Mannitol Bronchoprovocation Challenge Ancillary Study/ACRN

University of Wisconsin (UW)

Status and phase: Completed; Early Phase 1

Conditions: Asthma

Treatments: Drug: mannitol

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT00585260

144QK18

H-2007-0071

Details and patient eligibility

About

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

Enrollment: 66 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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66 participants in 1 patient group

Exploratory Mannitol

Experimental group

Description:

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

Treatment:

Drug: mannitol