The purpose of this phase III Study is to demonstrate the efficacy of at least one dose of CHF 6532 on moderate and severe asthma exacerbations rate compared to placebo.
This is a phase III, randomised, double-blind, placebo controlled multinational, multicentre, 4-arm parallel-group, study evaluating 3 doses of CHF 6532. The effect of CHF 6532 compared to Placebo on severe asthma exacerbations over 52 weeks of treatment will be assessed. The effect of CHF 6532 compared to Placebo in terms of change from baseline in pre-dose morning Forced Expiratory Volume in the first second (FEV1) as well as on St. George's Respiratory Questionnaire (SGRQ), Asthma Control Questionnaire (ACQ-5) and Asthma Quality of Life Questionnaire (AQLQ+12), at Week 52 will be assessed . The inter-subject variability in the drug exposure and the effect of selected covariates on Pharmacokinetics (PK) will be investigated. The impact of study treatments on health economics outcomes will be also investigated. Standard safety assessments will be conducted during the Study, including electrocardiograms (ECGs), vital signs and laboratory tests. Approximately 1392 severe eosinophilic asthmatic adult subjects and additional 248 severe eosinophilic asthmatic adolescent subjects will be randomised in about 150 investigational sites.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
810
Medical Center "Nov Rehabilitatsionen Tsentar" Ltd
Stara Zagora, Bulgaria
Efficacy of CHF 6532 on moderate and severe asthma exacerbations rate
Rate of moderate and severe asthma exacerbations during the treatment period with CH 6532 (3 doses tested) or Placebo
Time frame: Over 52 weeks of treatment
Effect of CHF 6532 on severe asthma exacerbations compared to Placebo
Assessment of time to first moderate or severe exacerbation, and of time to first severe exacerbation
Time frame: Over 52 weeks of treatment
Effect of CHF 6532 compared to Placebo in terms of change from baseline in pre-dose morning FEV1 (Forced Expiratory Volume in 1 second)
Assessment of change from Baseline in pre-dose FEV1
Time frame: At Week 52
Effect of CHF 6532 compared to Placebo in terms of change from baseline on St. George's Respiratory Questionnaire (SGRQ)
Assessment of change from Baseline in SGRQ scores (Score range from 0 to 100, with lower scores corresponding to better health)
Time frame: At Week 52
Effect of CHF 6532 compared to Placebo in terms of change from baseline on Asthma Control Questionnaire (ACQ-5)
Assessment of change from Baseline in ACQ-5 scores (Score range from 0=no impairment to 6= maximum impairment)
Time frame: At Week 52
Effect of CHF 6532 compared to Placebo in terms of change from baseline on Asthma Quality of Life Questionnaire (AQLQ+12)
Assessment of change from Baseline in AQLQ+12 scores (Score range from 1=severe impairment to 7= no impairment)
Time frame: At Week 52
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Tablet of CHF 6532 placebo
Pharmacokinetic analysis of CHF 6532
Assessment of the area Under of the plasma concentration-time curve from 0 to the last quantifiable concentration (AUC0-t) of CHF 6532
Time frame: At baseline and 3 months
Pharmacokinetic analysis of CHF 6532
Assessment of the area Under of the plasma concentration versus time curve observed from time 0 up to 8 hours post-dose (AUC0-8h) of CHF 6532
Time frame: At baseline and 3 months
Pharmacokinetic analysis of CHF 6532
Assessment of the value of the maximum plasma concentration (Cmax) of CHF 6532
Time frame: At baseline and 3 months
Pharmacokinetic analysis of CHF 6532
Assessment of the time of the maximum plasma concentration (tmax) of CHF 6532
Time frame: At baseline and 3 months