Severe persistent allergic asthma MedDRA version: 8.1 Level: LLT Classification code 10001705 Term: Allergic asthma
Conditions
Interventions
Product Name: Xolair
Product Code: omalizumab
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: omalizumab
Current Sponsor code: IGE025
Concentration unit: mg milligram(s)
Co
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - males or females of any race who are 12-75 years of age - body weight 20 to 150 kg and total serum IgE level 30 to 700 IU/ml - diagnosis of allergic asthma =1 year duration according to ATS criteria and at screening a history consistent with GINA step 3 or 4 clinical features - positive skin prick test to at least one perennial allergen documented within the past 2 years or taken at Visit 1. Patients with a total IgE level of = 76 IU require an unequivocal positive RAST test to be eligible - demonstrating at least 12% increase in FEV1 within 30 minutes of taking salbutamol - FEV1 between 40 and 80% of the predicted normal value for the patient at screening and randomization - receiving high dose inhaled corticosteroid = 800µg BDP or equivalent and a regular inhaled long acting beta-2 agonist for at least 3 months prior to screening and > 1000 µg BDP and a LABA for at least 4 weeks during the run-in and at randomization - who have suffered at least two independent documented severe asthma exacerbations while receiving high doses of ICS (= 800 µg BDP or equivalent) plus regular inhaled LABA requiring treatment with systemic (oral or IV) corticosteroids. Qualifying exacerbations must have taken place in the 3 years prior to screening, and at least one severe exacerbation must have occurred within the previous 12 months - with evidence of poor asthma control at screening and for at least 4 weeks immediately prior to randomization Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - pregnant or nursing women, and women of childbearing potential unless they meet the definition of post-menopausal or use one or more acceptable methods of contraception Patients : - who, for reasons other than asthma, have received systemic corticosteroids within 4 weeks of Visit 1 or are likely to require it during the study for reasons other than asthma - not adhering to the antihistamine washout prior to the skin prick tests at Visit 1 - taking ß adrenergic antagonist medication or anticipate use during the study - taking methotrexate, gold salts, cyclosporin or troleandomycin within 3 months of Visit 11 (or anticipated their use during the study) - currently receiving desensitization therapy with less than 3 months of stable maintenance doses prior to the screening visit (Visit 1) - foreseen to require additional asthma medication during the last 4 weeks of the run-in period - being treated for an asthma exacerbation during the 4 weeks immediately prior to randomization - with a smoking history > 10 pack years or an active lung disease other than allergic asthma, e.g. COPD - with elevated serum IgE levels for reasons other than allergy - with significant underlying medical conditions that could impact interpretation of results should be excluded (e.g.: infection, hematological disease, malignancy, renal, hepatic, coronary heart disease or other cardiovascular disease, endocrinologic or gastrointestinal disease) within the previous 3 months - who have previously been randomized into this or any other omalizumab study or who have received omalizumab (prescribed)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate persistency in treatment responder classification between assessments at 16 and 32 weeks after starting omalizumab therapy given as add on to optimized asthma therapy in patients who remain uncontrolled despite GINA step 4 therapy. Treatment response is defined by at least marked improvement of overall asthma control as assessed by physician global evaluation of treatment effectiveness.;Secondary Objective: * To evaluate persistency in treatment responder classification between assessments at 16 and 32 weeks after randomization to optimized asthma therapy alone in patients who remain uncontrolled despite GINA step 4 therapy. * To evaluate the effect of omalizumab as add-on to optimized asthma therapy compared to optimized asthma therapy alone (GETE, FEV1, rate of exacerbations, Asthma Control Questionnaire and meaningful nighttime awakenings, rate of hospitalizations for exacerbations, reduction of OCS dose, QOL, Work Productivity, Activity Impairment : see details in full protocol) * To further evaluate the best individual or combination of clinical measures for evaluating treatment response to omalizumab treatment Exploratory : Evaluation of response rate to omalizumab treatment compared to previous double blind trial, Fractional Exhaled Nitric Oxide as non-invasive measure of airway inflammation in a subgroup of patients;Primary end point(s): The primary variable, persistency rate (%) of response, is based on the investigator’s global evaluation of treatment effectiveness, dichotomized to responders (excellent or good) and non-responders (moderate, poor or worsening) for patients receiving omalizumab as add on to optimal asthma therapy, assessed at week 16 and week 32. | — |
Countries
Belgium, Denmark, Germany, Greece, Hungary, Ireland, Italy, Portugal, Spain, Sweden, United Kingdom
Outcome results
None listed