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)

Phase 3

Recruiting

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Drug: CHF6001 3200µg; Drug: Placebo; Drug: Roflumilast; Drug: CHF6001 1600µg

• Registration Number: NCT04636814
• Lead Sponsor: Chiesi Farmaceutici S.p.A.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-16
• Study First Submitted QC: 2020-11-16
• Study First Posted: 2020-11-19
• Study Start: 2021-07-12
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-12
• Primary Completion: 2027-04-03
• Study Completion: 2027-04-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3980

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CHF6001 3200µg	CHF6001 3200µg	-
Placebo	Placebo	-
Roflumilast	Roflumilast	-
CHF6001 1600µg	CHF6001 1600µg	-

Primary Outcome Measures

Name	Time	Method
The number of moderate and severe exacerbations occurring during the planned 52-week treatment period.	Up to 52 weeks	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

Secondary Outcome Measures

Name	Time	Method
Change from baseline to last inter-visit period (week 40-52) in EXACT-Respiratory Symptoms (E-RS) Total and subscale scores.	Up to 52 weeks	Change from baseline to last inter-visit period (week 40-52) in EXACT-Respiratory Symptoms (E-RS) Total and subscale scores.
E-RS response (change from baseline E-RS Total score ≤ -2) at week 52.	At week 52	E-RS response (change from baseline E-RS Total score ≤ -2) at week 52.
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.	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.
Key Secondary Variable: Change from baseline in SGRQ Total score at week 52	At week 52	Key Secondary Variable: Change from baseline in SGRQ Total score at week 52
The time to first moderate or severe exacerbation.	Up to 52 weeks	The time to first moderate or severe exacerbation.
The annual rate of severe exacerbations.	Up to 52 weeks	The annual rate of severe exacerbations.
The time to first severe exacerbation.	Up to 52 weeks	The time to first severe exacerbation.
The number of all on-treatment severe exacerbations.	Up to 52 weeks	The number of all on-treatment severe exacerbations.
Change from baseline (pre-dose Visit 2) in pre-dose FEV1, at week 52.	At week 52	Change from baseline (pre-dose Visit 2) in pre-dose FEV1, at week 52.
Change from baseline in Saint Georges Respiratory Questionnaire (SGRQ) total and domain scores at week 52.	At week 52	Change from baseline in Saint Georges Respiratory Questionnaire (SGRQ) total and domain scores at week 52.
The number of all on-treatment exacerbations requiring systemic corticosteroids.	Up to 52 weeks	The number of all on-treatment exacerbations requiring systemic corticosteroids.
Saint Georges Respiratory Questionnaire response (SGRQ) (change from baseline SGRQ total score ≤ -4) at week 52.	At week 52	Saint Georges Respiratory Questionnaire response (SGRQ) (change from baseline SGRQ total score ≤ -4) 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).	Up to 52 weeks	Change from baseline to last inter-visit period (week 40-52) in the percentage of days
Time to study medication discontinuation for any reason.	Up to 52 weeks	Time to study medication discontinuation for any reason.
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.	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.

Trial Locations

Locations (461)

Chiesi Clinical Trial - Site 840635; 🇺🇸 Andalusia, Alabama, United States

Chiesi Clinical Trial - Site 840614; 🇺🇸 Foley, Alabama, United States

Chiesi Clinical Trial - Site 840670; 🇺🇸 Guntersville, Alabama, United States

Chiesi Clinical Trial - Site 840720; 🇺🇸 Mobile, Alabama, United States

Chiesi Clinical Trial - Site 840643; 🇺🇸 Saraland, Alabama, United States

Chiesi Clinical Trial - Site 840638; 🇺🇸 Phoenix, Arizona, United States

Chiesi Clinical Trial - Site 840684; 🇺🇸 Conway, Arkansas, United States

Chiesi Clinical Trial - Site 840675; 🇺🇸 Laguna Hills, California, United States

Chiesi Clinical Trial - Site 840666; 🇺🇸 Los Angeles, California, United States

Chiesi Clinical Trial - Site 840511; 🇺🇸 Newport Beach, California, United States

Scroll for more (451 remaining)