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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
4,710
CHF6001 400µg, 2 inhalations bid (total daily dose of 1600µg).
CHF6001 800µg, 2 inhalations bid (total daily dose of 3200µg).
CHF6001 matching placebo, 2 inhalations bid.
The number of moderate and severe COPD 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 corticosteroid (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.
Time frame: Up to 52 weeks
The annual rate of severe exacerbation.
Time frame: Up to 52 weeks
The time to first severe exacerbation.
Time frame: Up to 52 weeks
The number of on-treatment severe exacerbations.
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
Change from baseline in SGRQ total and domain scores at week 52.
Time frame: At week 52
SGRQ response (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 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.
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Chiesi Clinical Trial - Site 840402
Sheffield, Alabama, United States
Chiesi Clinical Trial - Site 840480
Northridge, California, United States
Chiesi Clinical Trial - Site 840487
Cutler Bay, Florida, United States
Chiesi Clinical Trial - Site 840404
Hollywood, Florida, United States
Chiesi Clinical Trial - Site 840407
Miami, Florida, United States
Chiesi Clinical Trial - Site 840444
Miami, Florida, United States
Chiesi Clinical Trial - Site 840437
Miami, Florida, United States
Chiesi Clinical Trial - Site 840403
Miami, Florida, United States
Chiesi Clinical Trial - Site 840463
Orlando, Florida, United States
Chiesi Clinical Trial - Site 840401
Peachtree Corners, Georgia, United States
...and 437 more locations
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)
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