The Effect of Deep Inhalation on Mannitol Responsiveness
NCT ID: NCT03505489
Last Updated: 2019-05-15
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
PHASE3
26 participants
INTERVENTIONAL
2018-06-01
2019-04-30
Brief Summary
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Detailed Description
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This is a single center, open label, randomized study. Individuals with stable asthma will be eligible for enrollment. The study will consist of two parts, screening and testing.
Part 1: Screening
Participants will undergo consent procedures and assessments of fractional exhaled nitric oxide levels, airway responsiveness to methacholine and sputum induction. If participants show airway responsiveness to methacholine (i.e. methacholine PC20 16mg/mL), they will be scheduled to undergo the testing part of the study.
Part 2: Testing
Participants will be randomized to undergo two methacholine or two mannitol challenges. Further randomization will occur with respect to whether the standard challenge method or the modified challenge method is performed first.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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Mannitol challenge
Mannitol challenge performed per standard mannitol challenge procedure with deep inhalation technique
Deep inhalation technique
Use of deep inhalations for administration of inhalant
Mannitol
Mannitol indirect bronchoconstrictor used for bronchoprovocation challenge
Mannitol challenge w/ TBI
Mannitol challenge performed per standard mannitol challenge procedure except with tidal breathing technique
Tidal breathing technique
Use of tidal breathing for administration of inhalant
Mannitol
Mannitol indirect bronchoconstrictor used for bronchoprovocation challenge
Methacholine challenge w/ DI
Methacholine challenge performed per standard 2-minute tidal breathing challenge procedure except with deep inhalation technique
Deep inhalation technique
Use of deep inhalations for administration of inhalant
Methacholine
Methacholine direct bronchoconstrictor used for bronchoprovocation challenge
Methacholine challenge
Methacholine challenge performed per standard 2-minute tidal breathing challenge procedure (tidal breathing technique)
Tidal breathing technique
Use of tidal breathing for administration of inhalant
Methacholine
Methacholine direct bronchoconstrictor used for bronchoprovocation challenge
Interventions
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Deep inhalation technique
Use of deep inhalations for administration of inhalant
Tidal breathing technique
Use of tidal breathing for administration of inhalant
Methacholine
Methacholine direct bronchoconstrictor used for bronchoprovocation challenge
Mannitol
Mannitol indirect bronchoconstrictor used for bronchoprovocation challenge
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* men and women between 18 and 75 years of age
* FEV1 at first measurement of greater than or equal to 65% predicted
* methacholine provocative concentration causing a 20% in FEV1 at screening that is less than or equal to 16mg/ml
* generally good health
* stable asthma
Exclusion Criteria
* worsening of asthma within 4 weeks of screening visit
* lung disease other than asthma
* significant medical comorbidity
* current smoker or ex-smoker with significant smoking history
* currently pregnant or breastfeeding
18 Years
75 Years
ALL
No
Sponsors
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University of Saskatchewan
OTHER
Responsible Party
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Don Cockcroft
Professor, College of Medicine
Principal Investigators
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Dr. Don Cockcroft, MD
Role: PRINCIPAL_INVESTIGATOR
University of Saskatchewan
Locations
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Asthma Research Lab - University of Saskatchewan
Saskatoon, Saskatchewan, Canada
Countries
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References
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Blais CM, Davis BE, Cockcroft DW. The effect of deep inhalation on mannitol responsiveness. Clin Exp Allergy. 2020 Mar;50(3):308-314. doi: 10.1111/cea.13543. Epub 2019 Dec 14.
Blais CM, Davis BE, Graham BL, Cockcroft DW. Respiratory Duty Cycles in Individuals With and Without Airway Hyperresponsiveness. Chest. 2020 Feb;157(2):356-362. doi: 10.1016/j.chest.2019.09.005. Epub 2019 Sep 19.
Other Identifiers
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MAN-2018
Identifier Type: -
Identifier Source: org_study_id
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