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

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Device: Wright nebulizer; Device: Bennett-Twin nebulizer; Device: Aeroneb Solo

Detailed Description

Sixty asthmatics (20 at each testing site: University of Saskatchewan, McMaster University, Laval University) will be recruited to undergo this randomized, triple cross-over study. Three nebulizers will be tested, the Wright, the Bennett-Twin and the new Aeroneb Solo.

Breakdown of study procedure: Participants will undergo three (potentially four) methacholine challenges, one with each nebulizer in randomized order. An additional methacholine challenge may be performed for screening purposes if the participant has not undergone methacholine challenge testing in one of the participating labs in the previous 6 months. The screening challenge will be performed with the standard nebulizer used at the given testing site (i.e. the Wright or the Bennett-Twin).

The methacholine challenges performed with the Wright and Bennett-Twin nebulizers will follow the two-minute tidal breathing protocol as outlined in the 1999 American Thoracic Society Guidelines for Methacholine Challenge Testing. The testing protocol used with the Aeroneb solo will be identical save for a 1 min inhalation period instead of 2 min. Each challenge will be stopped when a participant's forced expiratory volume in 1 second (FEV1) drops at least 20%. This will allow for the determination of the participant's PC20 (provocative concentration of methacholine causing a 20% fall in FEV1), which will subsequently be converted to a PD20 (provocative dose) value. A minimum 24-hour washout period between challenges will be enforced.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Wright; Methacholine challenge performed using the Wright nebulizer	Device: Wright nebulizer; Roxon Medi-Tech, Montreal, QC, Canada
Active Comparator: Bennett-Twin; Methacholine challenge performed using the Bennett-Twin nebulizer	Device: Bennett-Twin nebulizer; Puritan Bennett Corp., Carlsbad, CA, USA
Active Comparator: Aeroneb Solo; Methacholine challenge performed using the Aeroneb Solo nebulizer	Device: Aeroneb Solo; Aerogen Ltd., Galway, Ireland

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Saskatchewan

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: June 30, 2016
• First Submitted That Met QC Criteria: June 30, 2016
• First Posted (Estimate): July 4, 2016

Study Record Updates

• Last Update Posted (Actual): October 26, 2017
• Last Update Submitted That Met QC Criteria: October 24, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: MCH NEB-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Journal Publication