an investigational drug for the purposes of this study. Individuals will take the capsule twice a day for at least 52 weeks and up to a maximum of 100 weeks. Total participation in the study will last between 56 and 104 weeks (1 to 2 years). If the individual completes all visits in the study, they may have the opportunity to participate in an extension study in which all participants will receive Nintedanib.

In the US, the study will enroll approximately 82 participants with SSc-ILD at approximately 47 study centers. Internationally, the study will enroll 530 participants at approximately 180 study centers in 20 countries (including the US).

Eligible Participants:

  • Be 18 years of age or older
  • Have developed Systemic Sclerosis (SSc) within the past 5 years
  • Be diagnosed with SSc-ILD
  • Have had no previous treatment with nintedanib or pirfenidone
  • Have no history of stroke within 12 months.
  • There are other inclusion and exclusion criteria but the above are the major factors.

Date Posted: 04/04/2016

Learn more about this clinical trial


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


VOCALS

Company:

Genentech

Clinical Trial Title:

A Phase II, Randomized, Double-Blind, Placebo-Controlled Multicenter Trial to Assess the Oral Corticosteroid-Sparing Effect of Lebrikizumab in Patients with Severe Corticosteroid-Dependent Asthma

Clinical Trial Description:

VOCALS is a Phase II study evaluating the efficacy of lebrikizumab as measured by the ability to achieve lower daily doses of oral corticosteroids in patients with severe corticosteroid-dependent asthma.

Eligible Patients:

Adult patients with severe asthma despite intensive follow-up by an asthma specialist and on chronic treatment with maintenance oral corticosteroids for at least 6 months may be considered for this trial.

Date Posted:

August 28, 2014

Learn more about this clinical trial

Last Reviewed: August 2017