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NCT07907991

PHASE3

The AIRWARD Study: A Study to Test Whether Verducatib Helps People With Chronic Obstructive Pulmonary Disease

Sponsor: Boehringer Ingelheim

View on ClinicalTrials.gov

Summary

This study is open to adults aged 40 years and older who have chronic obstructive pulmonary disease (COPD) with ongoing symptoms. People can join the study if they are at risk of COPD flare-ups (also called acute exacerbations or sudden worsening of COPD symptoms) even though they use their usual inhaled or oral COPD medicines. They must have had at least 2 moderate COPD flare-ups or at least 1 severe COPD flare-up in the past year, including at least 1 while taking their current COPD treatment. People must also have a blood test result showing less than 300 eosinophils (a type of white blood cell) per microliter. The purpose of this study is to find out whether a medicine called verducatib helps people with COPD have fewer flare-ups or sudden worsening of COPD symptoms over up to about 1.5 years, compared with placebo. The study also looks at whether verducatib delays the time until the first flare-up, how well it is tolerated, improves participants' quality of life, and improves their lung function when compared with placebo. In this study, participants are put into 2 groups randomly, which means by chance. One group takes verducatib as tablets and the other group takes placebo tablets. Placebo tablets look like verducatib tablets but do not contain any medicine. Participants take a tablet by mouth once a day for at least 1 year and up to about 1.5 years. All participants continue their regular COPD treatment during the study. Participants are in the study for at least 1 year and up to about 1 year and 8 months. During this time, they have regular visits at the study site and monthly phone calls from the study staff to check on their COPD symptoms and any health problems. Doctors collect information about participants' health, including blood samples. They record how often participants have moderate or severe COPD flare-ups and how long it takes until the first flare-up. They also measure lung function and ask participants to fill in questionnaires about their symptoms and daily life. Participants have to daily report their symptoms and intake of certain medications in an electronic diary at home. The results are compared between the 2 groups to see whether verducatib helps reduce flare-ups and improves symptoms. The doctors also regularly check participants' health and note any unwanted effects.

Official title: The AIRWARD Study: A Phase III, Double-blind, Randomised, Placebo-controlled, Multicentre Trial to Evaluate the Efficacy and Safety of Verducatib in Participants With COPD

Key Details

Gender

All

Age Range

40 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1800

Start Date

2027-03-10

Completion Date

2030-01-09

Last Updated

2026-10-30

Healthy Volunteers

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

DRUG

Verducatib

DRUG

Placebo matching verducatib

Inclusion Criteria: * Age ≥40 years * Diagnosis of chronic obstructive pulmonary disease (COPD) for at least 12 months prior to screening according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) definition * Post-bronchodilator (BD) forced expiratory volume in 1 second (FEV1)/forced vital capacity \[FVC\] \<0.70 at screening and baseline * Post-BD forced expiratory volume in 1 second percent predicted (FEV1pp) ≥30% at screening * Current or former cigarette smokers with a smoking history ≥10 pack years history of cigarette smoking * Chronic Airways Disease Assessment Test (CAAT) score ≥10 at screening with cough and sputum sub-scores of ≥ 2 * Documented history of ≥2 moderate or ≥1 severe exacerbations within 12 months prior to screening. At least one exacerbation must have occurred while participants were on their current COPD maintenance therapy * Stable standard of care considered appropriate by the investigator for at least 3 months prior to screening with either * Triple therapy Long-acting beta agonist (LABA) + Long-acting muscarinic antagonist (LAMA) + Inhaled corticosteroid (ICS) * Double therapy LAMA+LABA Additional medications, e.g. as per local COPD guidelines should also be stable for at least 3 months * Blood eosinophil count \<300 cells/µL at screening Further inclusion criteria apply. Exclusion Criteria: * Current diagnosis of asthma, prior history of asthma, or asthma-COPD overlap. Childhood history of asthma is allowed and defined as asthma diagnosed and resolved before the age of 18 * Clinically significant pulmonary disease other than COPD, e.g. sarcoidosis, interstitial lung disease, alpha-1 antitrypsin deficiency * Past or current diagnosis of bronchiectasis or bronchiectasis-COPD overlap as assessed by the investigator * estimated Glomerular Filtration Rate (eGFR) according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula \<30 mL/min at screening * Upper and lower respiratory tract infection within 4 weeks prior to screening or during the screening and randomisation period * Participants with bronchoscopic interventional procedures up to 3 years prior to screening * Prior history of or planned pneumonectomy or lung volume reduction surgery. * Participants who are participating in the acute phase of a pulmonary rehabilitation or smoking-cessation program, i.e. who started such program \< 4 weeks prior screening * Moderate or severe Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) within 4 weeks prior to screening or between screening and randomisation Further exclusion criteria apply.

Clinical Research Directory

The AIRWARD Study: A Study to Test Whether Verducatib Helps People With Chronic Obstructive Pulmonary Disease

Summary

Key Details

Conditions

Interventions

Eligibility Criteria