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Completed

NCT Number: NCT00585260

Mannitol Bronchoprovocation Challenge Ancillary Study/ACRN

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

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

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

Madison, Wisconsin, 53792, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mannitol

Drug

indirect mannitol challenge

Primary outcomes

  1. Incidence of Adverse Events

    Time frame: 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 outcomes

  1. Correlation of the baseline PD15FEV1 with other baseline physiologic measurements collected in the BASALT trial

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • Syntara

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Jan 3, 2008
Registry last updated
Aug 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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