Trial Outcomes & Findings for A Study of Omalizumab in the Prevention of Allergen Induced Airway Obstruction in Adults With Mild Allergic Asthma (NCT NCT00434434)
NCT ID: NCT00434434
Last Updated: 2022-12-14
Results Overview
The primary analysis included two tests: a test for superiority of the lyophilized formulation of omalizumab compared with placebo in the change of allergen concentration and a test for the superiority of the aged liquid omalizumab compared with placebo. The difference for the change in the allergen concentration between the lyophilized formulation of omalizumab and placebo, and between the aged liquid omalizumab and placebo were assessed by the exact Wilcoxon-Mann-Whitney test.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
61 participants
Primary outcome timeframe
From baseline to Week 16
Results posted on
2022-12-14
Participant Flow
Participant milestones
| Measure |
Liquid Omalizumab
Liquid omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
|
Lyopholized Omalizumab
Lyophilized omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
|
Placebo
Lyophilized placebo subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
|
|---|---|---|---|
|
Overall Study
STARTED
|
23
|
24
|
14
|
|
Overall Study
COMPLETED
|
21
|
24
|
13
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Omalizumab in the Prevention of Allergen Induced Airway Obstruction in Adults With Mild Allergic Asthma
Baseline characteristics by cohort
| Measure |
Liquid Omalizumab
n=23 Participants
Liquid omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
|
Lyopholized Omalizumab
n=24 Participants
Lyophilized omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
|
Placebo
n=14 Participants
Lyophilized placebo subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
18 to 40 years
|
18 participants
n=5 Participants
|
21 participants
n=7 Participants
|
11 participants
n=5 Participants
|
50 participants
n=4 Participants
|
|
Age, Customized
41 to 65 years
|
5 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
9 participants
n=4 Participants
|
|
Age, Customized
> 65 years
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Age, Continuous
|
28.5 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
30.6 years
STANDARD_DEVIATION 12.8 • n=7 Participants
|
32.0 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
30.1 years
STANDARD_DEVIATION 11.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From baseline to Week 16Population: Modified intent-to-treat (ITT) population
The primary analysis included two tests: a test for superiority of the lyophilized formulation of omalizumab compared with placebo in the change of allergen concentration and a test for the superiority of the aged liquid omalizumab compared with placebo. The difference for the change in the allergen concentration between the lyophilized formulation of omalizumab and placebo, and between the aged liquid omalizumab and placebo were assessed by the exact Wilcoxon-Mann-Whitney test.
Outcome measures
| Measure |
Liquid Omalizumab
n=22 Participants
Liquid omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
|
Lyopholized Omalizumab
n=23 Participants
Lyophilized omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
|
Placebo
n=13 Participants
Lyophilized placebo subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
|
|---|---|---|---|
|
Change in Logarithmically Transformed (log2) Allergen PC15 Concentration (Allergen Concentration Required to Evoke a 15% Decrease in FEV1)
|
1.15 concentration change
Interval -2.3 to 4.03
|
1.85 concentration change
Interval -1.1 to 3.5
|
0.36 concentration change
Interval -1.09 to 3.09
|
SECONDARY outcome
Timeframe: From baseline to Week 16Population: Modified ITT population
FEV1 is the volume exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity, measured in liters. The allergen FEV1 two-point slope is defined as the final percent change in FEV1 from pre-challenge value divided by the final value of allergen concentration used in the challenge.
Outcome measures
| Measure |
Liquid Omalizumab
n=22 Participants
Liquid omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
|
Lyopholized Omalizumab
n=23 Participants
Lyophilized omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
|
Placebo
n=13 Participants
Lyophilized placebo subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
|
|---|---|---|---|
|
Ratio of the Allergen Forced Expiratory Volume at One Second (FEV1) Two-point Slope at the Week 16 Allergen Challenge to the Allergen FEV1 Two-point Slope at the Baseline Allergen Challenge
|
0.52 ratio of FEV1
Interval -0.09 to 3.18
|
0.29 ratio of FEV1
Interval -0.26 to 2.08
|
0.95 ratio of FEV1
Interval 0.12 to 2.2
|
Adverse Events
Liquid Omalizumab
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Lyopholized Omalizumab
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Liquid Omalizumab
n=23 participants at risk
Liquid omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
|
Lyopholized Omalizumab
n=24 participants at risk
Lyophilized omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
|
Placebo
n=14 participants at risk
Lyophilized placebo subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
|
|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Abortion Spontaneous
|
0.00%
0/23
Safety evaluable population
|
4.2%
1/24
Safety evaluable population
|
0.00%
0/14
Safety evaluable population
|
|
General disorders
Pyrexia
|
0.00%
0/23
Safety evaluable population
|
4.2%
1/24
Safety evaluable population
|
0.00%
0/14
Safety evaluable population
|
Other adverse events
| Measure |
Liquid Omalizumab
n=23 participants at risk
Liquid omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
|
Lyopholized Omalizumab
n=24 participants at risk
Lyophilized omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
|
Placebo
n=14 participants at risk
Lyophilized placebo subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
|
|---|---|---|---|
|
General disorders
Chest Discomfort
|
0.00%
0/23
Safety evaluable population
|
4.2%
1/24
Safety evaluable population
|
7.1%
1/14
Safety evaluable population
|
|
General disorders
Facial Pain
|
0.00%
0/23
Safety evaluable population
|
0.00%
0/24
Safety evaluable population
|
7.1%
1/14
Safety evaluable population
|
|
Infections and infestations
Nasopharyngitis
|
13.0%
3/23
Safety evaluable population
|
8.3%
2/24
Safety evaluable population
|
7.1%
1/14
Safety evaluable population
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
8.7%
2/23
Safety evaluable population
|
0.00%
0/24
Safety evaluable population
|
14.3%
2/14
Safety evaluable population
|
|
Injury, poisoning and procedural complications
Joint Dislocation
|
4.3%
1/23
Safety evaluable population
|
0.00%
0/24
Safety evaluable population
|
7.1%
1/14
Safety evaluable population
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/23
Safety evaluable population
|
0.00%
0/24
Safety evaluable population
|
7.1%
1/14
Safety evaluable population
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/23
Safety evaluable population
|
0.00%
0/24
Safety evaluable population
|
7.1%
1/14
Safety evaluable population
|
|
Injury, poisoning and procedural complications
Joint Injury
|
0.00%
0/23
Safety evaluable population
|
0.00%
0/24
Safety evaluable population
|
7.1%
1/14
Safety evaluable population
|
|
Nervous system disorders
Headache
|
8.7%
2/23
Safety evaluable population
|
8.3%
2/24
Safety evaluable population
|
0.00%
0/14
Safety evaluable population
|
|
Nervous system disorders
Sinus Headache
|
0.00%
0/23
Safety evaluable population
|
0.00%
0/24
Safety evaluable population
|
7.1%
1/14
Safety evaluable population
|
|
Psychiatric disorders
Middle Insomnia
|
0.00%
0/23
Safety evaluable population
|
0.00%
0/24
Safety evaluable population
|
7.1%
1/14
Safety evaluable population
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
4.3%
1/23
Safety evaluable population
|
4.2%
1/24
Safety evaluable population
|
7.1%
1/14
Safety evaluable population
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
4.3%
1/23
Safety evaluable population
|
4.2%
1/24
Safety evaluable population
|
7.1%
1/14
Safety evaluable population
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/23
Safety evaluable population
|
0.00%
0/24
Safety evaluable population
|
7.1%
1/14
Safety evaluable population
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/23
Safety evaluable population
|
0.00%
0/24
Safety evaluable population
|
7.1%
1/14
Safety evaluable population
|
|
Skin and subcutaneous tissue disorders
Periorbital Oedema
|
0.00%
0/23
Safety evaluable population
|
0.00%
0/24
Safety evaluable population
|
7.1%
1/14
Safety evaluable population
|
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