Phase 3
N=128
Efficacy/ Safety of Omalizumab in Patients With Seasonal Allergic Asthma and Seasonal Allergic Rhinoconjunctivitis
Allergic Asthma
Bottom Line
View on ClinicalTrials.gov: NCT00396409 ↗Enrolled (actual)
128
Serious AEs
4.1%
Results posted
Jun 2011
Primary outcome: Primary: Daily Symptom Load — 1.25; 1.10; 1.32; 0.97 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Depigoid (Drug); Omalizumab (Drug); Placebo (Drug)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Aug 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Daily Symptom Load |
1.25; 1.10; 1.32; 0.97 | — |
| SECONDARY Asthma/Rhinoconjunctivitis Symptom Severity Score |
0.55; 0.55; 0.54; 0.50 | — |
| SECONDARY Asthma/Rhinoconjunctivitis Rescue Medication Score |
0.70; 0.55; 0.78; 0.47 | — |
| SECONDARY Percentage of Participants by Global Evaluation of Treatment Effectiveness (GETE) Assessment Category Performed by the Investigator |
10.00; 9.09; 70.00; 54.55; 16.67; 21.82 | — |
| SECONDARY Percentage of Participants by Global Evaluation of Treatment Effectiveness (GETE) Assessment Category Performed by the Patient |
18.33; 7.27; 45.00; 50.91; 18.33; 18.18 | — |
| SECONDARY Asthma Control Questionnaire (ACQ) |
1.83; 1.97; 1.82; 1.95 | — |
| SECONDARY Asthma Quality of Life Questionnaire (AQLQ) |
6.19; 6.06; 6.22; 6.21 | — |
| SECONDARY Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) |
2.07; 2.08; 2.05; 1.98 | — |
| SECONDARY Asthma Quality of Life Questionnaire (AQLQ) and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) - Clinical Differences to Baseline |
2; 3; 4; 3; 8; 4 | — |
| SECONDARY Work Productivity and Activity Impairment |
0.00; 0.01; 0.17; 0.09; 0.17; 0.10 | — |
| SECONDARY Lung Function as Assessed by Forced Expiratory Volume in One Second (FEV1) |
3886; 3661; 3814; 3574 | — |
| SECONDARY Lung Function as Assessed by Peak Expiratory Flow (PEF) |
465.6; 441.0; 463.9; 446.1 | — |
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 rhinoconjunctivitis.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00396409). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.