NCT04636814

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. (PILLAR)

About the 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.

Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION 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 prior to screening and receiving regular maintenance triple therapy for at least 3 months prior to screening visit.

EXCLUSION CRITERIA

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.