A 52-week, Placebo-controlled Study to Evaluate the Efficacy and Safety of 2 Doses of CHF6001 DPI (Tanimilast), as add-on to Maintenance Triple Therapy in Subjects With COPD and Chronic Bronchitis (PILASTER)

Sponsor

Chiesi Farmaceutici S.p.A. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04636801

Collaborator

(none)

2,985

Enrollment

Location

Arms

37.6

Anticipated Duration (Months)

79.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to evaluate the efficacy and safety of two doses of CHF6001 (Tanimilast), as add-on to maintenance triple therapy in the target patient population.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease	Drug: Experimental: CHF6001 1600µg Drug: Experimental: CHF6001 3200µg Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

2985 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A 52-week, Randomized, Double-blind, Placebo-controlled, 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

Actual Study Start Date :

Jul 14, 2021

Anticipated Primary Completion Date :

Sep 1, 2024

Anticipated Study Completion Date :

Sep 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CHF6001 1600µg	Drug: Experimental: CHF6001 1600µg CHF6001 400µg, 2 inhalations bid (total daily dose of 1600µg).
Experimental: CHF6001 3200µg	Drug: Experimental: CHF6001 3200µg CHF6001 800µg, 2 inhalations bid (total daily dose of 3200µg).
Placebo Comparator: CHF6001 Placebo	Drug: Placebo CHF6001 matching placebo, 2 inhalations bid.

Arm

Intervention/Treatment

Experimental: CHF6001 1600µg

Drug: Experimental: CHF6001 1600µg

CHF6001 400µg, 2 inhalations bid (total daily dose of 1600µg).

Experimental: CHF6001 3200µg

Drug: Experimental: CHF6001 3200µg

CHF6001 800µg, 2 inhalations bid (total daily dose of 3200µg).

Placebo Comparator: CHF6001 Placebo

Drug: Placebo

CHF6001 matching placebo, 2 inhalations bid.

Outcome Measures

Primary Outcome Measures

The number of moderate and severe COPD 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 corticosteroid (oral/IV/IM corticosteroids), and/or use of antibiotics Severe: requiring hospitalisation or resulting in death

Secondary Outcome Measures

The time to first moderate or severe exacerbation. [Up to 52 weeks]
The annual rate of severe exacerbation. [Up to 52 weeks]
The time to first severe exacerbation. [Up to 52 weeks]
The number of on-treatment severe exacerbations. [Up to 52 weeks]
Change from baseline (pre-dose visit 2) in pre-dose FEV1 at week 52. [At Week 52]
Change from baseline in SGRQ total and domain scores at week 52. [At week 52]
SGRQ response (change from baseline SGRQ total score ≤ -4) at week 52. [At week 52]
Change from baseline to last inter-visit period (week 40-52) in E-RS Total and subscale scores [Up to 52 weeks]
E-RS response (change from baseline E-RS Total score ≤ -2) at week 52. [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]
Time to study medication discontinuation for any reason. [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. [Up to 52 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adults aged ≥ 40 years with COPD and chronic bronchitis
Current or ex-smokers (history ≥ 10 pack years).
Post-bronchodilator FEV1 <80% of the subject predicted normal value and FEV1/FVC ratio < 0.7.
At least, one moderate or severe COPD exacerbation in previous year.
CAT score >10
Subjects on regular maintenance triple therapy for at least 12 months

Exclusion Criteria:

Subjects with current asthma.
Subjects with moderate or severe COPD exacerbation 4 weeks prior to study entry and randomization.
Subjects with known α-1 antitrypsin deficiency as the underlying cause of COPD.
Subjects with COPD emphysema or mixed phenotypes.
Subjects with known respiratory disorders other than COPD.
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.
Subjects with a significant neurological disease.
Subjects with clinically significant laboratory abnormalities.
Subjects with moderate or severe hepatic impairment