Persistent Allergic Asthma
Conditions
Keywords
Asthma; asthma management; asthma impairment ; Xolair ; omalizumab
Brief summary
This study will evaluate the effect of omalizumab on markers of impairment in patients with inadequately controlled persistent allergic asthma on Step 4 or above therapy as defined in the 2007 National Heart, Lung, and Blood Institute (NHBLI) Guidelines
Interventions
DRUGOmalizumab
Omalizumab was supplied as a lyophilized, sterile powder in a single-use, 5 mL vial. The vial was designed to deliver 150 mg (1.2 mL) of omalizumab for subcutaneous (s.c.) administration after reconstitution with 1.4 mL sterile water for injection. Doses of more than 150 mg were divided among multiple injection sites to limit injections to not more than 150 mg per site.
DRUGPlacebo
Placebo was supplied as a lyophilized, sterile powder in a single-use, 5 mL vial. The vial was designed to deliver 150 mg (1.2 mL) of placebo for subcutaneous (s.c.) administration after reconstitution with 1.4 mL sterile water for injection. Doses of more than 150 mg were divided among multiple injection sites to limit injections to not more than 150 mg per site.
Sponsors
Genentech, Inc.
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Total Asthma Control Test (ACT) score of ≤19 plus at least one of the following in the 4 weeks preceding visit 1, on average: * Symptoms \> 2 days/week * Night-time awakenings ≥1 time/week * Short-acting beta2-agonist (SABA) use for symptom control \>2 days/week forced expiratory volume in 1 second (FEV1) ≤ 80% predicted
Exclusion criteria
* History of intubation for asthma. * An asthma exacerbation requiring treatment with systemic steroids within 4 weeks of screening (Visit 1). * Less than 3 months of stable maintenance oral corticosteroid therapy for asthma Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Asthma Control Test (ACT) After 24 Weeks of Treatment | Baseline and 24 weeks | The Asthma Control Test (ACT) is a validated tool to assess overall asthma control over the last 4 weeks in patients aged \>= 12 years old. It is a 1 page questionnaire consisting of 5 simple questions assessing: asthma symptoms, use of rescue medications, and the impact of asthma on everyday functioning. All questions are scored on a 5-point Likert scale, with a higher score indicating better control. All scores are added together to calculate a total score. Total score ranges from 5 to 25. A positive change indicates improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Investigator Global Evaluation of Treatment Effectiveness (IGETE) at 24 Weeks | 24 weeks | The IGETE is an assessment of asthma symptom control in response to asthma treatment. It consists of the question What is the investigator's overall impression of the study medication and its effect on the typical symptoms of allergic asthma during the study? The scale is: excellent, good, moderate, poor, and worsening. A good or excellent response is suggested as a means of defining a patient who has responded to treatment. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Omalizumab The determined dose (at least 0.016 mg/kg/IgE (IU/mL) was administered subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used. | 136 |
| Placebo Placebo was administered subcutaneously every 2 weeks or every 4 weeks depending on the dosing schedule in the protocol. | 135 |
| Total | 271 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 3 |
| Overall Study | Lost to Follow-up | 5 | 1 |
| Overall Study | Protocol Deviation | 2 | 2 |
| Overall Study | Withdrawal by Subject | 6 | 7 |
Baseline characteristics
| Characteristic | Omalizumab | Placebo | Total |
|---|---|---|---|
| Age Continuous | 41.9 years STANDARD_DEVIATION 14.6 | 40.7 years STANDARD_DEVIATION 14.85 | 41.3 years STANDARD_DEVIATION 14.71 |
| Sex: Female, Male Female | 93 Participants | 87 Participants | 180 Participants |
| Sex: Female, Male Male | 43 Participants | 48 Participants | 91 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 52 / 136 | 51 / 135 |
| serious Total, serious adverse events | 3 / 136 | 5 / 135 |
Outcome results
Primary
Change From Baseline in Asthma Control Test (ACT) After 24 Weeks of Treatment
The Asthma Control Test (ACT) is a validated tool to assess overall asthma control over the last 4 weeks in patients aged \>= 12 years old. It is a 1 page questionnaire consisting of 5 simple questions assessing: asthma symptoms, use of rescue medications, and the impact of asthma on everyday functioning. All questions are scored on a 5-point Likert scale, with a higher score indicating better control. All scores are added together to calculate a total score. Total score ranges from 5 to 25. A positive change indicates improvement.
Time frame: Baseline and 24 weeks
Population: The Full Analysis Set consisted of patients to whom study drug had been assigned through randomization. Patients inappropriately randomized were excluded from this analysis set.~Participants with observations at both baseline and 24 weeks were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omalizumab | Change From Baseline in Asthma Control Test (ACT) After 24 Weeks of Treatment | 5.2 Score on a scale | Standard Deviation 4.37 |
| Placebo | Change From Baseline in Asthma Control Test (ACT) After 24 Weeks of Treatment | 4.7 Score on a scale | Standard Deviation 4.01 |
Secondary
Investigator Global Evaluation of Treatment Effectiveness (IGETE) at 24 Weeks
The IGETE is an assessment of asthma symptom control in response to asthma treatment. It consists of the question What is the investigator's overall impression of the study medication and its effect on the typical symptoms of allergic asthma during the study? The scale is: excellent, good, moderate, poor, and worsening. A good or excellent response is suggested as a means of defining a patient who has responded to treatment.
Time frame: 24 weeks
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Omalizumab | Investigator Global Evaluation of Treatment Effectiveness (IGETE) at 24 Weeks | Excellent | 26 participants |
| Omalizumab | Investigator Global Evaluation of Treatment Effectiveness (IGETE) at 24 Weeks | Good | 44 participants |
| Omalizumab | Investigator Global Evaluation of Treatment Effectiveness (IGETE) at 24 Weeks | Moderate | 29 participants |
| Omalizumab | Investigator Global Evaluation of Treatment Effectiveness (IGETE) at 24 Weeks | Poor | 27 participants |
| Omalizumab | Investigator Global Evaluation of Treatment Effectiveness (IGETE) at 24 Weeks | Worsening | 1 participants |
| Omalizumab | Investigator Global Evaluation of Treatment Effectiveness (IGETE) at 24 Weeks | Missing | 9 participants |
| Placebo | Investigator Global Evaluation of Treatment Effectiveness (IGETE) at 24 Weeks | Worsening | 2 participants |
| Placebo | Investigator Global Evaluation of Treatment Effectiveness (IGETE) at 24 Weeks | Excellent | 19 participants |
| Placebo | Investigator Global Evaluation of Treatment Effectiveness (IGETE) at 24 Weeks | Poor | 36 participants |
| Placebo | Investigator Global Evaluation of Treatment Effectiveness (IGETE) at 24 Weeks | Good | 44 participants |
| Placebo | Investigator Global Evaluation of Treatment Effectiveness (IGETE) at 24 Weeks | Missing | 4 participants |
| Placebo | Investigator Global Evaluation of Treatment Effectiveness (IGETE) at 24 Weeks | Moderate | 30 participants |