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
Recruitment status was Recruiting
Sponsor:
University of Wisconsin, Madison
Collaborators:
Pharmaxis
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00585260
First received: December 26, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted
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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 |
| 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
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 |
| 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
Investigators
| 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 |
| ClinicalTrials.gov 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:
|
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 |
Pharmacologic Actions Cardiovascular Agents Therapeutic Uses 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 May 19, 2013