Inhaled Allergen Challenge Methodology: Assessment of a Vibrating Mesh Nebulizer for Allergen Administration
NCT ID: NCT03491358
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
NA
18 participants
INTERVENTIONAL
2018-11-27
2019-07-24
Brief Summary
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Detailed Description
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Each participant will be required to attend the research lab on five occasions (Visits 1-5). At Visit 1, study staff will provide an overview of the study purpose and procedure and answer any questions the participant may have. The individual will then provide consent if they wish to participate (i.e. sign the consent form). Skin prick testing to determine relevant allergen sensitivities and to determine which allergen extract will be used for the skin test endpoint (STE) and allergen inhalation challenge will then be performed. The participant will be randomized with respect to which nebulizer (Solo® or Wright) will be used first. The choice of nebulizer for the first participant will be via blinded draw. Subsequent nebulizer assignments will alternate. Participants will undergo the STE procedure and methacholine challenge testing (MCT) at visit 2; an allergen challenge will be done the next day at Visit 3 using the same nebulizer as was used for the MCT at Visit 2. Visits 4 and 5 will also be performed on consecutive days and will involve methacholine and allergen challenge testing, respectively, using the nebulizer that was not used at Visits 2 and 3. A minimum of two weeks must separate Visits 3 and 4.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
DIAGNOSTIC
NONE
Study Groups
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Wright jet nebulizer
Will employ the Wright jet nebulizer for use in an allergen challenge triad
Wright jet nebulizer
Roxon Medi-Tech, Montreal, QC, Canada
Solo vibrating mesh nebulizer
Will employ the Aerogen Solo vibrating mesh device for use in an allergen challenge triad
Aerogen Solo
Aerogen Ltd., Galway, Ireland
Interventions
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Wright jet nebulizer
Roxon Medi-Tech, Montreal, QC, Canada
Aerogen Solo
Aerogen Ltd., Galway, Ireland
Eligibility Criteria
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Inclusion Criteria
* positive response to inhaled methacholine (i.e. PD20 less than 400mcg)
* evidence of atopy (i.e. positive skin prick test to an allergen that can be used for the inhalation challenge
* absence of respiratory infection for at least 4 weeks
* absence of allergen exposure (or other trigger of upper or lower respiratory symptoms) for at least 4 weeks
* current nonsmoker (ex-smoker allowed; case by case basis; investigator discretion)
* require only infrequent short-acting beta2 agonist (i.e. salbutamol or terbutaline) to treat/control asthma (i.e. no inhaled corticosteroid or combination therapies, no intranasal corticosteroid; anti-histamines etc.)
* general good health with no other medical condition, medication use or lifestyle activities that would influence the outcome of the allergen challenge
Exclusion Criteria
18 Years
80 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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McMaster University
Hamilton, Ontario, Canada
Laval University
Québec, Quebec, Canada
Asthma Research Lab - University of Saskatchewan
Saskatoon, Saskatchewan, Canada
Countries
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References
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Cockcroft DW, Davis BE, Blais CM, Boulet LP, Boulay ME, Villeneuve H, Gauvreau GM, O'Byrne PM, Howie KJ, Obminski CD. Use of a vibrating mesh nebulizer for allergen challenge. Allergy Asthma Clin Immunol. 2019 Nov 26;15:73. doi: 10.1186/s13223-019-0392-8. eCollection 2019.
Other Identifiers
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SOLO ALLERGEN 18
Identifier Type: -
Identifier Source: org_study_id