Mannitol Bronchoprovocation Challenge Ancillary Study/ACRN
- Registration Number
- NCT00585260
- Lead Sponsor
- University of Wisconsin, Madison
- Brief Summary
This is an ancillary study conducted as part of the BASALT trial \[NCT00495157\].
The overall hypotheses are: 1) an indirect airway challenge procedure using mannitol can safely characterize asthma phenotypes, predict asthma control and exacerbations, predict responses to interventions, and perform more specifically than a direct methacholine challenge and; 2) PX27 pore function in whole blood correlates with measures of airway hyperresponsiveness induced by methacholine and/or mannitol challenges
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
- all subjects randomized to the BASALT protocol
- positive urine pregnancy test
- requirement for more than two albuterol treatments for reversal of the methacholine bronchoprovocation challenge procedure at visit 4 in the BASALT parent trial
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Exploratory Mannitol mannitol This is an exploratory / ancillary study open to all participants in the BASALT trial \[NCT00495157\] who consented to undergo mannitol bronchoprovocation procedures during the 36 week treatment period
- Primary Outcome Measures
Name Time Method Incidence of Adverse Events At 6 weeks, 20 weeks, and 32 weeks Mannitol bronchoprovocation challenge testing is safe, effective and well tolerated as compared to methacholine (conducted as part of the main BASALT trial).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Wisconsin Madison Department of Asthma, Allergy and Pulmonary Clinical Research
🇺🇸Madison, Wisconsin, United States