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 (Clinical Trial)
Estimated Enrollment: 1640 participants
Intervention Model: Parallel Assignment
Intervention Model Description: Placebo controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: double-blind
Primary Purpose: Treatment
Official Title: A 52 Week, Randomised, Double Blind, Multinational, Multicentre, 4-arm Parallel Group Trial to Assess the Efficacy and Safety of 3 Doses of CHF 6532 Compared to Placebo on Top of Standard of Care in Patients With Uncontrolled Severe Eosinophilic Asthma
Actual Study Start Date: August 28, 2019
Estimated Primary Completion Date: January 2023
Estimated Study Completion Date: January 2023
- Experimental: Treatment A
- Experimental: Treatment B
- Experimental: Treatment C
- Placebo Comparator: Treatment D
|Date last updated at source||2019-09-27|
|Study start date||2019-08-28|
|Estimated primary completion date||2023-01-01|