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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wright jet nebulizer | Active Comparator | Will employ the Wright jet nebulizer for use in an allergen challenge triad |
|
| Solo vibrating mesh nebulizer | Experimental | Will employ the Aerogen Solo vibrating mesh device for use in an allergen challenge triad |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wright jet nebulizer | Device | Roxon Medi-Tech, Montreal, QC, Canada |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Allergen Solo EAR PD20 (provocative dose causing a 20% fall in forced expiratory volume, FEV1) | Record the dose of allergen required to induce a 20% fall in forced expiratory volume using the Solo device | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Predicted allergen Solo EAR PD20 | Will be predicted using the standard equation that employs the STE and MCT results | Baseline (based on baseline methacholine challenge and skin test endpoint results) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Don Cockcroft, MD | University of Saskatchewan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McMaster University | Hamilton | Ontario | L8N 3Z5 | Canada | ||
| Laval University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31788006 | Derived | 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. |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Aerogen Solo |
| Device |
Aerogen Ltd., Galway, Ireland |
|
| Québec |
| Quebec |
| G1V 4G5 |
| Canada |
| Asthma Research Lab - University of Saskatchewan | Saskatoon | Saskatchewan | S7N 0W8 | Canada |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |