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

NCT00495612 | Completed Phase 4 Results

• 1 other identifier: Q4229n
• Study Type: interventional
• Target: 69
• Locations: 0 countries
• Sites: N/A

Brief 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

Asthma

Keywords

Xolair; Allergic asthma; Cat allergy

Outcome Measures

Primary Outcomes (1)

• 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

  Spirometry was performed prior to chamber exposure, approximately every 10 minutes during exposure, and approximately every 20 minutes after exposure until FEV1 returned to within 10% of the baseline value. A smaller change in FEV1 indicates a reduced response to the allergen exposure.

  Week 16

Secondary Outcomes (5)

• Percent Change in Forced Expiratory Volume in 1 Second (FEV1) at 20 Minutes of a 1-hour Cat Allergen Exposure From Pre-challenge at Week 16

  Week 16

• Maximum Percent Change in Forced Expiratory Volume in 1 Second (FEV1) During a 1-hour Cat Allergen Exposure From Pre-challenge at Week 16

  Week 16

• Area Under the Curve (AUC) of Change in Chest Symptom Score During a 1-hour Cat Allergen Exposure From Pre-challenge at Week 16

  Week 16

• Area Under the Curve (AUC) of Change in Nasal-ocular Symptom Score (NOSS) During a 1-hour Cat Allergen Exposure From Pre-challenge at Week 16

  Week 16

• Duration of Allergen Exposure During the Cat Allergen Exposure Challenge at Week 16

  Week 16

Study Arms (2)

Omalizumab

EXPERIMENTAL

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.

Drug: Omalizumab

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

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.

Also known as: Xolair

Omalizumab

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent form.
• to 65 years of age and in general good health.
• History of moderate asthma, defined by the need for routine inhaled corticosteroids for at least the last 90 days prior to screening as well as the routine use of additional medication(s) (eg, short- or long-acting β2-agonists, leukotriene antagonist, or theophylline) to control asthma symptoms.
• History of cat dander-induced asthma in the 3 years prior to randomization.
• Cat exposure at the time of screening must remain constant throughout the duration of the study (eg, patients having cat exposure at home must continue to have regular exposure during the study; patients having no cat exposure at home must continue having no exposure at home during the study).
• Positive skin test to cat allergen, defined as a ≥ 5 mm wheal over the saline control wheal.
• Baseline forced expiratory volume in 1 second (FEV1) ≥ 70% predicted after withholding long-acting β2-agonists for \> 36 hours and short-acting β2-agonists for \> 6 hours.
• Eligibility per the study drug dosing table (serum IgE level ≥ 30 to ≤ 700 IU/mL and body weight ≥ 30 to ≤ 150 kg) and ability to be dosed per the dosing table.
• Less than 10 pack-years of smoking history.
• Demonstrated ≥ 20% fall in FEV1 during up to 1 hour of exposure in the cat environmental exposure chamber and ability to withstand exposure for at least 20 minutes.

You may not qualify if:

• Unstable asthma (defined as a hospitalization within the prior 6 months or an exacerbation requiring oral corticosteroids within 4 weeks of study entry).
• Life-threatening episode of asthma in the previous year.
• History of severe allergic reactions to cat exposure.
• Having undergone cat immunotherapy within 6 months prior to screening.
• Upper respiratory infection within 2 weeks of study entry.
• Active lung disease other than asthma.
• Significant medical illness other than asthma, including malignancies, parasitic infections, immune system disorders, and thrombocytopenia.
• History of hypersensitivity to the study drug or to drugs with similar chemical structures or to any ingredients, including excipients of the study medication or drugs related to omalizumab (eg, monoclonal antibodies, polyclonal gamma globulin).
• Documented medical history of anaphylaxis.
• Receipt of other investigational drugs within 30 days or 5 half-lives prior to screening, whichever is longer.
• Pregnant women and nursing mothers.
• Treatment with omalizumab within 12 months prior to screening.
• History of drug or alcohol abuse that, in the judgment of the investigator, may put the patient at risk for being unable to participate fully in the study.

Sponsors & Collaborators

• Genentech, Inc.: lead

MeSH Terms

Conditions

Asthma

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Results Point of Contact

• Title: Medical Communications
• Organization: Genentech, Inc.

800 821-8590

Study Officials

• Paul Solari, MD

  Genentech, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2007
• First Posted: July 3, 2007
• Study Start: September 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: June 8, 2017
• Results First Posted: March 27, 2013

Record last verified: 2017-05