Mannitol Bronchoprovocation Challenge Ancillary Study/ACRN

This study has been completed.
Sponsor:
Collaborators:
Pharmaxis
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00585260
First received: December 26, 2007
Last updated: October 6, 2015
Last verified: October 2015
  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

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
Study Completion Date: January 2011
Arms Assigned Interventions
Active Comparator: 1
guideline based dose adjustment
Other: guideline based dose adjustment
standard dose adjustment
Experimental: 2
mannitol
Drug: mannitol
indirect mannitol challenge
Active Comparator: 3
methacholine challenge
Drug: methacholine
methacholine challenge

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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
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 ClinicalTrials.gov identifier: NCT00585260

Locations
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
Pharmaxis
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Christine A Sorkness, Pharm.D. University of Wisconsin, Madison
  More Information

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00585260     History of Changes
Other Study ID Numbers: H-2007-0071  144QK18 
Study First Received: December 26, 2007
Last Updated: October 6, 2015
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on August 25, 2016