Evaluation of bronchial remodeling during mepolizumab treatment in severe eosinophilic asthma

Phase 1

• Conditions: severe oesinophilic asthma; MedDRA version: 20.0 Level: LLT Classification code 10068462 Term: Eosinophilic asthma System Organ Class: 100000004855; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2018-002591-40-FR
• Lead Sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-27
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

- Age = 18 years
- Severe asthmatics for which the indication of a treatment by mepolizumab is posed by the clinician, according to the criteria of prescription defined in France:
• a blood eosinophil level = 300 / µL in the last 12 months;
• and at least one of the following two criteria:
- at least two episodes of asthmatic exacerbations requiring treatment with oral corticosteroid (=3 days each) in the last 12 months despite a combination of high dose inhaled corticosteroids and a long-acting bronchodilator (LABA) ( stage 4/5 GINA);
- or treatment with oral corticosteroids for at least six months in the last twelve months.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

- Refusal to sign a written consent to participation.
- Contraindication to bronchial endoscopy (asthma exacerbation, contraindication to the use of Xylocaine 5% for oral solution) or contraindication to performing bronchial biopsies (taking anticoagulant or the combination of two antiplatelet treatments
- Contraindication to mepolizumab according to the Summary of Product Characteristics
- Pregnant or lactating woman
- Not affiliated to a social security scheme

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified