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)

Conditions

• Chronic Obstructive Pulmonary Disease

Eligibility Criteria

Sex

ALL

Age

40 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• CHF6001 1600µg — DRUG
  CHF6001 400µg, 2 inhalations bid (total daily dose of 1600µg) and Roflumilast matching placebo, 1 tablet once daily
• CHF6001 3200µg — DRUG
  CHF6001 800µg, 2 inhalations bid (total daily dose of 3200µg) and Roflumilast matching placebo, 1 tablet once daily
• Placebo — DRUG
  CHF6001 matching placebo, 2 inhalations bid and Roflumilast matching placebo, 1 tablet once daily
• Roflumilast — DRUG
  \- 1 tablet of Roflumilast (Daliresp®), 250µg, once daily during the first 4 weeks of treatment then 1 tablet of Roflumilast (Daliresp®), 500µg, once daily for the remaining treatment period and CHF6001 matching placebo, 2 inhalations bid

Study Details

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.

Key Dates

Start date

Jul 12, 2021

Status verified

Jan 2026

Primary completion

Dec 23, 2025

Completion

Dec 23, 2025

Study Design

Enrollment

3,973 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: CHF6001 1600µg
• Experimental: CHF6001 3200µg
• Placebo Comparator: Placebo
• Active Comparator: Roflumilast

Primary Outcome Measure

The number of moderate and severe exacerbations occurring during the planned 52-week treatment period. [ Time Frame: Up to 52 weeks ]

Locations (150)

Find similar trials in Andalusia, AL

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