Overview

A 52-week, Placebo- and Active- Controlled (Roflumilast, Daliresp® 500µg) Study to Evaluate the Efficacy and Safety of Two Doses of CHF6001 DPI (Tanimilast) as add-on to Maintenance Triple Therapy in Subjects With COPD and Chronic Bronchitis. (PIL

Status:
Recruiting
Trial end date:
2024-09-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Chiesi Farmaceutici S.p.A.
Criteria
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.

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 COPD emphysema or mixed phenotypes.

- 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.