Effect of Xolair on Airway Hyperresponsiveness
Part of paid clinical trials in Omaha, Nebraska.
- Sponsor
- Creighton University
- Study ID
- NCT00208234
- Phase
- PHASE4
- Status
- Unknown
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 19 Years - 50 Years
- Healthy Volunteers
- Not accepted
Interventions
- Omalizumab — DRUG0.016 mg/kg IgE
- Placebo for Omalizumab — DRUGPlacebo
- omalizumab — DRUGMonoclonal antibody against IgE. 0.016 mg/kg IgE
Study Details
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.
Key Dates
- Start date
- Jan 31, 2004
- Status verified
- Sep 2011
- Primary completion
- Sep 30, 2011
- Completion
- Sep 30, 2011
Study Design
- Enrollment
- 22 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Placebo Comparator: ControlPlacebo
- Experimental: 2Omalizumab
Primary Outcome 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 ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Creighton University Division of Allergy & Immunology | Omaha | Nebraska | 68131 | - |
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