Overview

A 52-week, Placebo-controlled Study to Evaluate the Efficacy and Safety of 2 Doses of CHF6001 DPI (Tanimilast), as add-on to Maintenance Triple Therapy in Subjects With COPD and Chronic Bronchitis (PILASTER)

Status:
Recruiting
Trial end date:
2024-09-01
Target enrollment:
0
Participant gender:
All
Summary
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.
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 chronic bronchitis

- Current or ex-smokers (history ≥ 10 pack years).

- Post-bronchodilator FEV1 <80% 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

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.

- 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