Efficacy and safety of QGE031 versus placebo in patients aged 18-75 years with asthma not adequately controlled with standard of care medication (inhaled corticosteroids plus long lasting beta agonists with or without oral corticosteroids)

Phase 1

• Conditions: Severe Asthma; MedDRA version: 18.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2014-003155-57-BE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-21
• Last Update Posted: 30 April 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 440

Inclusion Criteria

A diagnosis of allergic asthma, uncontrolled on current medication.
•History of at least 2 asthma exacerbations during the last 1 year
•Forced Expiratory Volume in one second (FEV1) of = 40% and = 80%
of the predicted normal value; reversibility following administration of
bronchodilator.
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 293
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 147

Exclusion Criteria

•Use of tobacco products within the previous 6 months (Social occasional smokers may be included).
•Recent asthma attack/exacerbation or asthma worsening/ respiratory
infection.

Study & Design

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