Chronic Obstructive Pulmonary DiseasePhase 3NCT07907991
The AIRWARD Study: A Study to Test Whether Verducatib Helps People With Chronic Obstructive Pulmonary Disease
A Phase 3 study testing Verducatib in people with Chronic Obstructive Pulmonary Disease, run by Boehringer Ingelheim.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Verducatib
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,800 participants
- Where
- No sites listed yet
- Study dates
- 10 Mar 2027to 9 Jan 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Verducatib, Placebo matching verducatib
- Keywords
- exacerbations
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VerducatibDrug
Verducatib
Placebo matching verducatibDrug
Placebo matching verducatib
| Study group | Role | What they receive |
|---|---|---|
| Verducatib treatment group | Experimental | Not described Receives: Drug: Verducatib |
| Placebo group | Placebo comparator | Not described Receives: Drug: Placebo matching verducatib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annualised rate of moderate or severe acute exacerbation of chronic obstructive pulmonary disease (AECOPD) (number of events per person per year)
Measured: Up to week 76
Secondary outcomes (9)
Time to first moderate or severe AECOPD
Measured: Up to week 76
Time to first severe AECOPD
Measured: Up to week 76
Achievement of St George's Respiratory Questionnaire (SGRQ) response (decrease in total score by ≥4 points from baseline) at week 52
SGRQ consists of 50 items covering symptoms, activity and impacts on daily life with varying response options (3 to 5-point Likert scales, dichotomous response option). Domain scores as well as a global score are generated ranging from 0 to 100, with lower scores indicating better health related Quality of Life (QoL).
Measured: At baseline and at week 52
Absolute change from baseline in post-Bronchodilator (BD) forced expiratory volume in 1 second (FEV1) (milliliters) at week 52
Measured: At baseline and at week 52
Annualised rate of severe AECOPD
Measured: Up to week 76
Absolute change from baseline in SGRQ total score at week 52
Measured: At baseline and at week 52
Achievement of Evaluating Respiratory Symptoms E-RS: COPD response (decrease by ≥2 points from baseline) at week 52
E-RS:COPD is an 11-item respiratory symptom score derived from the 14-item Exacerbations of chronic pulmonary disease tool (EXACT)-COPD diary and is used to assess the severity of daily respiratory symptoms in patients with stable COPD. It covers exacerbation-related symptoms breathlessness (5 items), cough and sputum (3 items), and chest symptoms (3 items). These items sum up to a total score ranging from 0 to 40, with higher scores indicating higher symptom severity.
Measured: At baseline and at week 52
Achievement of Chronic Airways Disease Assessment Test (CAAT) response (decrease by ≥2 points from baseline) at week 52
CAAT is designed to measure health status impairment in chronic airways disease; it consists of 8 unidimensional items with scores ranging from 0 to 5 (0 = no impairment). The total score ranges from 0 - 40 with a higher score indicating a worse health status of the patient.
Measured: At baseline and at week 52
Absolute change from baseline in post-BD Forced expiratory volume in 1 second percent predicted (FEV1pp) at week 52
Measured: At baseline and at week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start10 Mar 2027 (estimated)
- Primary completion12 Dec 2029 (estimated)
- Study completion9 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07907991
- Sponsor's protocol ID
- 1397-0047
- Other IDs
- 2026-527805-39-00, U1111-1345-6424
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined on the website.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07907991
- Acronym / sponsor ID
- 1397-0047
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- exacerbations
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 10 Mar 2027 (estimated)
- Primary completion
- 12 Dec 2029 (estimated)
- Study completion
- 9 Jan 2030 (estimated)
- First posted
- 30 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verducatib treatment group | Experimental | Drug: Verducatib |
| Placebo group | Placebo comparator | Drug: Placebo matching verducatib |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VerducatibVerducatib | Drug | Verducatib treatment group |
| Placebo matching verducatibPlacebo matching verducatib | Drug | Placebo group |
Primary outcome
Annualised rate of moderate or severe acute exacerbation of chronic obstructive pulmonary disease (AECOPD) (number of events per person per year)
Time frame: Up to week 76
9 secondary outcomes
Time to first moderate or severe AECOPD
Time frame: Up to week 76
Time to first severe AECOPD
Time frame: Up to week 76
Achievement of St George's Respiratory Questionnaire (SGRQ) response (decrease in total score by ≥4 points from baseline) at week 52
Time frame: At baseline and at week 52
Absolute change from baseline in post-Bronchodilator (BD) forced expiratory volume in 1 second (FEV1) (milliliters) at week 52
Time frame: At baseline and at week 52
Annualised rate of severe AECOPD
Time frame: Up to week 76
Absolute change from baseline in SGRQ total score at week 52
Time frame: At baseline and at week 52
Achievement of Evaluating Respiratory Symptoms E-RS: COPD response (decrease by ≥2 points from baseline) at week 52
Time frame: At baseline and at week 52
Achievement of Chronic Airways Disease Assessment Test (CAAT) response (decrease by ≥2 points from baseline) at week 52
Time frame: At baseline and at week 52
Absolute change from baseline in post-BD Forced expiratory volume in 1 second percent predicted (FEV1pp) at week 52
Time frame: At baseline and at week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined on the website.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Verducatib in people with Chronic Obstructive Pulmonary Disease, run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Boehringer Ingelheim (018002430127, clintriage.rdg@boehringer-ingelheim.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annualised rate of moderate or severe acute exacerbation of chronic obstructive pulmonary disease (AECOPD) (number of events per person per year) (time frame: Up to week 76). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.