A Study of Omalizumab in Preventing Bronchoconstriction Following Environmental Cat Dander Exposure in Patients With Cat Dander-induced Asthma

Sponsor
Genentech, Inc.
Study ID
NCT00495612
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Omalizumab — DRUG
    Omalizumab was supplied as a sterile, white, preservative-free, lyophilized powder in single-use vials that was reconstituted with sterile water for injection.
  • Placebo — DRUG
    Placebo contained the same ingredients as the omalizumab formulation, excluding omalizumab.

Study Details

This was a 3-center, randomized, double-blind, parallel-group, placebo-controlled study with a 16-week treatment phase to determine whether subcutaneous omalizumab, compared with placebo, reduces the degree of bronchoconstriction induced by environmental cat dander exposure in patients 18-65 years old with stable, moderate asthma and a history of cat dander-induced asthma symptoms.

Key Dates

Start date
Sep 30, 2007
Status verified
May 2017
Primary completion
Jun 30, 2009
Completion
Jun 30, 2009

Study Design

Enrollment
69 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Omalizumab
    Patients received omalizumab via subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. The dose administered and the dosing interval were determined by serum total IgE level and body weight (measured before the start of treatment) per the study drug dosing table.
  • Placebo Comparator: Placebo
    Patients received placebo as a subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. Patients received injections at the same time intervals as the omalizumab group.

Primary Outcome Measure

Area Under the Curve (AUC) of Percent Change in Forced Expiratory Volume in 1 Second (FEV1) Over a 1-hour Cat Allergen Exposure From Pre-challenge at Week 16 [ Time Frame: Week 16 ]

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