Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis
With
Genentech, Inc.
Tanox
Age
12–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients who met the following criteria were included:
Males or females of any race, who were 12-75 years of age
A body weight ≥ 20 kg and ≤ 150 kg and with a total serum IgE level ≥ 30 to ≤ 700 IU/ml
A diagnosis of allergic asthma ≥ 1 year duration according to American Thoracic Society (ATS) criteria and at screening a history consistent with GINA (2204) step 3 or 4 clinical features
A positive prick skin test (diameter of wheal \>= 3 mm) to at least one perennial allergen documented within the past 2 years or taken at visit 1
Increase in FEV1 ≥12% over baseline value within 30 minutes of taking 2 to 4 puffs (2-4x100µg) salbutamol (albuterol) or nebulized salbutamol up to 5mg
An FEV1 ≥ 40 and ≤ 80% of the predicted normal value for the patient at randomization
Receiving moderate to high dose inhaled corticosteroid ≥ 800 µg BDP or equivalent and a regular inhaled long acting B-2 agonists 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
Patients who have suffered multiple (i.e. at least two) independent documented severe asthma exacerbations while receiving high doses of ICS (≥ 800 µg BDP or equivalent) plus regular inhaled LABA
Evidence of poor asthma control at screening (based on patient history) and for at least 4 weeks immediately prior to randomisation
You may not be if
Patients who met the following criteria were excluded:
Had received systemic corticosteroids for reasons other than asthma within 4 weeks of Visit 1
A smoking history \>10 pack years
An active lung disease other than allergic asthma
Elevated serum IgE levels for reasons other than allergy
Patients with significant underlying medical conditions
Clareo Health | Omalizumab in Adult and Adolescent Patients With Severe Persistent Allergic Asthma
