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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)

NCT04636814 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3973

Last updated 2026-02-02

No results posted yet for this study

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.

Conditions

Interventions

DRUG

CHF6001 1600µg

CHF6001 400µg, 2 inhalations bid (total daily dose of 1600µg) and Roflumilast matching placebo, 1 tablet once daily

DRUG

CHF6001 3200µg

CHF6001 800µg, 2 inhalations bid (total daily dose of 3200µg) and Roflumilast matching placebo, 1 tablet once daily

DRUG

Placebo

CHF6001 matching placebo, 2 inhalations bid and Roflumilast matching placebo, 1 tablet once daily

DRUG

Roflumilast

\- 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

Sponsors & Collaborators

  • Chiesi Farmaceutici S.p.A.

    lead INDUSTRY

Principal Investigators

  • Fernando J. MARTINEZ, Prof. · Weill Cornell Medical College, New York Presbyterian Hospital, 1305 York avenue box 96 NY 10021 USA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-12
Primary Completion
2025-12-23
Completion
2025-12-23
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Austria
  • Bosnia and Herzegovina
  • Bulgaria
  • Chile
  • Croatia
  • Czechia
  • Estonia
  • Germany
  • Greece
  • Hungary
  • Israel
  • Latvia
  • Mexico
  • Netherlands
  • New Zealand
  • North Macedonia
  • Poland
  • Romania
  • Russia
  • Serbia
  • Slovakia
  • South Korea
  • Spain
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04636814 on ClinicalTrials.gov