Omalizumab in Adult and Adolescent Patients With Severe Persistent Allergic Asthma

Novartis

Status and phase: Completed; Phase 4

Conditions: Asthma

Treatments: Other: Optimized asthma therapy; Drug: Omalizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00264849

CIGE025A2425

Details and patient eligibility

About

Omalizumab will be given as add-on treatment to optimized asthma therapy in patients with severe persistent asthma, who demonstrate inadequate asthma symptom control. Response to omalizumab over time will be assessed by physicians and patients evaluating the overall improvement in control of their asthma.

THIS STUDY IS NOT ENROLLING PATIENTS IN THE US.

Enrollment: 406 patients

Sex: All

Ages: 12 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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406 participants in 2 patient groups

OAT + Omalizumab

Experimental group

Description:

During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.

Treatment:

Other: Optimized asthma therapy

Drug: Omalizumab

Optimized Asthma Treatment (OAT)

Active Comparator group

Description:

During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for 32 weeks.

Treatment:

Other: Optimized asthma therapy