NCT07907991Not yet recruitingPhase 3

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

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

Source: ClinicalTrials.gov · Last updated 30 Oct 2026

Brief summary (registry, in English)

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.

Status (registry): Not yet recruiting
Phase (registry): Phase 3
Study type: Interventional
Enrollment: 1800 (estimated)
First submitted: 23 Oct 2026
Start date: 10 Mar 2027
Primary completion date: 12 Dec 2029
Lead sponsor: Boehringer Ingelheim
Diseases: COPD
NCT number: NCT07907991
EU CT number: 2026-527805-39-00

What you commit to

Study type: Interventional · Phase 3
Planned participants: 1800
From 10 Mar 2027 to the primary completion date, 12 Dec 2029
No sites listed in no country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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
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.

Other illness

Clinically significant pulmonary disease other than COPD, e.g. sarcoidosis, interstitial lung disease, alpha-1 antitrypsin deficiency

Lab values

estimated Glomerular Filtration Rate (eGFR) according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula \<30 mL/min at screening

Other

Past or current diagnosis of bronchiectasis or bronchiectasis-COPD overlap as assessed by the investigator

Who the study is looking for

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.

Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.