Investigation of Novel Procedure for Methacholine Challenge Testing

NCT02965482 | Completed

• 1 other identifier: MCT-SOLOWRIGHT-13
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The study will compare a novel volumetric method (performed with the Aerogen Solo vibrating mesh nebulizer) with the standard two-minute tidal breathing protocol (performed with the Wright jet nebulizer) for methacholine challenge testing. The results will then give an indication as to whether the novel technique accurately assesses a given dose of methacholine with the new Aerogen Solo device. In addition, the reproducibility of test results with each method will be examined. Altogether, the findings from this investigation may provide means for better standardization of current testing guidelines.

Conditions

Asthma

Keywords

methacholine, airway hyperresponsiveness

Outcome Measures

Primary Outcomes (1)

• Methacholine PD20 values of two nebulizers, each with a different testing protocol

  Do the nebulizers produce similar responses at the same dose

  2 weeks

Secondary Outcomes (1)

• Comparability of PD20 values with a single nebulizer over two methacholine challenges

  2 weeks

Study Arms (2)

Aerogen Solo

ACTIVE COMPARATOR

Volumetric method of methacholine challenge testing performed using the Aerogen Solo nebulizer

Device: Aerogen Solo Nebulizer

Wright

ACTIVE COMPARATOR

Two-minute tidal breathing method of methacholine challenge testing performed using the Wright nebulizer

Device: Wright Nebulizer

Interventions

Wright Nebulizer DEVICE

Roxon Medi-Tech, Montreal, QC, Canada

Wright

Aerogen Solo Nebulizer DEVICE

Aerogen Ltd., Galway, Ireland

Aerogen Solo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged 18 or older
• Stable asthma
• Baseline methacholine PC20 less than or equal to 16mg/mL
• Baseline lung function equal or greater than 65% of predicted FEV1

You may not qualify if:

• Use of long-acting bronchodilators within 7 days of visit 1
• Pregnant or nursing women
• Cardiovascular problems
• Upper respiratory tract infection within 4 weeks of visit 1
• Allergy-induced asthma exacerbation within 4 weeks of visit 1

Sponsors & Collaborators

• University of Saskatchewan: lead

Study Sites (1)

Asthma Research Lab - University of Saskatchewan

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

MeSH Terms

Conditions

Asthma; Respiratory Hypersensitivity

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Don Cockcroft, MD

  University of Saskatchewan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Professor

Study Record Dates

• First Submitted: November 14, 2016
• First Posted: November 16, 2016
• Study Start: November 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: June 14, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)