Trial Outcomes & Findings for Evaluate the Effect of Omalizumab on Markers of Asthma Impairment in Patients With Persistent Allergic Asthma (NCT NCT00870584)

Last Updated: 2011-11-17

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

271 participants

Primary outcome timeframe

Baseline and 24 weeks

Results posted on

2011-11-17

Participant Flow

Participant milestones

Participant milestones
Measure	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.	Placebo Placebo was administered subcutaneously every 2 weeks or every 4 weeks depending on the dosing schedule in the protocol.
Overall Study STARTED	136	135
Overall Study COMPLETED	120	122
Overall Study NOT COMPLETED	16	13

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	Placebo Placebo was administered subcutaneously every 2 weeks or every 4 weeks depending on the dosing schedule in the protocol.
Overall Study Adverse Event	3	3
Overall Study Withdrawal by Subject	6	7
Overall Study Lost to Follow-up	5	1
Overall Study Protocol Deviation	2	2

Baseline Characteristics

Evaluate the Effect of Omalizumab on Markers of Asthma Impairment in Patients With Persistent Allergic Asthma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Omalizumab n=136 Participants 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.	Placebo n=135 Participants Placebo was administered subcutaneously every 2 weeks or every 4 weeks depending on the dosing schedule in the protocol.	Total n=271 Participants Total of all reporting groups
Age Continuous	41.9 years STANDARD_DEVIATION 14.60 • n=5 Participants	40.7 years STANDARD_DEVIATION 14.85 • n=7 Participants	41.3 years STANDARD_DEVIATION 14.71 • n=5 Participants
Sex: Female, Male Female	93 Participants n=5 Participants	87 Participants n=7 Participants	180 Participants n=5 Participants
Sex: Female, Male Male	43 Participants n=5 Participants	48 Participants n=7 Participants	91 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Omalizumab n=118 Participants 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.	Placebo n=123 Participants Placebo was administered subcutaneously every 2 weeks or every 4 weeks depending on the dosing schedule in the protocol.
Change From Baseline in Asthma Control Test (ACT) After 24 Weeks of Treatment	5.2 Score on a scale Standard Deviation 4.37	4.7 Score on a scale Standard Deviation 4.01

SECONDARY outcome

Timeframe: 24 weeks

Population: Full Analysis Set

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.

Outcome measures

Outcome measures
Measure	Omalizumab n=136 Participants 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.	Placebo n=135 Participants Placebo was administered subcutaneously every 2 weeks or every 4 weeks depending on the dosing schedule in the protocol.
Investigator Global Evaluation of Treatment Effectiveness (IGETE) at 24 Weeks Worsening	1 participants	2 participants
Investigator Global Evaluation of Treatment Effectiveness (IGETE) at 24 Weeks Missing	9 participants	4 participants
Investigator Global Evaluation of Treatment Effectiveness (IGETE) at 24 Weeks Excellent	26 participants	19 participants
Investigator Global Evaluation of Treatment Effectiveness (IGETE) at 24 Weeks Good	44 participants	44 participants
Investigator Global Evaluation of Treatment Effectiveness (IGETE) at 24 Weeks Moderate	29 participants	30 participants
Investigator Global Evaluation of Treatment Effectiveness (IGETE) at 24 Weeks Poor	27 participants	36 participants

Adverse Events

Omalizumab

Serious events: 3 serious events

Other events: 52 other events

Deaths: 0 deaths

Placebo

Serious events: 5 serious events

Other events: 51 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Omalizumab n=136 participants at risk 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.	Placebo n=135 participants at risk Placebo was administered subcutaneously every 2 weeks or every 4 weeks depending on the dosing schedule in the protocol.
Blood and lymphatic system disorders Anaemia	0.74% 1/136	0.00% 0/135
Blood and lymphatic system disorders Leukocytosis	0.74% 1/136	0.00% 0/135
Cardiac disorders Pericarditis	0.74% 1/136	0.00% 0/135
General disorders Chest pain	0.74% 1/136	0.74% 1/135
Hepatobiliary disorders Cholecystitis acute	0.00% 0/136	0.74% 1/135
Infections and infestations Bronchitis bacterial	0.74% 1/136	0.00% 0/135
Infections and infestations Cellulitis	0.00% 0/136	0.74% 1/135
Infections and infestations Infected bites	0.74% 1/136	0.00% 0/135
Infections and infestations Pneumonia	0.00% 0/136	0.74% 1/135
Infections and infestations Post procedural infection	0.74% 1/136	0.00% 0/135
Infections and infestations Wound infection pseudomonas	0.00% 0/136	0.74% 1/135
Injury, poisoning and procedural complications Arthropod bite	0.74% 1/136	0.00% 0/135
Metabolism and nutrition disorders Dehydration	0.74% 1/136	0.00% 0/135
Metabolism and nutrition disorders Hyponatraemia	0.74% 1/136	0.00% 0/135
Renal and urinary disorders Renal failure acute	0.74% 1/136	0.00% 0/135
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/136	1.5% 2/135
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.74% 1/136	0.00% 0/135

Other adverse events

Other adverse events
Measure	Omalizumab n=136 participants at risk 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.	Placebo n=135 participants at risk Placebo was administered subcutaneously every 2 weeks or every 4 weeks depending on the dosing schedule in the protocol.
Infections and infestations Bronchitis	5.1% 7/136	6.7% 9/135
Infections and infestations Sinusitis	9.6% 13/136	6.7% 9/135
Infections and infestations Upper respiratory tract infection	11.0% 15/136	13.3% 18/135
Nervous system disorders Headache	5.1% 7/136	6.7% 9/135
Respiratory, thoracic and mediastinal disorders Asthma	14.7% 20/136	18.5% 25/135

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 (i.e., data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER