MedDataX Logo

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

NCT ID: NCT02822859

Last Updated: 2017-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2016-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Wright

Methacholine challenge performed using the Wright nebulizer

Group Type ACTIVE_COMPARATOR

Wright nebulizer

Intervention Type DEVICE

Roxon Medi-Tech, Montreal, QC, Canada

Bennett-Twin

Methacholine challenge performed using the Bennett-Twin nebulizer

Group Type ACTIVE_COMPARATOR

Bennett-Twin nebulizer

Intervention Type DEVICE

Puritan Bennett Corp., Carlsbad, CA, USA

Aeroneb Solo

Methacholine challenge performed using the Aeroneb Solo nebulizer

Group Type ACTIVE_COMPARATOR

Aeroneb Solo

Intervention Type DEVICE

Aerogen Ltd., Galway, Ireland

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Wright nebulizer

Roxon Medi-Tech, Montreal, QC, Canada

Intervention Type DEVICE

Bennett-Twin nebulizer

Puritan Bennett Corp., Carlsbad, CA, USA

Intervention Type DEVICE

Aeroneb Solo

Aerogen Ltd., Galway, Ireland

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Saskatchewan

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Don Cockcroft

MD, Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Don Cockcroft, MD

Role: PRINCIPAL_INVESTIGATOR

University of Saskatchewan

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

McMaster University

Hamilton, Ontario, Canada

Site Status

Asthma Research Lab - University of Saskatchewan

Saskatoon, Saskatchewan, Canada

Site Status

Laval University

Québec, , Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MCH NEB-1

Identifier Type: -

Identifier Source: org_study_id