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)

The research company Chiesi Farmaceutici S.p.A is conducting the clinical trial 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).

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.

It is planned to include 3980 participants.

Actual study start date is June 2021. The researchers expect to complete the study by September 2024.

One primary outcome measure is The number of moderate and severe exacerbations occurring during the planned 52-week treatment period, Moderate or severe exacerbation is defined by symptomatic worsening of COPD: Moderate: requiring use of systemic corticosteroids (oral/IV/IM corticosteroids), and/or use of antibiotics; Severe: requiring hospitalisation or resulting in death.

The inclusion criteria are:  

- 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.

Among the exclusion criteria are:

- 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.

The location of the study is as follows (further details can be found here): https://ichgcp.net/clinical-trials-registry/NCT04636814