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 3TerminatedNCT04636814

Chiesi Farmaceutici S.p.A.3,973 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

3,973

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

CHF6001 1600µgDRUG

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

CHF6001 3200µgDRUG

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

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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.

Locations (460)

Outcomes

Primary Outcomes

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

Secondary Outcomes

The time to first moderate or severe exacerbation.

Time frame: Up to 52 weeks

The annual rate of severe exacerbations.

Time frame: Up to 52 weeks

The time to first severe exacerbation.

Time frame: Up to 52 weeks

The number of all on-treatment severe exacerbations.

Time frame: Up to 52 weeks

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.

Time frame: At week 52

Data from ClinicalTrials.gov

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\- 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

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

...and 450 more locations

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.

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.

Time frame: Up to 52 weeks

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 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 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 frame: Up to 52 weeks

Key Secondary Variable: Change from baseline in SGRQ Total score at week 52

Time frame: At week 52