Clinical trial NCT02822859: A Comparison of Three Nebulizers for Standard Clinical and Research Use in Methacholine Challenge Testing
Official title: A Comparison of Three Nebulizers for Standard Clinical and Research Use in Methacholine Challenge Testing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
First posted: 2016-07-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: airway responsiveness to methacholine (methacholine pd20)
timeFrame: Two weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
city: Saskatoon
country: Canada
facility: Asthma Research Lab - University of Saskatchewan
state: Saskatchewan
city: Québec
country: Canada
facility: Laval University
Study officials:
affiliation: University of Saskatchewan
name: Don Cockcroft, MD
role: PRINCIPAL_INVESTIGATOR
References: