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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Device: Wright jet nebulizer; Device: Aerogen Solo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N 3Z5
      • McMaster University
  • Quebec
    • Québec City, Quebec, Canada, G1V 4G5
      • Laval University
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 0W8
      • Asthma Research Lab - University of Saskatchewan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• baseline FEV1 greater than or equal to 70%
• 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:

• pregnant or lactating

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Wright jet nebulizer; Will employ the Wright jet nebulizer for use in an allergen challenge triad	Device: Wright jet nebulizer; Roxon Medi-Tech, Montreal, QC, Canada
EXPERIMENTAL: Solo vibrating mesh nebulizer; Will employ the Aerogen Solo vibrating mesh device for use in an allergen challenge triad	Device: Aerogen Solo; Aerogen Ltd., Galway, Ireland

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: University of Saskatchewan

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 27, 2018
• Primary Completion (ACTUAL): July 24, 2019
• Study Completion (ACTUAL): July 24, 2019

Study Registration Dates

• First Submitted: March 29, 2018
• First Submitted That Met QC Criteria: April 5, 2018
• First Posted (ACTUAL): April 9, 2018

Study Record Updates

• Last Update Posted (ACTUAL): December 10, 2019
• Last Update Submitted That Met QC Criteria: December 9, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: allergen challenge; vibrating mesh nebulizer
• Other Study ID Numbers: SOLO ALLERGEN 18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No