Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Mannitol Bronchoprovocation Challenge Ancillary Study/ACRN

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by University of Wisconsin, Madison.
Recruitment status was  Recruiting
Information provided by:
University of Wisconsin, Madison Identifier:
First received: December 26, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted

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

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

Resource links provided by NLM:

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
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


Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00585260

Contact: Christine A Sorkness, Pharm.D. 608-263-2285

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

No publications provided

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

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

Additional relevant MeSH terms:
Bronchial Diseases
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Methacholine Chloride
Autonomic Agents
Bronchoconstrictor Agents
Cardiovascular Agents
Cholinergic Agents
Cholinergic Agonists
Diuretics, Osmotic
Molecular Mechanisms of Pharmacological Action
Muscarinic Agonists
Natriuretic Agents
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses processed this record on November 20, 2014