Verducatib for Chronic Obstructive Pulmonary Disease

Not yet recruiting at 25 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Boehringer Ingelheim
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for adults aged 40 and older who have COPD with ongoing symptoms, are current or former smokers (at least 10 years), have had at least 2 moderate or 1 severe COPD flare-up in the past year despite regular treatment, and meet certain lung function and blood test criteria.

Inclusion Criteria

I am 40 years old or older.
I am using LABA, LAMA, and ICS inhalers together for my condition.
I have been on stable LAMA+LABA therapy and other COPD meds for at least 3 months.
See 7 more

What Are the Treatments Tested in This Trial?

Interventions

  • Verducatib

Trial Overview

The study tests whether a daily tablet of verducatib helps reduce COPD flare-ups compared to a placebo. Participants continue their usual COPD medicines and are randomly assigned to either verducatib or placebo for up to about 1.5 years.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Verducatib treatment groupExperimental Treatment1 Intervention
Group II: Placebo groupPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials
2,566
Recruited
16,150,000+