Mannitol Bronchoprovocation Challenge Ancillary Study/ACRN

• Status: Completed
• Trial end date: 2010-02-16
• Target enrollment: 0
• Participant gender: All

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

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Wisconsin, Madison
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); Pharmaxis
• Treatments: Mannitol; Methacholine Chloride

Criteria

Inclusion Criteria:

• all subjects randomized to the BASALT protocol

Exclusion Criteria:

• 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