Mannitol Bronchoprovocation Challenge Ancillary Study/ACRN

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00585260
Recruitment Status : Completed
First Posted : January 3, 2008
Last Update Posted : October 8, 2015
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
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
Asthma Other: guideline based dose adjustment Drug: mannitol Drug: methacholine

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Diagnostic
Official Title: Mannitol Bronchoprovocation Challenge Ancillary Study Protocol to Best Adjustment Strategy for Asthma Over Long Term
Study Start Date : December 2007
Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Mannitol
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
guideline based dose adjustment
Other: guideline based dose adjustment
standard dose adjustment
Experimental: 2
Drug: mannitol
indirect mannitol challenge
Active Comparator: 3
methacholine challenge
Drug: methacholine
methacholine challenge

Primary Outcome Measures :
  1. Mannitol bronchoprovocation challenge testing is safe, effective and well tolerated as compared to methacholine. [ Time Frame: At 6 weeks, 20 weeks, and 32 weeks. ]

Secondary Outcome Measures :
  1. To evaluate the applicability of mannitol bronchoprovocation to characterize the asthma phenotype. [ Time Frame: Baseline ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00585260

United States, Wisconsin
University of Wisconsin Madison Department of Asthma, Allergy and Pulmonary Clinical Research
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Christine A Sorkness, Pharm.D. University of Wisconsin, Madison

Responsible Party: University of Wisconsin, Madison Identifier: NCT00585260     History of Changes
Other Study ID Numbers: H-2007-0071
First Posted: January 3, 2008    Key Record Dates
Last Update Posted: October 8, 2015
Last Verified: October 2015

Keywords provided by University of Wisconsin, Madison:
bronchoprovocation challenge test

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Methacholine Chloride
Diuretics, Osmotic
Natriuretic Agents
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents
Bronchoconstrictor Agents
Respiratory System Agents
Muscarinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action