Overview
The purpose of the study is to evaluate the efficacy and safety of two doses of CHF6001 (Tanimilast), as add-on to maintenance triple therapy in the target patient population.
Eligibility
Inclusion Criteria:
- Adults aged ≥ 40 years with COPD and chronic bronchitis
- Current or ex-smokers (history ≥ 10 pack years).
- Post-bronchodilator FEV1 <60% of the subject predicted normal value and FEV1/FVC ratio < 0.7.
- At least, one moderate or severe COPD exacerbation in 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 prior to study entry and randomization.
- Subjects with known α-1 antitrypsin deficiency as the underlying cause of COPD.
- Subjects with COPD emphysema or mixed phenotypes.
- Subjects with known respiratory disorders other than COPD.
- Subjects with active cancer or a history of lung cancer with full recovery less than 1 year after completing cancer therapy.
- 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.
- Subjects with a significant neurological disease.
- Subjects with clinically significant laboratory abnormalities.
- Subjects with moderate or severe hepatic impairment