A Phase 3 interventional study of Verducatib and Placebo matching verducatib in Chronic Obstructive Pulmonary Disease, sponsored by Boehringer Ingelheim. Not yet recruiting. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Boehringer Ingelheim · Phase 3, Interventional, and Treatment
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.
4,263 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 714 are open to participants now.
This study's planned enrollment of 1,800 is above the median of 70 across 3,016 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Boehringer Ingelheim is the lead sponsor of 2,300 studies on the registry; 59 are open to participants now.
Of its 167 completed or terminated interventional studies of FDA-regulated products, 123 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Stable standard of care considered appropriate by the investigator for at least 3 months prior to screening with either
Exclusion Criteria:
Drug: Verducatib
Drug: Placebo matching verducatib
Verducatib
Placebo matching verducatib
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
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
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).
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
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.
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
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.
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
No study locations are listed for this record.
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
Access criteria: For study documents - upon signing of a "Document Sharing Agreement". For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
Data sharing details ↗ · www.clinicalstudies.boehringer-ingelheim.com
Start is estimated for Mar 2027; primary completion for Dec 2029, 33 months later.
Of 91 industry-sponsored phase 3 interventional studies under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 43. This study's planned 33 months is above that.
Counting every sponsor, half of 119 studies reached it within 25 months; a quarter within 15 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Verducatib
Pulmonary Disease, Chronic Obstructive →