A Study of Omalizumab in the Prevention of Allergen Induced Airway Obstruction in Adults With Mild Allergic Asthma

Sponsor
Genentech, Inc.
Study ID
NCT00434434
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • omalizumab — DRUG
    Aged Liquid; subcutaneous repeating dose
  • omalizumab — DRUG
    Lyophilized; subcutaneous repeating dose
  • placebo — DRUG
    Subcutaneous repeating dose

Study Details

This was a multicenter, randomized, double-blind, parallel-group, three-arm, placebo-controlled study designed to demonstrate the efficacy of two different formulations of omalizumab compared with placebo in reducing the airway reaction to an inhaled aeroallergen solution in adult subjects with mild allergic asthma.

Key Dates

Start date
Oct 31, 2007
Status verified
Dec 2022
Primary completion
Feb 28, 2009
Completion
Jun 30, 2009

Study Design

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

Arms

  • Experimental: 1
  • Experimental: 2
  • Placebo Comparator: 3

Primary Outcome Measure

Change in Logarithmically Transformed (log2) Allergen PC15 Concentration (Allergen Concentration Required to Evoke a 15% Decrease in FEV1) [ Time Frame: From baseline to Week 16 ]

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