Effect of Xolair on Airway Hyperresponsiveness

Allergic Asthma Clinical Trial

Official title:

The Effects of Xolair (Omalizumab) on Airway Hyperresponsiveness

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00208234
• Other study ID #: Xolair Asthma
• Status: Active, not recruiting
• Phase: Phase 4
• First received: September 14, 2005
• Last updated: September 22, 2011
• Start date: January 2004
• Est. completion date: September 2011

Study information

• Verified date: September 2011
• Source: Creighton University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if Xolair can reduce the abnormal increase in limitation to airflow in patients with asthma in a relatively short time period. Another purpose is to determine if Xolair will decrease the amount of inflammation in the lungs of an asthmatic patient in the same time period.

Description:

Xolair, a recombinant humanized monoclonal anti-IgE antibody, has been studied extensively and proven efficacious in the treatment of asthma and other allergic disorders. In moderate to severe allergic asthmatic patients, Xolair reduced asthma exacerbations and improved symptoms. However, there is limited data on the effects of Xolair on airway hyperreactivity, an important component of asthma.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 22
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 50 Years

Eligibility

Inclusion Criteria:

• Female patients must have a negative urine pregnancy test at Visit 1 and a negative urine pregnancy test at subsequent visits. In addition, female patients must be using a medically acceptable form of birth control.

• History of mild to moderate asthma

• A positive skin prick test to one or more perennial environmental allergens (dog, cat, dermatophagoides farinae, or dermatophagoides pteronyssinus)

• A PC20 value for methacholine < 5 mg/mL

• A PC15 value for hypertonic saline at < 4 minutes

• Capable of faithfully attending regularly scheduled study visits

• Willing to avoid prohibited medications for the periods indicated in the protocol

• A baseline serum IgE level of > 30 IU/mL and < 700 IU/mL

Exclusion Criteria:

• Women of childbearing potential not using a medically acceptable form of birth control, as well as women who are breastfeeding

• Known sensitivity to study drug or class of study drug

• Any sinus, middle ear, oropharyngeal, upper or lower respiratory tract infection that has not resolved at least 2 weeks prior to the screening visit, or for which antibiotic therapy has not been completed at least 2 weeks prior to the screening visit

• Patients with a history of severe anaphylactoid or anaphylactic reactions

• Patients taking beta-adrenergic antagonists in any form

• Patients previously exposed to Xolair

• Patients with a known hypersensitivity to trial drug excipient ingredients or related drugs

• Chronic or intermittent use of inhaled, oral, intranasal, intramuscular, or intravenous corticosteroids, or use of topical corticosteroids other than intermittent use of low potency preparations

• Use of immunosuppressive medications

• History or presence of significant renal, hepatic, neurologic, cardiovascular, hematologic, metabolic, cerebrovascular, respiratory, gastrointestinal, or other significant medical condition, including autoimmune or collagen vascular disorders aside from organ-specific autoimmune disease limited to the thyroid that in the investigator's opinion could interfere with the study or require medical treatment that would interfere with the study

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Asthma
• Respiratory Hypersensitivity

Intervention

Drug:
• Omalizumab
0.016 mg/kg IgE
• Placebo for Omalizumab
Placebo
• omalizumab
Monoclonal antibody against IgE. 0.016 mg/kg IgE

Locations

Country	Name	City	State
United States	Creighton University Division of Allergy & Immunology	Omaha	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
Creighton University	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine if treatment with omalizumab induces changes in PC20 values to methacholine bronchoprovocation challenges and/or PC15 values to hypertonic saline-induced bronchoprovocation challenges in a time-dependent manner in steroid naive subjects		post treatment	No
Secondary	Determine in steroid naive allergic asthma subjects whether omalizumab decreases exhaled NO and sputum eosinophilia, markers of airway inflammation, in time-dependent fashion and to correlate these effects with those measured for airway responsiveness		post treatment	No