Mannitol Bronchoprovocation Challenge Ancillary Study/ACRN

Early Phase 1CompletedNCT00585260

University of Wisconsin, Madison66 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Asthma

Interventions

mannitolDRUG

indirect mannitol challenge

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Wisconsin Madison Department of Asthma, Allergy and Pulmonary Clinical Research

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

Incidence of Adverse Events

Mannitol bronchoprovocation challenge testing is safe, effective and well tolerated as compared to methacholine (conducted as part of the main BASALT trial).

Time frame: At 6 weeks, 20 weeks, and 32 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.