A randomized, multi-center, double-blind, placebo-controlled, parallel-group trial to explore the effects of 78 weeks omalizumab treatment as add on therapy on airway inflammation and remodeling in patients with moderate to severe IgE-mediated asthma receiving inhaled corticosteroids and long acting beta-agonists
- Conditions
- Asthma
- Registration Number
- EUCTR2007-004653-29-DE
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 96
1. patients who have been informed of the study procedures and medications and have given written informed consent
2. who are 18 - 75 years of age and are considered fit to undergo bronchoscopy by the investigator
3. with a body weight = 20 kg and = 150 kg and with a serum total IgE level = 30 to = 700 IU/ml. The combination of body weight and serum total IgE level must fall within the dosing cells of the approved European dosing tables (Table 6-1 and 6-2)
4. patients with moderate to severe allergic asthma, with persistent symptoms despite receiving an inhaled corticosteroid and long acting beta-agonist (i.e. Step 4 or 5 treatment as per 2006 GINA guidelines – Appendix 3)
5. with = 2% eosinophilia in induced sputum at visits 1 and 2
6. with a positive skin prick test (diameter of wheal = 3 mm) or RAST test to at least one perennial aeroallergen, excluding molds (eg. dust mite, cat/dog dander, cockroaches), documented within the past 2 years or demonstrated at Visit 1, to which the patient will be exposed on a regular basis (most days) for the duration of
the study.
7. A RAST test may be performed for patients with a borderline skin prick test result. Patients with a total IgE level of = 76 IU/mL require an unequivocal positive RAST test (>71 IU/mL; Class 2+) to be eligible. Skin prick test procedures can be found in Appendix 6
8. with a post-bronchodilator FEV1 =60% of the predicted normal value for the patient, demonstrable 15 minutes after the patient receives 400mcg of salbutamol (or equivalent), at Visit 1. FEV1 % predicted must be stable (within 10%) at the second screening visit (Visit 2) and the randomization visit (Visit 3)
9. receiving moderate to high dose inhaled corticosteroid = 800µg per day BDP or equivalent, as monotherapy or fixed dose combination, and a regular inhaled long acting ß-2 agonist at stable doses for at least 3 months prior to
screening
Are the trial subjects under 18? no
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
1. Female of childbearing potential (more details are provided in the protocol)
2. Patients under other therapies/medications:
• who do not adhere to the following antihistamine washout prior to the skin prick tests at Visit 1 (short and medium acting antihistamines may be used during the study, but wash out is required prior to the skin prick testing):
- short acting antihistamines (e.g.: chlorpheniramine, promethazine, diphenhydramine, terfenadine) within 3 days of Visit 1
- medium acting antihistamines (e.g.: loratadine, cetirizine, fexofenadine) within 5 days of Visit 1
• who are receiving:
- ß adrenergic antagonist medication (e.g.: propranolol) or anticipate use during the study
- methotrexate, gold salts, cyclosporin or troleandomycin within 3 months of Visit 1 or anticipate their use during the study
- desensitization therapy with less than 3 months of stable maintenance doses prior to the screening visit (Visit 1)
- who have received omalizumab previously
3. Concurrent diseases/conditions and history of other diseases/conditions as detailled in the protocol
4. Investigational drug/therapy use as detailled in the protocol
5. Ingredient hypersensitivity as detailled in the protocol
6. Compliance, reliability and investigator judgment as detailled in the protocol
7. Exclusion criteria for flexible fiberoptic bronchoscopy as detailled in the protocol (additional exclusion criteria added in the Protocol amendment 02)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method