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Completed

NCT Number: NCT02822859

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McMaster University, Hamilton, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Wright nebulizer

Device

Roxon Medi-Tech, Montreal, QC, Canada

Bennett-Twin nebulizer

Device

Puritan Bennett Corp., Carlsbad, CA, USA

Aeroneb Solo

Device

Aerogen Ltd., Galway, Ireland

Primary outcomes

  1. airway responsiveness to methacholine (methacholine pd20)

    Time frame: Two weeks

    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.

Sponsors and collaborators

Lead sponsor

University of Saskatchewan

Other

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jul 4, 2016
Registry last updated
Oct 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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