Asthma Clinical Trial
Official title:
Inhaled Allergen Challenge Methodology: Assessment of a Vibrating Mesh Nebulizer for Allergen Administration
This study will assess the Aerogen Solo® (Solo®) vibrating mesh nebulizer as a potential new device for use in allergen challenge testing.
This will be a multi-center, randomized, cross-over study utilizing the expertise of three
Canadian academic centers (University of Saskatchewan, McMaster University, Laval University)
that have been performing allergen inhalation challenges and other bronchoprovocation studies
for more than forty years.
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.
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