Status:
COMPLETED
Efficacy/ Safety of Omalizumab in Patients With Seasonal Allergic Asthma and Seasonal Allergic Rhinoconjunctivitis
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Allergic Asthma
Eligibility:
All Genders
12-45 years
Phase:
PHASE3
Brief Summary
Efficacy/ safety for the combination of anti-IgE (Omalizumab) and specific immunotherapy (Depigoid) in patients with not adequately controlled seasonal allergic asthma and comorbid seasonal allergic r...
Detailed Description
This was an open-label extension period of the previously randomized, multicenter, double-blind, placebo-controlled, parallel-group trial to demonstrate the benefit of pre- and co-seasonal combination...
Eligibility Criteria
Inclusion
- Males or females of any race who are 12-45 years of age with a body weight ≥ 20 kg and ≤ 150 kg and with a total serum IgE level ≥ 30 to ≤ 700 IU/ml (suitable weight for dosing)
- Patients with the diagnosis of not adequately controlled seasonal grass pollen (and/or rye pollen) and allergic asthma with concomitant seasonal allergic rhinoconjunctivitis within \> 2 previous seasons
- patients with a positive RAST (\>CAP2) result for grass pollen (and/or rye pollen) specific IgE at screening (Visit 1 (V1) or within the previous 12 months.
- Patients with FEV1 \> 80% of the predicted normal value for the patient at screening \[V1\](demostrable at least 6 hours after last short acting B-2 agonist use or 12 hours after last long B-2 acting agonist use).
Exclusion
- Females of childbearing potential: pregnancy, birth control,breast-feeding
- Concurrent diseases/conditions and history of other diseases/conditions
- patients who have a positive history of significant clinical manifestations of allergy as a result of sensitization against tree pollen allergens, weed allergens and perennial allergens (e.g. Aspergillus spores, animal dander, house dust mite).
- patients with a history of food or drug related severe anaphylactoid or anaphylactic reaction(s).
- Ingredient hypersensitivity
- patients with known hypersensitivity to any ingredients, including excipients (sucrose, histidine, polysorbate 20) of the study medication, any immunotherapy, or drugs related to Omalizumab (e.g., monoclonal antibodies, polyclonal gamma globulin).
- patients with hypersensitivity to the trail's asthma rescue- or escalation-medication or related drugs.
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT00396409
Start Date
February 1 2006
End Date
August 1 2008
Last Update
March 30 2017
Active Locations (1)
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1
Novartis Investigator site
Nuremberg, Germany