Study to Evaluate the Effect of Xolair(Omalizumab) on Improving the Tolerability of Specific Immunotherapy in Patients With at Least Moderate Persistent Allergic Asthma Inadequately Controlled With Inhaled Corticosteroids

University of Mississippi

Status and phase: Completed; Phase 4

Conditions: Asthma

Treatments: Drug: Placebo; Drug: Xolair

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00691873

Marshall, Gailen 6 3 08

Details and patient eligibility

About

In patients with at least moderate persistent allergic asthma controlled with inhaled steroids, omalizumab (administered per US product label), when compared to placebo, will provide the participants with significantly improved tolerability of specific allergen immunotherapy (allergy shots) administered per a cluster schedule(rapid build up method).

Full description

Omalizumab is an FDA approved anti-IgE drug used to treat allergic asthma. This study is designed to give omalizumab 13 weeks prior to administering rapid build up of specific allergy shot, with an overlap of omalizumab and cluster therapy for 3 weeks. The cluster therapy will take 4 week to complete with maintenance dosage lasting an additional 6 weeks.

Enrollment: 14 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• clinical diagnosis and history of moderate persistent allergic asthma
• body weight >/= 20kg and </= 150kg
• Total serum IgE >/= 30 and </= 700IU/mL
• on a stable asthma treatment including corticosteroids for the preceding 4 weeks
• non smoker for at least 1 year prior to visit 1

Exclusion criteria

• patients with severe asthma
• history of immunotherapy to any allergen within the past 3 years
• history of anaphylactic allergic reaction
• upper respiratory tract infection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

14 participants in 2 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Placebo will be compared to Xolair 150-375 mg SQ every 2 or 4 weeks based on body weight and pre treatment IgE level.

Treatment:

Drug: Placebo

2

Experimental group

Description:

Xolair 150-375 mg SQ every 2 or 4 weeks based on body weight and pre treatment IgE level.

Treatment:

Drug: Xolair