Mannitol Bronchoprovocation Challenge Ancillary Study/ACRN - Full Text View

Sponsors and Collaborators:	University of Wisconsin, Madison Pharmaxis National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00585260

Purpose

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	Intervention
Asthma	Other: guideline based dose adjustment Drug: mannitol Drug: methacholine

MedlinePlus related topics: Asthma

Drug Information available for: Mannitol Methacholine Methacholine chloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	Mannitol Bronchoprovocation Challenge Ancillary Study Protocol to Best Adjustment Strategy for Asthma Over Long Term

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:

Mannitol bronchoprovocation challenge testing is safe, effective and well tolerated as compared to methacholine. [ Time Frame: At 6 weeks, 20 weeks, and 32 weeks. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To evaluate the applicability of mannitol bronchoprovocation to characterize the asthma phenotype. [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Estimated Enrollment:	320
Study Start Date:	December 2007
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator guideline based dose adjustment	Other: guideline based dose adjustment standard dose adjustment
2: Experimental mannitol	Drug: mannitol indirect mannitol challenge
3: Active Comparator methacholine challenge	Drug: methacholine methacholine challenge

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00585260

Contacts

Contact: Christine A Sorkness, Pharm.D.

608-263-2285

sorkness@wisc.edu

Locations

United States, Wisconsin
University of Wisconsin Madison Department of Asthma, Allergy and Pulmonary Clinical Research	Recruiting
Madison, Wisconsin, United States, 53792
Principal Investigator: Christine A Sorkness, Pharm.D.

Sponsors and Collaborators

University of Wisconsin, Madison

Pharmaxis

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Principal Investigator:	Christine A Sorkness, Pharm.D.	University of Wisconsin, Madison
Principal Investigator:	Christine A Sorkness, Pharm.D.	University of Wisconsin, Madison

More Information

Responsible Party:	University of Wisconsin - Madison ( Chrisitine A. Sorkness, Pharm.D. )
Study ID Numbers:	H-2007-0071, 144QK18
Study First Received:	December 26, 2007
Last Updated:	December 26, 2007
ClinicalTrials.gov Identifier:	NCT00585260
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Wisconsin, Madison:

asthma
bronchoprovocation challenge test
mannitol
methacholine

Study placed in the following topic categories:

Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Mannitol
Lung Diseases

Methacholine Chloride
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Parasympathomimetics
Respiratory System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Agonists
Bronchial Diseases
Immune System Diseases
Bronchoconstrictor Agents
Diuretics, Osmotic
Miotics

Diuretics
Physiological Effects of Drugs
Cardiovascular Agents
Cholinergic Agents
Pharmacologic Actions
Natriuretic Agents
Autonomic Agents
Therapeutic Uses
Muscarinic Agonists
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009