NCT04636814TerminatedPhase 3
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.
Chiesi Farmaceutici S.p.A.609 sites in 1 country3,973 target enrollmentStarted: July 12, 2021Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- Chiesi Farmaceutici S.p.A.
- Enrollment
- 3,973
- Locations
- 609
- Primary Endpoint
- The number of moderate and severe exacerbations occurring during the planned 52-week treatment period.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •At least, one moderate or severe COPD exacerbation in the previous year.
- •CAT score ≥
- •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.
Arms & Interventions
CHF6001 3200µg
Experimental
Intervention: CHF6001 3200µg (Drug)
CHF6001 1600µg
Experimental
Intervention: CHF6001 1600µg (Drug)
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
Roflumilast
Active Comparator
Intervention: Roflumilast (Drug)
Outcomes
Primary Outcomes
The number of moderate and severe exacerbations occurring during the planned 52-week treatment period.
Time Frame: 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 Outcomes
- 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)
- E-RS response (change from baseline E-RS Total score ≤ -2) at week 52.(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)
- Key Secondary Variable: Change from baseline in SGRQ Total score at week 52(At week 52)
- Saint Georges Respiratory Questionnaire response (SGRQ) (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 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 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)
- The time to first moderate or severe exacerbation.(Up to 52 weeks)
- The annual rate of severe exacerbations.(Up to 52 weeks)
- The time to first severe exacerbation.(Up to 52 weeks)
- The number of all 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 Saint Georges Respiratory Questionnaire (SGRQ) total and domain scores at week 52.(At week 52)
- The number of all on-treatment exacerbations requiring systemic corticosteroids.(Up to 52 weeks)
Investigators
Study Sites (609)
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