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.
A cat dander allergen challenge model was used to collect data for all of the Outcome Measures. The cat allergen levels in the model are similar to those found in homes with cats and are capable of inducing lower- and upper-airway responses that have been used to assess the efficacy of several asthma and allergy therapies. Cat allergen exposure was performed in a room furnished with upholstered furniture, a blanket, and a cat litter box. The door was kept closed at all times, except when personnel or study patients were entering or leaving the room. The ventilation system was operating at all times except during cat allergen challenges. Two neutered adult cats were kept in the room at all times and were free to move about except during challenges, at which time they are placed in wire cages. Immediately before a challenge, the blanket was shaken vigorously to distribute cat allergen throughout the room.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
69
Omalizumab was supplied as a sterile, white, preservative-free, lyophilized powder in single-use vials that was reconstituted with sterile water for injection.
Placebo contained the same ingredients as the omalizumab formulation, excluding omalizumab.
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.
Time frame: Week 16
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
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 baseline value. A smaller change in FEV1 indicates a reduced response to the allergen exposure.
Time frame: 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
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 baseline value. A smaller change in FEV1 indicates a reduced response to the allergen exposure.
Time frame: 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
The chest symptom score was defined as the total of 4 sub-scores: Chest tightness, wheezing, shortness of breath, and cough. Each sub-score was rated by the patient on a scale of 0-3 (0=none, 1=mild, 2=moderate, and 3=severe) immediately prior to and approximately every 5 minutes during chamber exposure. The maximum chest symptom score was 12 points. A lower score indicates a reduced response to the allergen exposure and fewer respiratory symptoms.
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Time frame: 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
The NOSS was defined as the total of 4 sub-scores: Nasal congestion, rhinorrhea, nasal pruritus, ocular pruritus, and ocular tearing. Each sub-score was rated by the patient on a scale of 0-3 (0=none, 1=mild, 2=moderate, and 3=severe) immediately prior to and approximately every 5 minutes during chamber exposure. The maximum NOSS was 15 points. A lower score indicates a reduced response to the allergen exposure and fewer nasal-ocular symptoms.
Time frame: Week 16
Duration of Allergen Exposure During the Cat Allergen Exposure Challenge at Week 16
The challenge was stopped if a patient stated that they were extremely uncomfortable and would like to leave the room, the FEV1 has decreased by 50% from the baseline value, or after 60 minutes of exposure. The duration of allergen exposure was the time from when the patient entered the exposure room until the challenge stopped, with a maximum of 60 minutes. A longer duration indicates greater tolerance of the allergen exposure.
Time frame: Week 16