Effect of Omalizumab in Patients With Severe Persistent Non-atopic Uncontrolled Asthma (NATAIR)

Novartis

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: Placebo; Drug: omalizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01007149

CIGE025AFR05

2009-010937-38 (EudraCT Number)

Details and patient eligibility

About

This study will assess the change in the expression of FcεRI receptors of blood basophils and dendritic cells after 16 weeks of treatment with omalizumab as compared with placebo, in adult patients with non-atopic severe persistent asthma, uncontrolled despite optimal therapy.

Enrollment: 79 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Severe persistent asthma with the following characteristics:

• Uncontrolled according to Global Initiative for Asthma (GINA) 2007 guidelines and at least 2 exacerbations having required systemic corticosteroid and/or at least 1 hospitalization or emergency room visit in the past year.
• Treated with high-dose inhaled corticosteroid (i.e. > 1,000 µg beclometasone dipropionate equivalent per day) plus inhaled long-acting β2 agonist (with or without maintenance oral corticosteroid).
• Non-atopic, i.e. negative blood multiallergic testing and negative Aspergillus-specific IgE-radio allergosorbent blood test and negative skin prick tests to a battery of common aeroallergens

Exclusion criteria

• Current smokers or smoking history stopped for less than 3 years or > 10 pack years.
• Asthma exacerbation during the 4 weeks prior to randomization.
• Active lung disease other than non-atopic asthma.
• Patients with an active cancer, a suspicion of cancer or any history of cancer with less than 5 disease free years.
• Pregnant or nursing (lactating) women.
• Treatment with omalizumab.

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

79 participants in 2 patient groups, including a placebo group

Omalizumab

Experimental group

Description:

Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.

Treatment:

Drug: omalizumab

Placebo

Placebo Comparator group

Description:

Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.

Treatment:

Drug: Placebo