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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
Novartis Investigator Site
Berlin, Germany
Novartis Investigator Site
Frankfurt, Germany
Novartis Investigator Site
Munich, Germany
Novartis Investigator Site
Groningen, Netherlands
Early Phase Allergic Response After Treatment With Study Drug in Active and Placebo Patients
The EAR was defined as the maximum percent drop in forced expiratory volume in one second (FEV1) in the first 30 minutes after the challenge: EAR = 100\* \[ FEV1 (0) - Minimum FEV1 (10, 15, 30 min)\] / FEV1 (0). For FEV1 (0), the "best post saline (Control) FEV1" was used. The EAR was analyzed using a linear (ANCOVA) model with a fixed effect for treatment groups and the EAR from the baseline challenge was used as a covariate.
Time frame: Week 8, Week 16
Late Phase Allergic Response After Treatment With Study Drug in Active and Placebo Patients
Late-phase allergic response (LAR) was only determined for those patients who had an LAR \>= 15% at baseline allergen bronchoprovocation testing. For Forced Expiratory Volume, FEV1 (0), the "best post saline (Control) FEV1" was used. LAR (%) = 100\*\[FEV1 (0) - Minimum FEV1 (3-8h)\]/FEV1 (0).
Time frame: Week 0, Week 8 and Week 16
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Novartis Investigator Site
Bloemfontein, South Africa
Novartis Investigator Site
Durban, South Africa