Effect of Fluticasone Furoate on Methacholine Challenge
NCT ID: NCT03898466
Last Updated: 2019-12-10
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
PHASE4
14 participants
INTERVENTIONAL
2018-10-30
2019-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Fluticasone Furoate
Daily inhalation of 100mcg fluticasone furoate for 7 days Response to methacholine induced bronchoconstriction will be assessed on Day 1 before first inhalation of study treatment (baseline) and again at 24, 72 and 168 hours.
The change in airway responsiveness to methacholine will be determined as a dose shift in methacholine PD20 from baseline to each of the three timepoints
Fluticasone furoate
Inhaled corticosteroid
Matching Placebo
Daily inhalation of inactive placebo comparator for 7 days Response to methacholine induced bronchoconstriction will be assessed on Day 1 before first inhalation of study treatment (baseline) and again at 24, 72 and 168 hours.
The change in airway responsiveness to methacholine will be determined as a dose shift in methacholine PD20 from baseline to each of the three timepoints
Matching placebo
Placebo inhaler
Interventions
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Fluticasone furoate
Inhaled corticosteroid
Matching placebo
Placebo inhaler
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* methacholine PD20 less than or equal to 400mcg
* no allergen exposure (if atopic) or respiratory infection for at least 4 weeks prior to study start
Exclusion Criteria
* poorly controlled asthma
* current smoker or ex smoker with greater than 10 pack year history
* pregnancy or breast-feeding
* health concern/condition that would preclude participation for safety reasons
18 Years
ALL
No
Sponsors
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University of Saskatchewan
OTHER
Responsible Party
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Don Cockcroft
Professor
Locations
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Asthma Research Lab University of Saskatchewan Room 346 Ellis Hall
Saskatoon, Saskatchewan, Canada
Countries
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References
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Okonkwo CS, Davis BE, Blais CM, Cockcroft DW. Short-term effect of once-daily fluticasone furoate on methacholine-induced bronchoconstriction in mild asthmatics. Respir Med. 2019 Sep;156:53-57. doi: 10.1016/j.rmed.2019.08.007. Epub 2019 Aug 13.
Other Identifiers
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Bio ID 366
Identifier Type: -
Identifier Source: org_study_id