Trial Outcomes & Findings for Omalizumab Use and Asthma-Related Quality of Life in Patients With Severe Persistent Allergic Asthma (NCT NCT00567476)

NCT ID: NCT00567476

Last Updated: 2011-06-30

Results Overview

The AQLQ was administered to all patients at Baseline, Week 12 and Week 20. The 32 questions in the AQLQ were divided into four domains; activity limitations, symptoms, emotional function, and environmental stimuli. Individual questions are equally weighted. The overall AQLQ score is the mean of the responses to each of the 32 questions, and ranges from 1 to 7. A score 7.0 indicates that the patient has no impairments due to asthma and a score of 1.0 indicates severe impairment.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 116 participants
• Primary outcome timeframe: Baseline and Week 20
• Results posted on: 2011-06-30

Participant Flow

Participant milestones

Measure	Omalizumab + Conventional Therapy Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.	Conventional Therapy Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
Overall Study STARTED	78	38
Overall Study COMPLETED	70	34
Overall Study NOT COMPLETED	8	4

Reasons for withdrawal

Measure	Omalizumab + Conventional Therapy Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.	Conventional Therapy Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
Overall Study Adverse Event	2	0
Overall Study Pregnancy	1	0
Overall Study Protocol Violation	4	1
Overall Study Lost to Follow-up	0	1
Overall Study Administrative issues	1	0
Overall Study Medical Decision	0	1
Overall Study Non-adherence to protocol	0	1

Baseline Characteristics

Omalizumab Use and Asthma-Related Quality of Life in Patients With Severe Persistent Allergic Asthma

Baseline characteristics by cohort

Measure	Omalizumab + Conventional Therapy n=78 Participants Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.	Conventional Therapy n=38 Participants Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.	Total n=116 Participants Total of all reporting groups
Age, Customized > 12 years and < 25 years	4 Participants 13.1 • n=5 Participants	4 Participants 12.8 • n=7 Participants	8 Participants n=5 Participants
Age, Customized ≥ 25 and < 35 years	15 Participants n=5 Participants	3 Participants n=7 Participants	18 Participants n=5 Participants
Age, Customized ≥ 35 and < 55 years	42 Participants n=5 Participants	23 Participants n=7 Participants	65 Participants n=5 Participants
Age, Customized ≥ 55 and < 65 years	12 Participants n=5 Participants	4 Participants n=7 Participants	16 Participants n=5 Participants
Age, Customized ≥ 65 and < 75 years	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Female	60 Participants n=5 Participants	29 Participants n=7 Participants	89 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	9 Participants n=7 Participants	27 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Week 20

Population: Patients who took at least one dose of double-blind study drug and who had at least one post-baseline safety or efficacy assessment made up the intent-to treat (ITT) population. Last observation carried forward (LOCF) approach was used. Scores of completed AQLQ at Week 12 were used at Week 20 for dropped out patients or for missing values.

The AQLQ was administered to all patients at Baseline, Week 12 and Week 20. The 32 questions in the AQLQ were divided into four domains; activity limitations, symptoms, emotional function, and environmental stimuli. Individual questions are equally weighted. The overall AQLQ score is the mean of the responses to each of the 32 questions, and ranges from 1 to 7. A score 7.0 indicates that the patient has no impairments due to asthma and a score of 1.0 indicates severe impairment.

Outcome measures

Measure	Omalizumab + Conventional Therapy n=78 Participants Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.	Conventional Therapy n=38 Participants Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
The Mean Change From Baseline to Week 20 in the Overall Asthma Quality of Life Questionnaire (AQLQ) Baseline (n=77, 37)	3.1 Units on a scale Standard Error 1.0	3.1 Units on a scale Standard Error 1.1
The Mean Change From Baseline to Week 20 in the Overall Asthma Quality of Life Questionnaire (AQLQ) At Week 20 (n=78, 36)	4.4 Units on a scale Standard Error 1.4	3.0 Units on a scale Standard Error 1.1
The Mean Change From Baseline to Week 20 in the Overall Asthma Quality of Life Questionnaire (AQLQ) Change from baseline to week 20 (n=77, 36)	1.2 Units on a scale Standard Error 0.1	-0.1 Units on a scale Standard Error 0.1

SECONDARY outcome

Timeframe: Baseline and Week 20

Population: Patients who took at least one dose of double-blind study drug and who had at least one post-baseline safety or efficacy assessment made up the intent-to treat (ITT) population. Last observation carried forward (LOCF) approach was used. Scores of completed AQLQ at Week 12 were used at Week 20 for dropped out patients or for missing values.

The AQLQ was administered to all patients at Baseline, Week 12 and Week 20. The 32 questions in the AQLQ were divided into four domains; activity limitations, symptoms, emotional function, and environmental stimuli. Individual questions are equally weighted. The overall AQLQ score is the mean of the responses to each of the 32 questions and ranges from 1 to 7. A score 7.0 indicates that the patient has no impairments due to asthma and score 1.0 indicates severe impairment.

Outcome measures

Measure	Omalizumab + Conventional Therapy n=77 Participants Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.	Conventional Therapy n=36 Participants Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
Percentage of Participants With an Increase of More Than 1.5 in AQLQ Overall Score at 20 Weeks	40.3 Percentage of participants Interval 30.0 to 51.4	2.8 Percentage of participants Interval 0.5 to 14.2

SECONDARY outcome

Timeframe: Baseline and Week 20

Population: Patients who took at least one dose of double-blind study drug and who had at least one post-baseline safety or efficacy assessment made up the intent-to treat (ITT) population. Last observation carried forward (LOCF) approach was used. Scores of completed AQLQ at Week 12 were used at Week 20 for dropped out patients or for missing values.

The AQLQ was administered to all patients at Baseline, Week 12 and Week 20. The 32 questions in the AQLQ were divided into four domains; activity limitations, symptoms, emotional function, and environmental stimuli. Individual questions are equally weighted. The overall AQLQ score is the mean of the responses to each of the 32 questions and ranges from 1 to 7. AQLQ of each domain is the mean of the responses to each of the questions within that domain. A score 7.0 indicates that the patient has no impairments due to asthma and score 1.0 indicates severe impairment.

Outcome measures

Measure	Omalizumab + Conventional Therapy n=77 Participants Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.	Conventional Therapy n=36 Participants Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
Percentage of Participants With an Increase of More Than 0.5 in AQLQ Overall Score at Week 20	70.1 Percentage of participants Interval 59.2 to 79.2	22.2 Percentage of participants Interval 11.7 to 38.1

SECONDARY outcome

Timeframe: Baseline and Week 20

Population: Patients who took at least one dose of double-blind study drug and who had at least one post-baseline safety or efficacy assessment made up the intent-to treat (ITT) population. Last observation carried forward (LOCF) approach was used. Scores of completed AQLQ at Week 12 were used at Week 20 for dropped out patients or for missing values.

AQLQ was administered to all patients at Baseline, Week 12 and Week 20, and prior to any clinic visit evaluation and drug administration.

The 32 questions in the AQLQ were divided into four domains: activity limitations, symptoms, emotional function, and environmental stimuli. AQLQ domain scores were calculated by adding the responses to each of the questions in the domain and dividing by the number of questions in the domain. Each domain score was between 1 and 7. Score 7.0 meant that the patient had no impairments due to asthma and score 1.0 indicated severe impairment.

Outcome measures

Measure	Omalizumab + Conventional Therapy n=78 Participants Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.	Conventional Therapy n=38 Participants Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
The Mean Change From Baseline to the End of Study in AQLQ Domain Score Activity limitation score	1.3 Units on a scale Standard Error 0.1	-0.2 Units on a scale Standard Error 0.1
The Mean Change From Baseline to the End of Study in AQLQ Domain Score Symptoms score	1.2 Units on a scale Standard Error 0.2	-0.2 Units on a scale Standard Error 0.2
The Mean Change From Baseline to the End of Study in AQLQ Domain Score Emotional function score	1.3 Units on a scale Standard Error 0.2	0.0 Units on a scale Standard Error 0.1
The Mean Change From Baseline to the End of Study in AQLQ Domain Score Environmental stimuli score	1.2 Units on a scale Standard Error 0.2	0.0 Units on a scale Standard Error 0.2

SECONDARY outcome

Timeframe: From Baseline through 20 weeks

Population: All randomized patients who took at least one dose of double-blind study medication and who had at least one post-baseline safety or efficacy assessment made up the ITT population.

For the purpose of evaluating efficacy, a clinically significant asthma exacerbation was defined as a worsening of asthma symptoms as judged clinically by the investigator, requiring doubling the baseline ICS dose for at least 3 days and/or treatment with rescue systemic (oral or IV) corticosteroids. The initiation of the above corticosteroid regimens marked the start of an asthma exacerbation episode and cessation of the additional corticosteroid regimens marked the end of an exacerbation episode.

Outcome measures

Measure	Omalizumab + Conventional Therapy n=78 Participants Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.	Conventional Therapy n=38 Participants Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
Number of Asthma Exacerbation Episodes Per Participant Patients with 1 episode	25 Participants	12 Participants
Number of Asthma Exacerbation Episodes Per Participant Patients with 2 episodes	5 Participants	6 Participants
Number of Asthma Exacerbation Episodes Per Participant Patients with 3 episodes	3 Participants	1 Participants
Number of Asthma Exacerbation Episodes Per Participant Patients with 4 episodes	1 Participants	1 Participants
Number of Asthma Exacerbation Episodes Per Participant Total number of patients with episodes	34 Participants	20 Participants

SECONDARY outcome

Timeframe: From Baseline through 20 Weeks

Population: All randomized patients who took at least one dose of double-blind study medication and who had at least one post-baseline safety or efficacy assessment made up the intention-to-treat (ITT) population.

When necessary, patients were allowed to take rescue medication using inhaled salbutamol or terbutaline for symptoms of intercurrent bronchospasm.

Outcome measures

Measure	Omalizumab + Conventional Therapy n=78 Participants Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.	Conventional Therapy n=38 Participants Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
Percentage of Participants Using Rescue Medication	43.6 Percentage of participants Interval 33.1 to 54.6	44.7 Percentage of participants Interval 30.1 to 60.3

SECONDARY outcome

Timeframe: From Baseline through 20 weeks (140 days)

Population: All randomized patients who took at least one dose of double-blind study medication and who had at least one post-baseline safety or efficacy assessment made up the intention-to-treat (ITT) population.

When necessary, patients were allowed to take rescue medication using inhaled salbutamol or terbutaline for symptoms of intercurrent bronchospasm. Days with no rescue medication intake were the variable of interest for this analysis.

Outcome measures

Measure	Omalizumab + Conventional Therapy n=78 Participants Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.	Conventional Therapy n=38 Participants Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
Free Days With no Rescue Medication	73.5 Days Standard Deviation 39.4	74.9 Days Standard Deviation 35.4

SECONDARY outcome

Timeframe: From Baseline through 20 Weeks

Population: All randomized patients who took at least one dose of double-blind study medication and who had at least one post-baseline safety or efficacy assessment made up the intention-to-treat (ITT) population. Number of patients analyzed includes only those patients requiring rescue medication during the study.

When necessary, patients were allowed to take rescue medication using inhaled salbutamol or terbutaline for symptoms of intercurrent bronchospasm. The number of puffs taken during each 24 hour period was recorded in the patient dairy. The total number of puffs over 20 weeks of treatment was divided by the number of treatment days (140 days) to calculate the mean number of puffs per day.

Outcome measures

Measure	Omalizumab + Conventional Therapy n=34 Participants Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.	Conventional Therapy n=17 Participants Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
Mean Number of Puffs of Rescue Medication Taken Per Day	5.5 Puffs Standard Deviation 4.1	6.4 Puffs Standard Deviation 4.7

SECONDARY outcome

Timeframe: 20 Weeks

Population: All randomized patients who took at least one dose of double-blind study medication and who had at least one post-baseline safety or efficacy assessment made up the intention-to-treat (ITT) population.

At the end of Week 20 a global evaluation of the treatment effectiveness was performed by the investigator using the following scale: Excellent: complete control of asthma; Good: marked improvement of asthma; Moderate: discernible, but limited improvement in asthma; Poor: no appreciable change in asthma; Worsening of asthma

Outcome measures

Measure	Omalizumab + Conventional Therapy n=76 Participants Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.	Conventional Therapy n=37 Participants Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
Physician's Global Assessment of Treatment Effectiveness Excellent	22 Participants	2 Participants
Physician's Global Assessment of Treatment Effectiveness Good	35 Participants	4 Participants
Physician's Global Assessment of Treatment Effectiveness Moderate	13 Participants	11 Participants
Physician's Global Assessment of Treatment Effectiveness Poor	6 Participants	18 Participants
Physician's Global Assessment of Treatment Effectiveness Worsening	0 Participants	2 Participants

SECONDARY outcome

Timeframe: 20 Weeks

Population: All randomized patients who took at least one dose of double-blind study medication and who had at least one post-baseline safety or efficacy assessment made up the ITT population.

At the end of Week 20, a global evaluation of the treatment effectiveness was performed by the patient using the following scale:

Excellent: complete control of asthma; Good: marked improvement of asthma; Moderate: discernible, but limited improvement in asthma; Poor: no appreciable change in asthma; Worsening of asthma

Outcome measures

Measure	Omalizumab + Conventional Therapy n=76 Participants Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.	Conventional Therapy n=37 Participants Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
Patient's Global Assessment of Treatment Effectiveness Poor	3 Participants	9 Participants
Patient's Global Assessment of Treatment Effectiveness Excellent	33 Participants	3 Participants
Patient's Global Assessment of Treatment Effectiveness Good	30 Participants	13 Participants
Patient's Global Assessment of Treatment Effectiveness Moderate	10 Participants	10 Participants
Patient's Global Assessment of Treatment Effectiveness Worsening	0 Participants	2 Participants

Adverse Events

Omalizumab + Conventional Therapy

Serious events: 3 serious events

Other events: 42 other events

Deaths: 0 deaths

Conventional Therapy

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Measure	Omalizumab + Conventional Therapy n=78 participants at risk Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.	Conventional Therapy n=38 participants at risk Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
Pregnancy, puerperium and perinatal conditions Pregnancy	1.3% 1/78	0.00% 0/38
Respiratory, thoracic and mediastinal disorders Pneumonia	1.3% 1/78	0.00% 0/38
Respiratory, thoracic and mediastinal disorders Pneumothorax	1.3% 1/78	0.00% 0/38

Other adverse events

Measure	Omalizumab + Conventional Therapy n=78 participants at risk Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.	Conventional Therapy n=38 participants at risk Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
General disorders Pyrexia	5.1% 4/78	0.00% 0/38
Injury, poisoning and procedural complications Joint sprain	5.1% 4/78	0.00% 0/38
Musculoskeletal and connective tissue disorders Back pain	10.3% 8/78	2.6% 1/38
Nervous system disorders Headache	20.5% 16/78	10.5% 4/38
Psychiatric disorders Anxiety	5.1% 4/78	2.6% 1/38
Reproductive system and breast disorders Dysmenorrhoea	1.3% 1/78	5.3% 2/38
Respiratory, thoracic and mediastinal disorders Nasopharyngitis	7.7% 6/78	0.00% 0/38
Respiratory, thoracic and mediastinal disorders Respiratory tract infection	10.3% 8/78	7.9% 3/38
Respiratory, thoracic and mediastinal disorders Rhinitis	3.8% 3/78	10.5% 4/38
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	1.3% 1/78	5.3% 2/38
Respiratory, thoracic and mediastinal disorders Sinusitis	12.8% 10/78	5.3% 2/38
Respiratory, thoracic and mediastinal disorders Upper respiratory tract infection	6.4% 5/78	7.9% 3/38
Skin and subcutaneous tissue disorders Pruritus	6.4% 5/78	5.3% 2/38

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862 778-8300

Results disclosure agreements

• Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
• Publication restrictions are in place

Restriction type: OTHER