Assessment of SOLO Vibrating Mesh Nebulizer for Allergen-Induced Late Asthmatic Responses

NCT04630405 | Unknown

• 1 other identifier: McMaster-SOLO-LAR
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• 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.

  Basline

Secondary Outcomes (2)

• Development of LAR between Allergen and Diluent

  based on baseline methacholine challenge and skin test endpoint results

• Magnitude of Airway Inflammation

  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

ACTIVE COMPARATOR

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 - 100 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
• development of allergen-induced early and late asthmatic responses

You may not qualify if:

• pregnant or lactating

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

McMaster Cardio-Respiratory Research Lab

Hamilton, Ontario, L8N 3Z5, Canada

Location

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

• Gail Gauvreau, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gail Gauvreau, PhD

CONTACT

905 525-9140; gauvreau@mcmaster.ca

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

Study Record Dates

• First Submitted: November 10, 2020
• First Posted: November 16, 2020
• Study Start: January 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: November 16, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)