A 52-week, randomised, double blind, multicentre, 2-arm parallel group trial assessing the efficacy and safety of CHF6001 (total daily dose 3200 μg) Dry Powder Inhaler (DPI) add-on to maintenance medium or high dose inhaled corticosteroid in combination with long-acting ß2-agonists in subjects with uncontrolled asthma

Conditions

Asthma

Brief summary

Number of asthma exacerbations over the 52-week study period.

Detailed description

Time to first asthma exacerbation, Number of asthma exacerbation and asthma worsening over 52 weeks of treatment;, Time to first asthma exacerbation or asthma worsening, ACQ-7 responders at Week 4, Week 26 and Week 52 (i.e., subjects showing improvement from baseline in ACQ-7 score of ≥0.5 units), Change from baseline in ACQ-7 and ACQ-6 (i.e. average of the first 6 items of the ACQ-7 questionnaire) score at Week 4, Week 26 and Week 52, Change from baseline in Mini-AQLQ at Week 4, Week 26 and Week 52, Change from baseline in pre-dose FEV1 at Week 4, Week 26 and Week 52, Change from baseline in pre-dose FVC at Week4, Week 52 and Week 26, Change from baseline (run-in period) to each inter-visit period and to the entire treatment period in pre dose morning/evening PEF, Change from baseline to each inter-visit period and to the entire treatment period in the average rescue medication use (number of puffs/day) and asthma symptoms score, Change from baseline to each inter-visit period and to the entire treatment period in the percentage of rescue medication-free days, asthma symptoms-free days and asthma control days

Related papers

No related papers found yet.

Interventions

DRUGCHF6001 matching placebo

DRUGCHF6001 DPI

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Number of asthma exacerbations over the 52-week study period.	—

Secondary

Measure	Time frame
Time to first asthma exacerbation, Number of asthma exacerbation and asthma worsening over 52 weeks of treatment;, Time to first asthma exacerbation or asthma worsening, ACQ-7 responders at Week 4, Week 26 and Week 52 (i.e., subjects showing improvement from baseline in ACQ-7 score of ≥0.5 units), Change from baseline in ACQ-7 and ACQ-6 (i.e. average of the first 6 items of the ACQ-7 questionnaire) score at Week 4, Week 26 and Week 52, Change from baseline in Mini-AQLQ at Week 4, Week 26 and Week 52, Change from baseline in pre-dose FEV1 at Week 4, Week 26 and Week 52, Change from baseline in pre-dose FVC at Week4, Week 52 and Week 26, Change from baseline (run-in period) to each inter-visit period and to the entire treatment period in pre dose morning/evening PEF, Change from baseline to each inter-visit period and to the entire treatment period in the average rescue medication use (number of puffs/day) and asthma symptoms score, Change from baseline to each inter-visit period and to	—

Measure

Time frame

Time to first asthma exacerbation, Number of asthma exacerbation and asthma worsening over 52 weeks of treatment;, Time to first asthma exacerbation or asthma worsening, ACQ-7 responders at Week 4, Week 26 and Week 52 (i.e., subjects showing improvement from baseline in ACQ-7 score of ≥0.5 units), Change from baseline in ACQ-7 and ACQ-6 (i.e. average of the first 6 items of the ACQ-7 questionnaire) score at Week 4, Week 26 and Week 52, Change from baseline in Mini-AQLQ at Week 4, Week 26 and Week 52, Change from baseline in pre-dose FEV1 at Week 4, Week 26 and Week 52, Change from baseline in pre-dose FVC at Week4, Week 52 and Week 26, Change from baseline (run-in period) to each inter-visit period and to the entire treatment period in pre dose morning/evening PEF, Change from baseline to each inter-visit period and to the entire treatment period in the average rescue medication use (number of puffs/day) and asthma symptoms score, Change from baseline to each inter-visit period and to

—

Countries

Bulgaria, Czechia, Germany, Hungary, Italy, Latvia, Lithuania, Poland, Romania, Spain

Outcome results

None listed