Mannitol Bronchoprovocation Challenge Ancillary Study/ACRN
NCT ID: NCT00585260
Last Updated: 2019-08-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
66 participants
INTERVENTIONAL
2007-12-31
2010-02-16
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Exploratory Mannitol
This is an exploratory / ancillary study open to all participants in the BASALT trial \[NCT00495157\] who consented to undergo mannitol bronchoprovocation procedures during the 36 week treatment period
mannitol
indirect mannitol challenge
Interventions
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mannitol
indirect mannitol challenge
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* requirement for more than two albuterol treatments for reversal of the methacholine bronchoprovocation challenge procedure at visit 4 in the BASALT parent trial
18 Years
80 Years
ALL
No
Sponsors
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Syntara
INDUSTRY
National Heart, Lung, and Blood Institute (NHLBI)
NIH
University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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Christine A Sorkness, Pharm.D.
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Locations
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University of Wisconsin Madison Department of Asthma, Allergy and Pulmonary Clinical Research
Madison, Wisconsin, United States
Countries
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References
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Calhoun WJ, Ameredes BT, King TS, Icitovic N, Bleecker ER, Castro M, Cherniack RM, Chinchilli VM, Craig T, Denlinger L, DiMango EA, Engle LL, Fahy JV, Grant JA, Israel E, Jarjour N, Kazani SD, Kraft M, Kunselman SJ, Lazarus SC, Lemanske RF, Lugogo N, Martin RJ, Meyers DA, Moore WC, Pascual R, Peters SP, Ramsdell J, Sorkness CA, Sutherland ER, Szefler SJ, Wasserman SI, Walter MJ, Wechsler ME, Boushey HA; Asthma Clinical Research Network of the National Heart, Lung, and Blood Institute. Comparison of physician-, biomarker-, and symptom-based strategies for adjustment of inhaled corticosteroid therapy in adults with asthma: the BASALT randomized controlled trial. JAMA. 2012 Sep 12;308(10):987-97. doi: 10.1001/2012.jama.10893.
Other Identifiers
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144QK18
Identifier Type: -
Identifier Source: secondary_id
H-2007-0071
Identifier Type: -
Identifier Source: org_study_id
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