Mannitol Bronchoprovocation Challenge Ancillary Study/ACRN

Sponsor

University of Wisconsin, Madison (Other)

Overall Status

Completed

CT.gov ID

NCT00585260

Collaborator

Pharmaxis (Industry), National Heart, Lung, and Blood Institute (NHLBI) (NIH)

Enrollment

Location

Arm

26.5

Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Asthma	Drug: mannitol	Early Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

66 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Mannitol Bronchoprovocation Challenge Ancillary Study Protocol to Best Adjustment Strategy for Asthma Over Long Term

Study Start Date :

Dec 1, 2007

Actual Primary Completion Date :

Feb 16, 2010

Actual Study Completion Date :

Feb 16, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Exploratory 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	Drug: mannitol indirect mannitol challenge

Arm

Intervention/Treatment

Experimental: Exploratory 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

Drug: mannitol

indirect mannitol challenge

Outcome Measures

Primary Outcome Measures

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).

Other Outcome Measures

Correlation of the baseline PD15FEV1 with other baseline physiologic measurements collected in the BASALT trial [Baseline]
To evaluate the applicability of mannitol bronchoprovocation to characterize the asthma phenotype. Correlation of the baseline PD15FEV1 with other baseline physiologic measurements and methacholine bronchoprovocation performance as collected in the BASALT trial.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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