NCT04049175

Efficacy and Safety of CHF 6532 in Patients With Uncontrolled Severe Eosinophilic Asthma

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 810 (actual)
• Sponsor: Chiesi Farmaceutici S.p.A. · Industry
• Sex: All
• Age: 12 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Asthma; Eosinophilic

Interventions

Type	Name	Description
DRUG	Treatment A	Tablet of CHF 6532
DRUG	Treatment B	Tablet of CHF 6532
DRUG	Treatment C	Tablet of CHF 6532
DRUG	Treatment D	Tablet of CHF 6532 placebo

Timeline

• Start date: 2019-08-28
• Primary completion: 2020-10-19
• Completion: 2021-02-01
• First posted: 2019-08-08
• Last updated: 2022-04-08

Locations

1 site across 1 country: Bulgaria