At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 60 enrolled
Drug / intervention
Xolair +1 moredrug
Likely dose
Xolair 450 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Placebo-controlled Study to Demonstrate the Efficacy of Xolair in an Allergen Bronchoprovocation Study in Asthmatic Populations Defined by Serum IgE Concentrations
In Brief
A Phase 4 clinical trial evaluating Xolair and Placebo for Asthma. Completed, enrolled 60 participants across 6 sites in 3 countries.
Detailed Summary
This study was intended to demonstrate that patients with standard and high immunoglobulin E (IgE) levels can be protected from allergen induced broncho-constriction by Xolair
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesGermany, Netherlands, South Africa
CollaboratorsGenentech, Inc., Tanox
Timeline
Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2008
First PostedFeb 2008
Primary CompletionJan 2009
TodayJul 2026
First PostedFeb 27, 2008
Enrollment StartFeb 1, 2008
Primary CompletionJan 1, 2009
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 18.3 years ago
Interventions
Xolairdrug
Xolair (Omalizumab) dose: 2 x 450 mg, 2 x 525 mg or 2 x 600 mg; subcutaneous injection;
Placebodrug
Matching placebo of Xolair (omalizumab), by subcutaneous injection of a solution with a concentration of 125 mg/mL in a supine position.