CHEST Clinical Trials Opportunities

Sponsoring company: Regeneron Pharmaceuticals
Disease state: asthma

AIM4: Next Step is a clinical research study for patients with uncontrolled asthma with the aim of assessing whether it’s more effective to use a study drug together with an inhaled asthma medication or to take a higher dose of the inhaled asthma medication on its own. The study will enroll approximately 250 individuals with asthma across North America and Europe.

CLINICALTRIALS.GOV LINK »

STUDY LINK »

Sponsoring company: United Therapeutics Corporation
Disease state: pulmonary fibrosis, interstitial lung disease

This Phase 3, multinational, randomized, double-blind, placebo-controlled study evaluates the safety and efficacy of inhaled treprostinil in subjects with PPF over 52 weeks. Subjects will be randomly allocated 1:1 to receive inhaled treprostinil or placebo, starting at a dose of 3 breaths administered 4 times daily (QID) and titrating to a target dosing regimen of 12 breaths QID. Six Treatment visits to the clinic are required at Weeks 4, 8, 16, 28, 40, and 52.

Efficacy assessments include spirometry, time to clinical worsening, time to first acute exacerbation of ILD, overall survival, King's Brief Interstitial Lung Disease (K-BILD) questionnaire, plasma NT-proBNP, supplemental oxygen use, and lung diffusion capacity. Safety assessments include adverse events /serious adverse events, vital signs, clinical laboratory parameters, and electrocardiogram parameters.

Subjects completing the Week 52 Visit may be offered entry to an open-label extension study, following the final study visit.

CLINICALTRIALS.GOV LINK »

Sponsoring company: United Therapeutics Corporation
Disease states: interstitial lung disease, pulmonary hypertension, pulmonary hypertension associated with interstitial lung disease

This study aims to observe and capture demographic characteristics, treatment patterns, and clinical outcomes for patients with PH-ILD to enhance understanding of the disease and treatment.

Patients will be enrolled into 1 of 3 cohorts: approximately 500 patients not receiving inhaled treprostinil, 150 patients newly initiated on Tyvaso/Tyvaso DPI, and 350 patients receiving Tyvaso/Tyvaso DPI for >60 days.

Data collection will occur every 6- or 12 months unless the data is available via standard of care, following patients for up to 5 years.

Assessments include pulmonary function tests including diffusing capacity of the lungs for carbon monoxide; high resolution computed tomography; vital signs; 6-Minute Walk Test; blood draw for plasma N-terminal pro-BNP concentration, genetics analysis, biomarker analysis; echocardiography; EuroQoL 5 Dimension 5 Level Questionnaire; King's Brief ILD Questionnaire; Living with PF Questionnaire; Therapy Administration Questionnaire; healthcare resource utilization; current medications and rehabilitation; WHO functional class; transplant status; survival data; and RHC.

CLINICALTRIALS.GOV LINK »

Sponsoring company: Boehringer Ingelheim Pharmaceuticals, Inc.
Disease states: idiopathic pulmonary fibrosis

A double-blind, randomized, placebo-controlled, parallel group, phase 2a trial to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of BI 765423 administered intravenously with or without standard of care in patients with idiopathic pulmonary fibrosis.

CLINICALTRIALS.GOV LINK »

STUDY LINK »

Sponsoring company: Boehringer Ingelheim Pharmaceuticals, Inc.
Disease states: interstitial lung disease, idiopathic pulmonary fibrosis

A double-blind, randomized, placebo-controlled exploratory trial to investigate the efficacy and safety of Nerandomilast over 24 months when administered in individuals with interstitial lung abnormalities and a family history of pulmonary fibrosis to reduce the risk of worsening (DROP-FPF).

CLINICALTRIALS.GOV LINK »

Sponsoring company: Sanofi
Disease states: COPD

AEOLUS is a phase IV clinical study for adults with moderate to severe chronic obstructive pulmonary disease (COPD) who show evidence of type 2 inflammation. The study aims to evaluate the effect of dupilumab compared with placebo on airway inflammation, resistance, and remodeling, including mucus plugging, and to explore how these changes relate to improvements in lung function, exacerbations, and quality of life. Approximately 218 participants will be enrolled across multiple international centers. Eligible participants are adults aged 40–85 with moderate to severe COPD, signs of type 2 inflammation (high blood eosinophils), and mucus blockages visible on CT scans.

CLINICALTRIALS.GOV LINK »

Sponsoring company: Boehringer Ingelheim Pharmaceuticals, Inc.
Disease state: bronchiectasis, cystic fibrosis bronchiectasis, non-cystic fibrosis bronchiectasis

A phase III, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of BI 1291583 2.5mg administered once daily for up to 76 weeks in patients with bronchiectasis.

CLINICALTRIALS.GOV LINK »

STUDY LINK »

Sponsoring company: Avalyn Pharma
Disease state: progressive pulmonary fibrosis

The 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 (PPF). This randomized, double-blind, placebo-controlled study is expected to enroll approximately 300 individuals with PPF 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 will also be evaluated.

This clinical research study is for adults age 18 and older with PPF, who show worsening symptoms and/or decline in lung function. Patients can be on background immunosuppressants or oral nintedanib.

CLINICALTRIALS.GOV LINK »

STUDY LINK »

Sponsoring company: Boehringer Ingelheim Pharmaceuticals, Inc
Disease state: interstitial lung disease, systemic autoimmune rheumatic diseases associated with interstitial lung disease

A double blind, randomized, placebo-controlled trial evaluating the efficacy and safety of nerandomilast over at least 26 weeks in patients with systemic autoimmune rheumatic diseases associated interstitial lung diseases.

CLINICALTRIALS.GOV LINK »

Sponsoring company: GSK
Disease state: COPD

A randomized, double-blind, placebo-controlled, parallel-group, multicenter study of the efficacy and safety of depemokimab in adult participants with COPD with type 2 inflammation.

CLINICALTRIALS.GOV LINK »

Sponsoring company: GSK
Disease state: refractory chronic cough

This is a randomized, double-blind, placebo-controlled, parallel-arm, phase 3 study of BLU-5937 in participants with refractory chronic cough (RCC).

CLINICALTRIALS.GOV LINK »

Sponsoring company: Bristol Myers Squibb
Disease state: pulmonary fibrosis

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.

CLINICALTRIALS.GOV LINK »

STUDY LINK »