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Evaluating CHF6001 as an add-on treatment for COPD and chronic bronchitis

A 52-week, Randomized, Double-blind, Double-dummy, Placebo- and Active- Controlled (Roflumilast, Daliresp® 500µg), Parallel Group, Study to Evaluate the Efficacy and Safety of Two Doses of CHF6001 DPI add-on to Maintenance Triple Therapy in Subjects With Chronic Obstructive Pulmonary Disease (COPD) and Chronic Bronchitis.

Phase 3 Interventional Chiesi Farmaceutici S.p.A. · NCT04636814

This study is testing if adding a new treatment called CHF6001 to the current medications can help adults with COPD and chronic bronchitis breathe better and have fewer flare-ups.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment3980 (estimated)
Ages40 Years and up
SexAll
SponsorChiesi Farmaceutici S.p.A. Industry-sponsored
Locations461 sites (Andalusia, Alabama and 460 other locations)
Trial IDNCT04636814 on ClinicalTrials.gov

What this trial studies

This study aims to assess the efficacy and safety of two doses of CHF6001 (Tanimilast) when added to existing maintenance triple therapy in adults with Chronic Obstructive Pulmonary Disease (COPD) and chronic bronchitis. Participants will receive either CHF6001, a placebo, or Roflumilast over a 52-week period. The study will focus on patients who have experienced at least one moderate or severe exacerbation in the past year and are currently on maintenance therapy. The goal is to determine if CHF6001 can improve respiratory function and reduce exacerbations in this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 40 and older with COPD and chronic bronchitis who have a history of smoking and are on maintenance triple therapy.

Not a fit: Patients with asthma, recent severe exacerbations, or other significant respiratory disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the management of COPD and chronic bronchitis, leading to better patient outcomes.

How similar studies have performed: Previous studies have shown promise with similar PDE4 inhibitors, suggesting potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion 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:

* 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.

Where this trial is running

Andalusia, Alabama and 460 other locations

+411 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Obstructive Pulmonary DiseaseCOPDchronic bronchitisPDE4 inhibitoranti-inflammatory respiratory drugTanimilast
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.