A Comparison of Three Nebulizers for Standard Clinical and Research Use in Methacholine Challenge Testing

NCT02822859 | Completed

• 1 other identifier: MCH NEB-1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief Summary

The study will assess three different nebulizers for use in methacholine challenge testing in order to determine if the Aeroneb Solo would make a suitable replacement for the long-used and now obsolete Wright and Bennett-Twin nebulizers. Results from each device will be compared to evaluate whether current guidelines for the methacholine challenge should be updated for superior standardization.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• airway responsiveness to methacholine (methacholine pd20)

  methacholine pd20 data will be compared between nebulizers (Wright, Bennett and Solo). Methacholine PD20 data generated with the Wright nebulizer will serve as the comparator for the methacholine pd20 generated with the Bennett and the Solo nebulizers.

  Two weeks

Study Arms (3)

Wright

ACTIVE COMPARATOR

Methacholine challenge performed using the Wright nebulizer

Device: Wright nebulizer

Bennett-Twin

ACTIVE COMPARATOR

Methacholine challenge performed using the Bennett-Twin nebulizer

Device: Bennett-Twin nebulizer

Aeroneb Solo

ACTIVE COMPARATOR

Methacholine challenge performed using the Aeroneb Solo nebulizer

Device: Aeroneb Solo

Interventions

Wright nebulizer DEVICE

Roxon Medi-Tech, Montreal, QC, Canada

Wright

Bennett-Twin nebulizer DEVICE

Puritan Bennett Corp., Carlsbad, CA, USA

Bennett-Twin

Aeroneb Solo DEVICE

Aerogen Ltd., Galway, Ireland

Aeroneb Solo

Eligibility Criteria

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

You may qualify if:

• Men and women aged 18 or older
• Stable asthma
• Baseline methacholine PC20 less than or equal to 16mg/mL
• Baseline lung function greater than 65% predicted

You may not qualify if:

• Use of long-acting bronchodilators within 30 days of Visit 1
• Pregnant or nursing
• Cardiovascular problems
• Respiratory illness within 4 weeks of Visit 1
• Allergen-induced asthma exacerbation within 4 weeks of Visit 1

Sponsors & Collaborators

• University of Saskatchewan: lead

Study Sites (3)

McMaster University

Hamilton, Ontario, L8N 3Z5, Canada

Location

Asthma Research Lab - University of Saskatchewan

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

Laval University

Québec, G1V 4G5, 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

• Don Cockcroft, MD

  University of Saskatchewan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Professor

Study Record Dates

• First Submitted: June 30, 2016
• First Posted: July 4, 2016
• Study Start: June 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 26, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will share

Locations

CA (3)