Overview

This trial is active, not recruiting.

Condition allergic asthma
Treatments omalizumab, placebo for omalizumab
Phase phase 4
Sponsor Creighton University
Collaborator Genentech
Start date January 2004
End date September 2011
Trial size 22 participants
Trial identifier NCT00208234, Xolair Asthma

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Placebo Comparator)
Placebo
placebo for omalizumab
Placebo
(Experimental)
Omalizumab
omalizumab Xolair
0.016 mg/kg IgE
omalizumab Xolair
Monoclonal antibody against IgE. 0.016 mg/kg IgE

Primary Outcomes

Measure
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
time frame: post treatment

Secondary Outcomes

Measure
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
time frame: post treatment

Eligibility Criteria

Male or female participants from 19 years up to 50 years old.

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

Additional Information

Official title The Effects of Xolair (Omalizumab) on Airway Hyperresponsiveness
Principal investigator Thomas B Casale, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2011.
Information provided to ClinicalTrials.gov by Creighton University.