EUCTR2012-002298-69-PTActive, not recruitingNot Applicable
A Multi-Center, Randomized, Double Blind, Placebo and Active-Controlled study with exploratory dose-ranging, to investigate the efficacy and safety of 16 weeks treatment with subcutaneous QGE031 in asthma patients not adequately controlled with high-dose inhaled corticosteroids and long acting ß2-agonists
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- ovartis Pharma Services AG
- Enrollment
- 457
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •-A diagnosis of allergic asthma, uncontrolled on current medication
- •-History of at least 1 asthma exacerbation(s) 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 must also be demonstrated (historical positive reversibility or bronchoprovocation result can be used)
- •Other inclusion criteria are listed in the clinical study protocol
- •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 366
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 91
Exclusion Criteria
- •-Baseline IgE levels or body weight outside the omalizumab dosing table
- •-Use of tobacco products within the previous 6 months
- •-Recent asthma attack/exacerbation or asthma worsening/respiratory infection
- •Other exclusion criteria are listed in the clinical study protocol.
Investigators
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