Inhaled Allergen Challenge Methodology: Assessment of a Vibrating Mesh Nebulizer for Allergen Administration

NCT03491358 | Completed

• 1 other identifier: SOLO ALLERGEN 18
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 3

Brief Summary

This study will assess the Aerogen Solo® (Solo®) vibrating mesh nebulizer as a potential new device for use in allergen challenge testing.

Conditions

Asthma

Keywords

vibrating mesh nebulizer; allergen challenge

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Predicted allergen Solo EAR PD20

  Baseline (based on baseline methacholine challenge and skin test endpoint results)

Study Arms (2)

Wright jet nebulizer

ACTIVE COMPARATOR

Will employ the Wright jet nebulizer for use in an allergen challenge triad

Device: Wright jet nebulizer

Solo vibrating mesh nebulizer

EXPERIMENTAL

Will employ the Aerogen Solo vibrating mesh device for use in an allergen challenge triad

Device: Aerogen Solo

Interventions

Wright jet nebulizer DEVICE

Roxon Medi-Tech, Montreal, QC, Canada

Wright jet nebulizer

Aerogen Solo DEVICE

Aerogen Ltd., Galway, Ireland

Solo vibrating mesh nebulizer

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• pregnant or lactating

Sponsors & Collaborators

• University of Saskatchewan: lead

Study Sites (3)

McMaster University

Hamilton, Ontario, L8N 3Z5, Canada

Location

Laval University

Québec, Quebec, G1V 4G5, Canada

Location

Asthma Research Lab - University of Saskatchewan

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

Related Publications (1)

• 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.

  PMID: 31788006 DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Dr. Don Cockcroft, MD

  University of Saskatchewan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, College of Medicine

Study Record Dates

• First Submitted: March 29, 2018
• First Posted: April 9, 2018
• Study Start: November 27, 2018
• Primary Completion: July 24, 2019
• Study Completion: July 24, 2019
• Last Updated: December 10, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)