A Phase 3 interventional study of CHF6001 1600µg and CHF6001 3200µg in Chronic Obstructive Pulmonary Disease, sponsored by Chiesi Farmaceutici S.p.A.. Terminated at 460 sites in 28 countries. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-02-02.
Sponsored by Chiesi Farmaceutici S.p.A. · Phase 3, Interventional, and Treatment
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.
209 studies on the registry are indexed under Bronchitis, Chronic; 14 are open to participants now.
This study's enrollment of 3,973 is above the median of 101 across 154 interventional studies indexed under Bronchitis, Chronic.
Browse Bronchitis, Chronic studies →Chiesi Farmaceutici S.p.A. is the lead sponsor of 185 studies on the registry; 22 are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 11 (61%) have results posted.
Compared within Bronchitis, Chronic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Pulmonary Disease, Chronic Obstructive. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: CHF6001 1600µg
Drug: CHF6001 3200µg
Drug: Placebo
Drug: Roflumilast
CHF6001 400µg, 2 inhalations bid (total daily dose of 1600µg) and Roflumilast matching placebo, 1 tablet once daily
CHF6001 800µg, 2 inhalations bid (total daily dose of 3200µg) and Roflumilast matching placebo, 1 tablet once daily
CHF6001 matching placebo, 2 inhalations bid and Roflumilast matching placebo, 1 tablet once daily
\- 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
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
Time frame: Up to 52 weeks
The time to first moderate or severe exacerbation.
The time to first moderate or severe exacerbation.
Time frame: Up to 52 weeks
The annual rate of severe exacerbations.
The annual rate of severe exacerbations.
Time frame: Up to 52 weeks
The time to first severe exacerbation.
The time to first severe exacerbation.
Time frame: Up to 52 weeks
The number of all on-treatment severe exacerbations.
The number of all on-treatment severe exacerbations.
Time frame: Up to 52 weeks
The number of all on-treatment exacerbations requiring systemic corticosteroids.
The number of all on-treatment exacerbations requiring systemic corticosteroids.
Time frame: Up to 52 weeks
Change from baseline (pre-dose Visit 2) in pre-dose FEV1, at week 52.
Change from baseline (pre-dose Visit 2) in pre-dose FEV1, at week 52.
Time frame: At week 52
Change from baseline in Saint Georges Respiratory Questionnaire (SGRQ) total and domain scores at week 52.
Change from baseline in Saint Georges Respiratory Questionnaire (SGRQ) total and domain scores at week 52.
Time frame: At week 52
Saint Georges Respiratory Questionnaire response (SGRQ) (change from baseline SGRQ total score ≤ -4) at week 52.
Saint Georges Respiratory Questionnaire response (SGRQ) (change from baseline SGRQ total score ≤ -4) at week 52.
Time frame: At week 52
Change from baseline to last inter-visit period (week 40-52) in EXACT-Respiratory Symptoms (E-RS) Total and subscale scores.
Change from baseline to last inter-visit period (week 40-52) in EXACT-Respiratory Symptoms (E-RS) Total and subscale scores.
Time frame: Up to 52 weeks
E-RS response (change from baseline E-RS Total score ≤ -2) at week 52.
E-RS response (change from baseline E-RS Total score ≤ -2) at week 52.
Time frame: At week 52
Change from baseline to last inter-visit period (week 40-52) in the percentage of days without intake of rescue medication and in the average rescue medication use (number of puffs).
Change from baseline to last inter-visit period (week 40-52) in the percentage of days
Time frame: Up to 52 weeks
Time to study medication discontinuation for any reason.
Time to study medication discontinuation for any reason.
Time frame: Up to 52 weeks
Time to moderate or severe exacerbation or study medication discontinuation due to any adverse event, lack of efficacy or death (composite endpoint) and time to study medication discontinuation component.
Time to moderate or severe exacerbation or study medication discontinuation due to any adverse event, lack of efficacy or death (composite endpoint) and time to study medication discontinuation component.
Time frame: Up to 52 weeks
Time to first moderate/severe exacerbation or study medication discontinuation due to any class-related AE, lack of efficacy, or death (composite endpoint) and time to study medication discontinuation component.
Time to first moderate/severe exacerbation or study medication discontinuation due to any class-related AE, lack of efficacy, or death (composite endpoint) and time to study medication discontinuation component.
Time frame: Up to 52 weeks
Key Secondary Variable: Change from baseline in SGRQ Total score at week 52
Key Secondary Variable: Change from baseline in SGRQ Total score at week 52
Time frame: At week 52
Showing the first 100 of 460 sites across 28 countries. Choose a country and city above to see the rest.
Plan to share: No
No publications or documents are linked to this record.
Ran from Jul 2021 to primary completion in Dec 2025, 53 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Tanimilast