Clinical Trials Logo
  1. Home
  2. Asthma; Eosinophilic
  3. NCT04049175

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

Asthma; Eosinophilic Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04049175
Study type Interventional
Source Chiesi Farmaceutici S.p.A.
Contact
Status Terminated
Phase Phase 3
Start date August 28, 2019
Completion date February 1, 2021
View Details
See also
  Status Clinical Trial Phase
Completed NCT04742504 - Interaction Between Benralizumab and Basophils in Eosinophilic Asthma
Recruiting NCT04565483 - Predictive Signature of Benralizumab Response Phase 4
Completed NCT04181190 - Effects of Anti-IL5 Biological Treatments on Blood IgE Levels in Severe Asthmatic Patients
Recruiting NCT05787678 - Dupilumab Efficacy on Bronchial Inflammation, Small Airways Disfunction and Mucous Secretion
Completed NCT04456270 - Asthma Control in a Dutch Primary Care Population
Not yet recruiting NCT05091385 - Efficacy of Mepolizumab in Polish Patients With Severe Eosinophilic Asthma
Recruiting NCT05078281 - Patients With Severe Eosinophilic Asthma Treated With Benralizumab
Recruiting NCT04512521 - Functional Lung MRI for Early Treatment Response Assessment for Patients With Eosinophilic Asthma
Recruiting NCT05813288 - A Study to Assess the Effect of Dexpramipexole in Adolescents and Adults With Severe Eosinophilic Asthma (EXHALE-3) Phase 3
Recruiting NCT04319705 - Anti-viral Effects of Azithromycin in Patients With Asthma and COPD Phase 4
Recruiting NCT06288516 - BenRalizumab Effect on Airway Remodeling in Severe asTHma Phase 4
Active, not recruiting NCT03733535 - Evaluating the Effect of Benralizumab in Severe, Poorly-controlled Eosinophilic Asthma Using Inhaled Hyperpolarized 129-Xenon MRI N/A
Not yet recruiting NCT05241769 - The Influence of Inhaled CorticoSteroids Adherence on Treatment Response to Mepolizumab in Severe Eosinophilic Asthma
Not yet recruiting NCT05404763 - Mepolizumab and Physical Activity in Severe Asthma
Not yet recruiting NCT04924478 - Evaluation of Volatile Organic Compounds in Mepolizumab Therapy
Recruiting NCT05763121 - A Study to Assess the Effect of Dexpramipexole in Adolescents and Adults With Severe Eosinophilic Asthma. Phase 3
Recruiting NCT05748600 - A Study to Assess the Effect of Dexpramipexole in Adolescents and Adults With Eosinophilic Asthma Phase 3
Completed NCT03453021 - Effect of Mepolizumab on Decrease of Systemic Corticosteroids in Patients With Severe Eosinophilic Asthma
Active, not recruiting NCT04612556 - Efficacy of Mepolizumab in Severe Asthmatics on a Long Term (MESILICO)
Completed NCT04710134 - Efficacy of Reslizumab Dose Escalation in Patients With Severe Asthma Phase 4