An interventional study of Wright jet nebulizer and Aerogen Solo in Asthma, sponsored by McMaster University. Status unknown at 1 site in Canada. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2020-11-16.
Sponsored by McMaster University · Not applicable, Interventional, and Diagnostic
This is a mechanistic study. Having established safety with the Solo® nebulizer and the ability to predict allergen PD20 using the methacholine PD20 and STE, the current study will assess the use of the Solo® vibrating mesh nebulizer on development of allergen-induced endpoints during the late phase response.
Ten asthmatic subjects (>18 years, both sexes) who have stable asthma will be recruited to undergo inhaled allergen and diluent challenges for a randomized, 2-way crossover study. The primary objective is to compare the development of LAR between allergen (known to cause EAR and LAR) and diluent control challenges (does not cause EAR and LAR) using the Solo® vibrating mesh nebulizer using a standardized inhaled allergen challenge. Subject will undergo an allergen challenge with the Solo® compared to two different controls; diluent inhalation (a negative control with saline inhalation that does not cause LAR), and versus allergen challenge with control Wright nebulizer (positive control using a nebulizer that is known to cause LAR). Up to 2 academic centres will participate in this study. The results of this study will examine if the Solo® vibrating mesh nebulizer is an adequate substitution for the Wright nebulizer.
Screening
Skin Prick test and Skin Prick test endpoint
Randomization
The washout time after each allergen/diluent challenge triad will be 3-5 weeks.
Wright Nebulizer Allergen Inhalation triad will be conducted over 3 consecutive days.
On day 1: Wright® MCT to determine methacholine PC20 for 1) eligibility, and 2) to calculate the predicted Wright® allergen PC20. If the participant meets eligibility criterion, they will undergo blood draw, sputum induction and breath analysis to measure baseline airway inflammation. Day 2: Wright® allergen challenge will be performed. Participants that demonstrate early asthmatic response (≥20% drop in FEV1 during the period10 min-2h post-allergen) and the late asthmatic response (≥15% drop in FEV1 during the period 3-7h post-allergen challenge) will be eligible to continue in the study. If the participant meets eligibility criterion, they will undergo blood draw, sputum induction and breath analysis to measure airway inflammation at 7h post-challenge. Day 3:Wright® MCT to determine the degree of allergen-induced airway hyperresponsiveness, and they will undergo blood draw, sputum induction and breath analysis to measure airway inflammation at 24h post-challenge.
The order of the Solo® nebulizer allergen and diluent challenges will be conducted in a random order during the second and third triads. These challenge triads will be conducted over 3 consecutive days. Day 1: Solo® MCT to determine methacholine PD20 to calculate the predicted Solo® allergen PD20, followed by sputum induction to measure baseline airway inflammation. Day 2: Solo® allergen challenge or diluent challenge will be performed. Sputum induction will be conducted to measure airway inflammation at 7h post-challenge. Day 3: Solo® MCT to determine the degree of airway hyperresponsiveness at 24h post-allergen and post-diluent challenge, followed by sputum induction to measure airway inflammation at 24h post-challenge.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's planned enrollment of 10 is below the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →McMaster University is the lead sponsor of 720 studies on the registry; 124 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
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Exclusion Criteria:
Will employ the Wright jet nebulizer for use in an allergen challenge triad
Device: Wright jet nebulizer
Will employ the Aerogen Solo vibrating mesh device for use in an allergen challenge triad
Device: Aerogen Solo
Roxon Medi-Tech, Montreal, QC, Canada
Aerogen Ltd., Galway, Ireland
Development of LAR after Allergen Challenge
The primary objective is to compare the development of LAR between allergen (known to cause EAR and LAR) and diluent control challenges (does not cause EAR and LAR) using the Solo® vibrating mesh nebulizer using a standardized inhaled allergen challenge.
Time frame: Basline
Development of LAR between Allergen and Diluent
To compare the late asthmatic response (LAR) between inhaled allergen and inhaled diluent using the Solo® vibrating mesh nebulizer; and
Time frame: based on baseline methacholine challenge and skin test endpoint results
Magnitude of Airway Inflammation
To compare the magnitude of airway inflammation after inhaled allergen and inhaled diluent using the Solo® vibrating mesh nebulizer; and after inhaled allergen between the Solo® vibrating mesh nebulizer and the Wright® jet nebulizer
Time frame: based on baseline methacholine challenge and skin test endpoint results
Plan to share: No
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McMaster University