Moderate-severe inadequately controlled Allergic Asthma
Conditions
Interventions
Trade Name: Xolair
Product Code: IGE025
Pharmaceutical Form: Powder and solvent for solution for injection
Pharmaceutical form of the placebo: Powder and solvent for solution for injection
Route of ad
Sponsors
Novartis Pharmaceuticals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Parent or legal guardian was informed of the study procedures and medications and gave written informed consent. •Outpatient males and females aged 6 - =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Patients who received systemic corticosteroids for reasons other than asthma, beta-adrenergic antagonists by any route, anticholinergics within 24 hours of Screening, methotrexate, gold salts, cyclosporin or troleandomycin, or had received desensitization therapy with less than 3 months of stable maintenance doses prior to Screening. •Patients with a history of food or drug related severe anaphylactoid or anaphylactic reaction, a history of allergy to antibiotics, with aspirin or other non-steroidal anti-inflammatory drugs (NSAID)-related asthma (unless the NSAID could be avoided), with active lung disease or acute sinusitis/chest infection, elevated serum IgE levels for other reasons, presence/history of a clinically significant uncontrolled systemic disease, cancer, abnormal, electrocardiogram (ECG) in the previous month, or platelets = 100 x 109/L or clinically significant laboratory abnormalities at Screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • Rate of Clinically Significant Asthma Exacerbations Per Patient in the 24-week Fixed-dose Steroid • Percentage of Participants With at Least 1 Adverse Event ;Secondary Objective: The secondary objectives were to assess in the studied population the effect of omalizumab compared to placebo on: a) Change in Mean Nocturnal Asthma Symptom Score From Baseline to the End (Last 4 Weeks) of the 24-week Fixed-dose Steroid Treatment Period. b)Rate of Clinically Significant Asthma Exacerbations Per Patient in the 52-week Treatment Period c) Change in Mean Daily Number of Puffs of Asthma Rescue Medication (ß2-agonist rescue medication) From Baseline to the End (Last 4 Weeks) of the 24-week Fixed-dose Steroid d) Change in Pediatric Asthma Quality of Life Questionnaire (Standardized) [PAQLQ(S)] Scores From Baseline to the End of the 24-week Fixed-dose Steroid Treatment Period (Week 24) ;Primary end point(s): a) Rate of Clinically Significant Asthma Exacerbations Per Patient in the 24-week Fixed-dose Steroid Treatment Period A clinically significant asthma exacerbation was defined as a worsening of asthma symptoms, as judged clinically by the investigator, requiring doubling of the baseline inhaled corticosteroid dose and/or treatment with systemic rescue corticosteroids for at least 3 days. The exacerbations rate per patient was derived using Poisson model adjusted by time at risk and the following covariates: country, exacerbation history, and dose schedule. A patient's person-days at risk was taken as the total amount of time (in days) he/she spent in the 24-week fixed-dose steroid treatment period. b) Percentage of Participants With at Least 1 Adverse Event;Timepoint(s) of evaluation of this end point: a) Baseline to end of the fixed-dose steroid treatment period (Week 24) b) Baseline to end of the study (Week 68) ] | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): a) Change in Mean Nocturnal Asthma Symptom Score From Baseline to the End (Last 4 Weeks) of the 24-week Fixed-dose Steroid Treatment Period. b)Rate of Clinically Significant Asthma Exacerbations Per Patient in the 52-week Treatment Period c) Change in Mean Daily Number of Puffs of Asthma Rescue Medication (ß2-agonist rescue medication) From Baseline to the End (Last 4 Weeks) of the 24-week Fixed-dose Steroid d) Change in Pediatric Asthma Quality of Life Questionnaire (Standardized) [PAQLQ(S)] Scores From Baseline to the End of the 24-week Fixed-dose Steroid Treatment Period (Week 24) ;Timepoint(s) of evaluation of this end point: a) Baseline to the end (last 4 weeks) of the 24-week fixed-dose steroid treatment period ] b) Baseline to end of the treatment period (Week 52) c) Baseline to the end (last 4 weeks) of the 24-week fixed-dose steroid treatment period ] d) Baseline to the end of the 24-week fixed-dose steroid treatment period (Week 24) ] | — |
Countries
Argentina, Brazil, Canada, Colombia, South Africa, United States
Contacts
Public ContactClinical Trial Information Desk
Novartis Pharma AG
Outcome results
None listed