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

NCT00495612 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2017-06-08

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Omalizumab

Omalizumab was supplied as a sterile, white, preservative-free, lyophilized powder in single-use vials that was reconstituted with sterile water for injection.

DRUG

Placebo

Placebo contained the same ingredients as the omalizumab formulation, excluding omalizumab.

Sponsors & Collaborators

  • Genentech, Inc.

    lead INDUSTRY

Principal Investigators

  • Paul Solari, MD · Genentech, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2009-06-30
Completion
2009-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00495612 on ClinicalTrials.gov