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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02822859
• Other study ID #: MCH NEB-1
• Status: Completed
• Phase: N/A
• First received: June 30, 2016
• Last updated: October 24, 2017
• Start date: June 2016
• Est. completion date: September 2016

Study information

• Verified date: October 2017
• Source: University of Saskatchewan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Device:
• Wright nebulizer
Roxon Medi-Tech, Montreal, QC, Canada
• Bennett-Twin nebulizer
Puritan Bennett Corp., Carlsbad, CA, USA
• Aeroneb Solo
Aerogen Ltd., Galway, Ireland

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario
Canada	Laval University	Québec
Canada	Asthma Research Lab - University of Saskatchewan	Saskatoon	Saskatchewan

Sponsors (1)

Lead Sponsor	Collaborator
University of Saskatchewan

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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