Trial Outcomes & Findings for A Study of Omalizumab in Preventing Bronchoconstriction Following Environmental Cat Dander Exposure in Patients With Cat Dander-induced Asthma (NCT NCT00495612)
NCT ID: NCT00495612
Last Updated: 2017-06-08
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
69 participants
Primary outcome timeframe
Week 16
Results posted on
2017-06-08
Participant Flow
Participant milestones
| Measure |
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
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.
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
33
|
|
Overall Study
COMPLETED
|
32
|
33
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
| Measure |
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
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Subject's Decision to Withdraw
|
3
|
0
|
Baseline Characteristics
A Study of Omalizumab in Preventing Bronchoconstriction Following Environmental Cat Dander Exposure in Patients With Cat Dander-induced Asthma
Baseline characteristics by cohort
| Measure |
Omalizumab
n=36 Participants
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
n=33 Participants
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.
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.6 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
38.5 years
STANDARD_DEVIATION 12.3 • n=7 Participants
|
36.5 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 16Population: Modified intent-to-treat population: All randomized patients that received at least 1 dose of study drug and who had at least 1 primary efficacy data point, ie, at least 1 FEV1 measurement during the 1-hour cat allergen exposure 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.
Outcome measures
| Measure |
Omalizumab
n=32 Participants
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
n=33 Participants
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.
|
|---|---|---|
|
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
|
15.03 Percent change from pre-challenge*hours
Standard Deviation 15.90
|
27.80 Percent change from pre-challenge*hours
Standard Deviation 15.28
|
SECONDARY outcome
Timeframe: Week 16Population: Modified intent-to-treat population: All randomized patients that received at least 1 dose of study drug and who had at least 1 primary efficacy data point, ie, at least 1 FEV1 measurement during the 1-hour cat allergen exposure 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.
Outcome measures
| Measure |
Omalizumab
n=32 Participants
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
n=33 Participants
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.
|
|---|---|---|
|
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
|
15.28 Percent change
Standard Deviation 18.00
|
29.97 Percent change
Standard Deviation 17.77
|
SECONDARY outcome
Timeframe: Week 16Population: Modified intent-to-treat population: All randomized patients that received at least 1 dose of study drug and who had at least 1 primary efficacy data point, ie, at least 1 FEV1 measurement during the 1-hour cat allergen exposure 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.
Outcome measures
| Measure |
Omalizumab
n=32 Participants
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
n=33 Participants
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.
|
|---|---|---|
|
Maximum Percent Change in Forced Expiratory Volume in 1 Second (FEV1) During a 1-hour Cat Allergen Exposure From Pre-challenge at Week 16
|
21.07 Percent change
Standard Deviation 17.68
|
33.52 Percent change
Standard Deviation 16.03
|
SECONDARY outcome
Timeframe: Week 16Population: Modified intent-to-treat population: All randomized patients that received at least 1 dose of study drug and who had at least 1 primary efficacy data point, ie, at least 1 FEV1 measurement during the 1-hour cat allergen exposure 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.
Outcome measures
| Measure |
Omalizumab
n=32 Participants
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
n=33 Participants
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.
|
|---|---|---|
|
Area Under the Curve (AUC) of Change in Chest Symptom Score During a 1-hour Cat Allergen Exposure From Pre-challenge at Week 16
|
2.205 Units on a scale*hours
Standard Deviation 2.066
|
5.602 Units on a scale*hours
Standard Deviation 2.873
|
SECONDARY outcome
Timeframe: Week 16Population: Modified intent-to-treat population: All randomized patients that received at least 1 dose of study drug and who had at least 1 primary efficacy data point, ie, at least 1 FEV1 measurement during the 1-hour cat allergen exposure 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.
Outcome measures
| Measure |
Omalizumab
n=32 Participants
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
n=33 Participants
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.
|
|---|---|---|
|
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
|
2.448 Units on a scale*hours
Standard Deviation 1.720
|
5.192 Units on a scale*hours
Standard Deviation 3.141
|
SECONDARY outcome
Timeframe: Week 16Population: Modified intent-to-treat population: All randomized patients that received at least 1 dose of study drug and who had at least 1 primary efficacy data point, ie, at least 1 FEV1 measurement during the 1-hour cat allergen exposure 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.
Outcome measures
| Measure |
Omalizumab
n=32 Participants
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
n=33 Participants
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.
|
|---|---|---|
|
Duration of Allergen Exposure During the Cat Allergen Exposure Challenge at Week 16
|
50 Minutes
Interval 37.0 to
The upper limit of the confidence interval could not be estimated due to too few events, defined as exiting the challenge before 60 minutes.
|
22 Minutes
Interval 10.0 to 30.0
|
Adverse Events
Omalizumab
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Omalizumab
n=36 participants at risk
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
n=33 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/36 • Adverse events were collected from the time informed consent was given until a patient completed the study or discontinued prematurely.
Safety analyses were based on the treated subjects. Treated subjects were defined as randomized subjects who received at least 1 dose of study drug. The treatment groups were based on the treatment subjects actually received regardless of their assigned treatment.
|
6.1%
2/33 • Adverse events were collected from the time informed consent was given until a patient completed the study or discontinued prematurely.
Safety analyses were based on the treated subjects. Treated subjects were defined as randomized subjects who received at least 1 dose of study drug. The treatment groups were based on the treatment subjects actually received regardless of their assigned treatment.
|
|
General disorders
Chest discomfort
|
5.6%
2/36 • Adverse events were collected from the time informed consent was given until a patient completed the study or discontinued prematurely.
Safety analyses were based on the treated subjects. Treated subjects were defined as randomized subjects who received at least 1 dose of study drug. The treatment groups were based on the treatment subjects actually received regardless of their assigned treatment.
|
3.0%
1/33 • Adverse events were collected from the time informed consent was given until a patient completed the study or discontinued prematurely.
Safety analyses were based on the treated subjects. Treated subjects were defined as randomized subjects who received at least 1 dose of study drug. The treatment groups were based on the treatment subjects actually received regardless of their assigned treatment.
|
|
Immune system disorders
Hypersensitivity
|
13.9%
5/36 • Adverse events were collected from the time informed consent was given until a patient completed the study or discontinued prematurely.
Safety analyses were based on the treated subjects. Treated subjects were defined as randomized subjects who received at least 1 dose of study drug. The treatment groups were based on the treatment subjects actually received regardless of their assigned treatment.
|
21.2%
7/33 • Adverse events were collected from the time informed consent was given until a patient completed the study or discontinued prematurely.
Safety analyses were based on the treated subjects. Treated subjects were defined as randomized subjects who received at least 1 dose of study drug. The treatment groups were based on the treatment subjects actually received regardless of their assigned treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
13.9%
5/36 • Adverse events were collected from the time informed consent was given until a patient completed the study or discontinued prematurely.
Safety analyses were based on the treated subjects. Treated subjects were defined as randomized subjects who received at least 1 dose of study drug. The treatment groups were based on the treatment subjects actually received regardless of their assigned treatment.
|
15.2%
5/33 • Adverse events were collected from the time informed consent was given until a patient completed the study or discontinued prematurely.
Safety analyses were based on the treated subjects. Treated subjects were defined as randomized subjects who received at least 1 dose of study drug. The treatment groups were based on the treatment subjects actually received regardless of their assigned treatment.
|
|
Infections and infestations
Urinary tract infection
|
5.6%
2/36 • Adverse events were collected from the time informed consent was given until a patient completed the study or discontinued prematurely.
Safety analyses were based on the treated subjects. Treated subjects were defined as randomized subjects who received at least 1 dose of study drug. The treatment groups were based on the treatment subjects actually received regardless of their assigned treatment.
|
0.00%
0/33 • Adverse events were collected from the time informed consent was given until a patient completed the study or discontinued prematurely.
Safety analyses were based on the treated subjects. Treated subjects were defined as randomized subjects who received at least 1 dose of study drug. The treatment groups were based on the treatment subjects actually received regardless of their assigned treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/36 • Adverse events were collected from the time informed consent was given until a patient completed the study or discontinued prematurely.
Safety analyses were based on the treated subjects. Treated subjects were defined as randomized subjects who received at least 1 dose of study drug. The treatment groups were based on the treatment subjects actually received regardless of their assigned treatment.
|
6.1%
2/33 • Adverse events were collected from the time informed consent was given until a patient completed the study or discontinued prematurely.
Safety analyses were based on the treated subjects. Treated subjects were defined as randomized subjects who received at least 1 dose of study drug. The treatment groups were based on the treatment subjects actually received regardless of their assigned treatment.
|
|
Nervous system disorders
Headache
|
19.4%
7/36 • Adverse events were collected from the time informed consent was given until a patient completed the study or discontinued prematurely.
Safety analyses were based on the treated subjects. Treated subjects were defined as randomized subjects who received at least 1 dose of study drug. The treatment groups were based on the treatment subjects actually received regardless of their assigned treatment.
|
12.1%
4/33 • Adverse events were collected from the time informed consent was given until a patient completed the study or discontinued prematurely.
Safety analyses were based on the treated subjects. Treated subjects were defined as randomized subjects who received at least 1 dose of study drug. The treatment groups were based on the treatment subjects actually received regardless of their assigned treatment.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/36 • Adverse events were collected from the time informed consent was given until a patient completed the study or discontinued prematurely.
Safety analyses were based on the treated subjects. Treated subjects were defined as randomized subjects who received at least 1 dose of study drug. The treatment groups were based on the treatment subjects actually received regardless of their assigned treatment.
|
6.1%
2/33 • Adverse events were collected from the time informed consent was given until a patient completed the study or discontinued prematurely.
Safety analyses were based on the treated subjects. Treated subjects were defined as randomized subjects who received at least 1 dose of study drug. The treatment groups were based on the treatment subjects actually received regardless of their assigned treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
19.4%
7/36 • Adverse events were collected from the time informed consent was given until a patient completed the study or discontinued prematurely.
Safety analyses were based on the treated subjects. Treated subjects were defined as randomized subjects who received at least 1 dose of study drug. The treatment groups were based on the treatment subjects actually received regardless of their assigned treatment.
|
33.3%
11/33 • Adverse events were collected from the time informed consent was given until a patient completed the study or discontinued prematurely.
Safety analyses were based on the treated subjects. Treated subjects were defined as randomized subjects who received at least 1 dose of study drug. The treatment groups were based on the treatment subjects actually received regardless of their assigned treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.6%
2/36 • Adverse events were collected from the time informed consent was given until a patient completed the study or discontinued prematurely.
Safety analyses were based on the treated subjects. Treated subjects were defined as randomized subjects who received at least 1 dose of study drug. The treatment groups were based on the treatment subjects actually received regardless of their assigned treatment.
|
36.4%
12/33 • Adverse events were collected from the time informed consent was given until a patient completed the study or discontinued prematurely.
Safety analyses were based on the treated subjects. Treated subjects were defined as randomized subjects who received at least 1 dose of study drug. The treatment groups were based on the treatment subjects actually received regardless of their assigned treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.8%
1/36 • Adverse events were collected from the time informed consent was given until a patient completed the study or discontinued prematurely.
Safety analyses were based on the treated subjects. Treated subjects were defined as randomized subjects who received at least 1 dose of study drug. The treatment groups were based on the treatment subjects actually received regardless of their assigned treatment.
|
6.1%
2/33 • Adverse events were collected from the time informed consent was given until a patient completed the study or discontinued prematurely.
Safety analyses were based on the treated subjects. Treated subjects were defined as randomized subjects who received at least 1 dose of study drug. The treatment groups were based on the treatment subjects actually received regardless of their assigned treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.6%
2/36 • Adverse events were collected from the time informed consent was given until a patient completed the study or discontinued prematurely.
Safety analyses were based on the treated subjects. Treated subjects were defined as randomized subjects who received at least 1 dose of study drug. The treatment groups were based on the treatment subjects actually received regardless of their assigned treatment.
|
0.00%
0/33 • Adverse events were collected from the time informed consent was given until a patient completed the study or discontinued prematurely.
Safety analyses were based on the treated subjects. Treated subjects were defined as randomized subjects who received at least 1 dose of study drug. The treatment groups were based on the treatment subjects actually received regardless of their assigned treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
5.6%
2/36 • Adverse events were collected from the time informed consent was given until a patient completed the study or discontinued prematurely.
Safety analyses were based on the treated subjects. Treated subjects were defined as randomized subjects who received at least 1 dose of study drug. The treatment groups were based on the treatment subjects actually received regardless of their assigned treatment.
|
0.00%
0/33 • Adverse events were collected from the time informed consent was given until a patient completed the study or discontinued prematurely.
Safety analyses were based on the treated subjects. Treated subjects were defined as randomized subjects who received at least 1 dose of study drug. The treatment groups were based on the treatment subjects actually received regardless of their assigned treatment.
|
Additional Information
Medical Communications
Genentech, Inc.
Phone: 800 821-8590
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER