Treating severe paediatric asthma; a randomised controlled trial of mepolizumab and omalizumab

Phase 1

• Conditions: Asthma; MedDRA version: 20.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2019-004085-17-GB
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-26
• Last Update Posted: 10 August 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Confirmed diagnosis of asthma
On high dose maintenance treatment (>/=800mcg per day budesonide/equivalent and long-acting beta agonist)
At least 4 severe attacks (defined as the need for a short course of oral steroids, or hospitalisation) in the previous 12 months, OR if on maintenance oral steroids then at least 2 severe attacks in the last 12 months.
+/-
Poor asthma control defined as a score of <20 on the Asthma Control Test (ACT) [children aged 12-16 years], or childhood Asthma Control Test (cACT) [children aged 6-11 years].
Are the trial subjects under 18? yes
Number of subjects for this age range: 150
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1.As a result of medical interview, physical examination or screening investigation the physician responsible considers the child unfit for the study or has a risk of non-compliance with study procedures.
2.The child has a history of drug or other allergy, which, in the opinion of the responsible physician, contra-indicates their participation.
3.Participant is female who is pregnant, lactating or within 6 weeks post-partum or breast feeding.
4.The child has participated within 3 months in a study using a new molecular entity, another study investigating drugs or in a study with invasive procedures.
5.Significant alternative diagnoses that may mimic or complicate asthma, in particular dysfunctional breathing, panic attacks, and overt psychosocial problems (if these are thought to be the major problem rather than in addition to severe asthma)
6.Significant other primary pulmonary disorders in particular cystic fibrosis, or interstitial lung disease
7.Diagnosis of chronic inflammatory diseases other than asthma (e.g. inflammatory bowel disease)

Study & Design

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