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Clinical Trials Registry

Our Clinical Trials Registry is a free service to connect physicians to clinical trials in respiratory disease conducted by participating pharmaceutical companies. Clinical trials power medical progress, allowing researchers to test new ways to prevent, detect, and treat respiratory disease. Without clinical trials, treatment advancements would be significantly hampered.

Ongoing groundbreaking research could have a measurable impact on patient care, but a lack of clinical trial participants is significantly slowing research and threatening the development of new treatments. Recruiting and retaining trial participants are the greatest challenges to developing the next generation of treatment options.

Participation in clinical trials provides an opportunity to advance and accelerate medical research and contribute to an improved health outlook for future generations. Use our registry to get information on how you can be involved in a clinical trial.

Bayer

 

BAY63-2521 Replacing PDE-5i therapy evaluated Against Continued PDE-5i therapy).

Company: Bayer AG
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).

 

Type of participant needed:

  • 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.

Posted: August 16, 2017

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SENSCIS

 

SENSCISTM 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).

Company: Boehringer-Ingelheim Pharmaceuticals Inc
Clinical trial description:  SENSCISTM  (Safety and Efficacy of Nintedanib in Systemic SClerosIS) describes a clinical research study for adults with Scleroderma (SSc) with interstitial Lung Disease (ILD) to evaluate an investigational 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 purpose of this study. Individuals will take the capsule twice a day for at least 52 weeks and up to a maximum of 100 weeks. The capsules are Nindanib or a placebo (inactive drug). 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).

Type of participant needed:

  • 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
Posted: May 10, 2016

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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

Company: GENENTECH
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.
Type of patient needed: 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.
Posted: August 28, 2014

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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)

Company: GENENTECH
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.
Type of patient needed: 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.
Posted: August 28, 2014

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ACOUSTICS

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

Company: GENENTECH, INC./ROCHE
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.
Type of patient needed: 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.
Posted: August 25, 2014

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

Company: GENENTECH, INC.
Clinical trial description: The phase II study (RIFF) is designed to evaluate the safety and efficacy of lebrikizumab in patients with idiopathic pulmonary fibrosis (IPF). The primary outcome measure for the study is Progression Free Survival.
Type of patient needed: 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.
Additional information:
Lebrikizumab is a monoclonal antibody that binds to and inhibits IL-13 activity.
Posted: October 10, 2013

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Disclaimer

The American College of Chest Physicians (CHEST), in furtherance of its mission of advancing research, has established this page to provide a list of clinical trials seeking individuals to serve as principal investigators or to otherwise participate. CHEST has neither conducted an independent investigation of the nature, quality, scientific merit, or subject matter of the clinical trials, nor has it established criteria or preconditions for those trials being listed on this page. CHEST, its officers, regents, members, and employees are not recommending or endorsing the listed trials or the companies sponsoring trials and specifically disclaims liability for damages of any kind arising out of a member, health-care provider, or any other individual’s participation in a listed trial.

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