A 52-week, randomized, double-blind, double-dummy, placebo- andactive- controlled (Roflumilast, Daliresp® 500micograms), parallel group, studyto evaluate the efficacy and safety of two doses of CHF6001 DPI addonto maintenance triple therapy in subjects with Chronic ObstructivePulmonary Disease (COPD) and chronic bronchitis
S
Sashank Kolli
Primary Investigator
Enrolling By Invitation
40 years - 100 years
All
Phase
3
1 participants needed
1 Location
Brief description of study
What is the purpose of this study?
The purpose of this study is to evaluate the efficacy and the safety of two doses of CHF6001 (Tanimilast) as add-on to maintenance triple therapy in the target patient population.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Severe-to-very severe COPD patients with chronic bronchitis, on regular maintenance triple therapy and a documented history of at least one moderate or severe COPD exacerbation in the previous year will be identified and contacted directly by the research team about study participation.
Detailed description of study
What will happen during the study?
- This is a phase III, randomized, double-blind, double-dummy, placebo and active-controlled, 4-arm parallel group study to evaluate the efficacy of two doses of CHF6001 add-on to maintenance triple therapy (free or fixed
combination of ICS, LABA, LAMA) to reduce the rate of moderate and severe exacerbations after
52 weeks of treatment in comparison with maintenance triple therapy (i.e. placebo arm). - Approximately 3980 subjects will be randomized in approximately 450 sites.
- The study entails three periods: a run-in period of 2-week duration, a treatment period of 52 weeks duration, and a post-treatment follow-up period of 1 week ±2 days.
- A total of 8 clinic visits (V0 to V7) as well as 2 phone calls will be performed during the study.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Chronic Obstructive Pulmonary Disease, COPD, Chronic Bronchitis
-
Age: 40 years - 100 years
-
Gender: All
Inclusion Criteria:
- Adults aged ≥ 40 years, with COPD and with chronic bronchitis.
- Current smokers or ex-smokers (history of ≥10 pack years).
- Post-bronchodilator FEV1 <50% of the patient predicted normal value and FEV1/FVC ratio < 0.7.
- At least, one moderate or severe COPD exacerbation in the previous year.
- CAT score ≥10.
- Subjects on regular maintenance triple therapy for at least 12 months prior to screening and receiving regular maintenance triple therapy for at least 3 months prior to screening visit.
Exclusion Criteria:
- Subjects with current asthma.
- Subjects with moderate or severe COPD exacerbation 4 weeks before study entry and randomisation
- Subjects with known α-1 antitrypsin deficiency as the underlying cause of COPD.
- Subjects with primary diagnosis of emphysema not related to COPD.
- Subjects with known respiratory disorders other than COPD.
- Subjects with lung volume reduction surgery.
- Subjects with active cancer or a history of lung cancer.
- Subjects under Roflumilast treatment within 6 months before study entry.
- Subjects with a diagnosis of depression, generalised anxiety disorder, suicidal ideation.
- Subjects with clinically significant cardiovascular condition.
- Subjects with neurological disease.
- Subjects with clinically significant laboratory abnormalities.
- Subjects with moderate or severe hepatic impairment.
Updated on
20 Mar 2025.
Study ID: BALL-CF-PILLAR, 26077
Please visit our main page to search for other studies you may be interested in.
If you need help finding a study or have any questions, please contact us at inhealth@iu.edu
