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
Investigating the Effectiveness of an Investigational Medication for Chronic Obstructive Pulmonary Disease (COPD)
Sashank Kolli
Primary Investigator
Brief description of 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.
Detailed description of 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
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Age: 40 years - 100 years
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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.
This study investigates the effectiveness and safety of an investigational medication as an additional treatment for people with Chronic Obstructive Pulmonary Disease (COPD) and chronic bronchitis. COPD is a lung disease that makes it hard to breathe. The study will compare two doses of the investigational medication added to regular treatment with a placebo.
Participants will be randomly assigned to one of four study arms, including two different doses of the investigational medication, a placebo arm, and an active control arm. During the study, participants will continue their regular treatment and will have clinic visits and phone calls to monitor their health and the effects of the medication.
- Who can participate: Adults aged 40 and older with severe-to-very severe COPD and chronic bronchitis may participate. They must have a history of smoking, a specific lung function measure, and recent COPD exacerbations.
- Study details: Participants will be part of a study where they receive either the investigational medication or a placebo, which is an inactive substance that looks like the investigational medicine but does not contain any medicine. They will continue their regular treatment and attend clinic visits and phone calls for monitoring.
- Study timelines and visits: The study will last 52 weeks. The study requires 8 visits.
