Back to resultsMannitol Bronchoprovocation Challenge Ancillary Study/ACRN
Primary Purpose
Asthma
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
mannitol
Sponsored by
About this trial
This is an interventional diagnostic trial for Asthma focused on measuring asthma, bronchoprovocation challenge test, mannitol, methacholine
Eligibility 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
Sites / Locations
- University of Wisconsin Madison Department of Asthma, Allergy and Pulmonary Clinical Research
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Exploratory Mannitol
Arm Description
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
Outcomes
Primary Outcome Measures
Incidence of Adverse Events
Mannitol bronchoprovocation challenge testing is safe, effective and well tolerated as compared to methacholine (conducted as part of the main BASALT trial).
Secondary Outcome Measures
Full Information
NCT ID
NCT00585260
First Posted
December 26, 2007
Last Updated
August 14, 2019
Sponsor
University of Wisconsin, Madison
Collaborators
Pharmaxis, National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00585260
Brief Title
Mannitol Bronchoprovocation Challenge Ancillary Study/ACRN
Official Title
Mannitol Bronchoprovocation Challenge Ancillary Study Protocol to Best Adjustment Strategy for Asthma Over Long Term
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
February 16, 2010 (Actual)
Study Completion Date
February 16, 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
Pharmaxis, National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is an ancillary study conducted as part of the BASALT trial [NCT00495157].
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
asthma, bronchoprovocation challenge test, mannitol, methacholine
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exploratory Mannitol
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
mannitol
Intervention Description
indirect mannitol challenge
Primary Outcome Measure Information:
Title
Incidence of Adverse Events
Description
Mannitol bronchoprovocation challenge testing is safe, effective and well tolerated as compared to methacholine (conducted as part of the main BASALT trial).
Time Frame
At 6 weeks, 20 weeks, and 32 weeks
Other Pre-specified Outcome Measures:
Title
Correlation of the baseline PD15FEV1 with other baseline physiologic measurements collected in the BASALT trial
Description
To evaluate the applicability of mannitol bronchoprovocation to characterize the asthma phenotype. Correlation of the baseline PD15FEV1 with other baseline physiologic measurements and methacholine bronchoprovocation performance as collected in the BASALT trial.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine A Sorkness, Pharm.D.
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin Madison Department of Asthma, Allergy and Pulmonary Clinical Research
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22968888
Citation
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.
Results Reference
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Mannitol Bronchoprovocation Challenge Ancillary Study/ACRN
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