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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/.

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 Bronchiectasis

Trials in COPD

Trials in Idiopathic Pulmonary Fibrosis (IPF)

Trials in Influenza

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


Elevate

Altavant Sciences

Company:

Altavant Sciences

Clinical Trial Title:

A Study of Rodatristat Ethyl in Patients with Pulmonary Arterial Hypertension (ELEVATE 2)

Clinical Trial Description:

ELEVATE 2 is a Phase 2b clinical research study to evaluate the safety and efficacy of Rodatristat Ethyl for the treatment of adult patients with pulmonary arterial hypertension (PAH). The study is expected to enroll 90 patients at expert centers in the US, Canada and Europe.

Eligible Patients:

This clinical research study is for adults age 18 years and older diagnosed with symptomatic PAH belonging to WHO Group 1 on a stable treatment regimen with one or more approved PAH treatments.

Contacts:

Watiri Kamau-Kelley
watiri@altavant.com

Howard Lazarus, MD
howard.lazarus@altavant.com

Date Posted:

March 2, 2021

Learn more about this clinical trial

Additional Information


Aspen

ASPEN

Company:

Insmed Incorporated

Clinical Trial Title:

A Phase 3, Randomized, Double blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects With Non-Cystic Fibrosis Bronchiectasis - The ASPEN Study

Clinical Trial Description:

ASPEN is a clinical research study for adults with a clinical diagnosis of non-cystic fibrosis bronchiectasis (NCFBE) to evaluate an investigational study drug (brensocatib). The study will enroll approximately 1620 individuals with NCFBE in at approximately 480 study centers globally.

Eligible Patients:

This clinical research study is for adults age 18 to 85 with a clinical history consistent with NCFBE that is confirmed by chest computerized tomography scan, and a history of at least 2 pulmonary exacerbations in the prior 12 months.

Contacts:

Insmed Medical Information
844-4-INSMED
medicalinformation@insmed.com

Date Posted:

February 17, 2021

Learn more about this clinical trial

Additional Information


Centerstone

CENTERSTONE

Company:

Genentech, a Member of the Roche Group

Clinical Trial Title:

CENTERSTONE

Clinical Trial Description:

CENTERSTONE is a study to assess the efficacy of a single oral dose of baloxavir marboxil versus placebo to reduce the direct transmission of influenza A or B in households and is taking place at multiple sites around the United States and other countries.

Eligible Patients:

CENTERSTONE is open to otherwise-healthy participants between the ages of 5 and 64 with confirmed influenza infection, who have had influenza symptoms for no more than 48 hours. Participants must also have at least 2 household members who are confirmed influenza-negative and are willing to participate.

Contacts:

For more information or to locate a site near you, please visit  https://www.centerstoneflutrial.com/en-us/

Date Posted:

February 17, 2021

Learn more about this clinical trial


Eduro

EDURO

Company:

Genentech

Clinical Trial Title:

a multicenter, open-label, single-arm study to assess the impact of omalizumab on exercise capacity, physical activity and sleep quality in patients with moderate to severe allergic asthma

Clinical Trial Description:

The EDURO study is a clinical research study for adults with moderate to severe allergic asthma to assess whether omalizumab can improve the ability to do exercise, be physically active and sleep better. The ability to exercise will be tested using cardiopulmonary exercise testing. Patients will also be provided with a wrist worn activity and sleep monitor and eDiary to assess the impact on physical activity and sleep. The study will be conducted in approximately 20 centers in the United States and aim to enroll approximately 60 patients.

Eligible Patients:

This clinical research study is for adults age 18-65, who have moderate to severe uncontrolled allergic asthma, as confirmed by a positive skin prick test or blood test for perennial allergens.

Contact:

A Clinical Trials Information Support 1-888-662-6728

Date Posted:

February 17, 2021

Learn more about this clinical trial  

or Watch the patient information video


Verona

ENHANCE 1 Trial

Company:

Verona Pharma

Clinical Trial Title:

ENHANCE 1 clinical trial

Clinical Trial Description:

The ENHANCE 1 ( Ensifentrine as a Novel In HAled Nebulized COPD th Erapy) clinical trial is a clinical research study for adults with moderate to severe chronic obstructive pulmonary disease (COPD), including patients on no maintenance/background therapy or patients on stable maintenance LAMA or LABA therapy. The study will enroll approximately 800 individuals with COPD at approximately 100 study centers throughout the United States, Europe, Russia, and South Korea and will last up to 48 weeks.

Eligible Patients:

This clinical research study is for adults age 40 and older.

Contacts:

A Clinical Trials Contact
Robin Morris | Sr. Director | Verona Pharma
8045 Arco Corporate Drive, Suite 130
Raleigh, NC 27617 
M: (646)565-8944
Email: Robin.Morris@Veronapharma.com

Date Posted:

February 17, 2021

Learn more about this clinical trial


Verona

ENHANCE 2 Trial

Company:

Verona Pharma

Clinical Trial Title:

ENHANCE 2 clinical trial

Clinical Trial Description:

The ENHANCE 2 ( Ensifentrine as a Novel In HAled Nebulized COPD th Erapy) clinical trial is a clinical research study for adults with moderate to severe chronic obstructive pulmonary disease (COPD), including patients on no maintenance/background therapy or patients on stable maintenance LAMA or LABA therapy. The study will enroll approximately 800 individuals with COPD in at approximately 100 study centers throughout the United States and Europe and will last 24 weeks.

Eligible Patients:

This clinical research study is for adults age 40 and older.

Contacts:

Robin Morris | Sr. Director | Verona Pharma
8045 Arco Corporate Drive, Suite 130
Raleigh, NC 27617 
M: (646)565-8944
Email: Robin.Morris@Veronapharma.com

Date Posted:

February 17, 2021

Learn more about this clinical trial


ARISE and ENCORE

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:

Learn more about this clinical trial

Additional Information #1

Additional Information #2

Date Posted:

June 7, 2021


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

Learn more about this clinical trial


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

Learn more about this clinical trial


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

Learn more about this clinical trial


Starscape

STARSCAPE

Company:

Genentech

Clinical Trial Title:

STARSCAPE

Clinical Trial Description:

For patients with IPF who may or may not already be taking either pirfenidone or nintedanib, Genentech is running a global multicenter phase 3 clinical trial to evaluate the safety and efficacy of recombinant human pentraxin-2 (rhPTX-2; also known as PRM-151). This phase 3 trial is being initiated based upon the results from the phase 2 trial of rhPTX-2 which demonstrated statistically significant and clinically meaningful outcomes in patients with IPF (Raghu et al, JAMA. 2018;319(22):2299-2307)

Eligible Patients:

This clinical research study is for adults aged 40 to 85, who have a diagnosis of IPF. Participants will be expected to demonstrate an FVC of at least 45% predicted and a minimum 6-minute walk distance of 150m.

Contacts:

please contact Genentech at: 888-662-6728, or visit this link

Date Posted:

February 17, 2021

Learn more about this clinical trial