Reversibility of Methacholine Induced Bronchoconstriction

April 27, 2026 updated by: Don Cockcroft, University of Saskatchewan

Salbutamol Reversal of Methacholine Induced Bronchoconstriction: Vibrating Mesh Nebulizer Versus Pressurized Metered Dose Inhaler

The study will compare salbutamol reversibility of methacholine induced bronchoconstriction between a pressurized metered dose inhaler with a spacer versus nebulizer administration using a vibrating mesh nebulizer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 0W8
        • Asthma Research Lab University of Saskatchewan Room 346 Ellis Hall

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • age (years) at least 18, male or female
  • no confounding health issue (i.e. no health conditions, other than asthma, that would put the participant at risk or affect data integrity)
  • baseline FEV1 ≥ 65% predicted (per Quanjer GLI 2012)
  • methacholine PD20 ≤ 800mcg

Exclusion Criteria:

  • respiratory infection within 4 weeks of Visit 1
  • exposure to triggers of respiratory symptoms within 4 weeks of Visit 1
  • currently pregnant or breastfeeding
  • current smoker (cigarettes, vaping)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: salbutamol delivered via pressurized metered dose inhaler
200mcg of salbutamol will be delivered using a pressurized metered dose inhaler plus spacer
Drug: salbutamol pressurized metered dose inhaler
administration of 200microliters of salbutamol to reverse methacholine induced bronchoconstriction using a pressurized metered dose inhaler plus spacer
Placebo Comparator: placebo
normal saline will be administered with a vibrating mesh nebulizer and 200mcg of placebo will be administered using a pressurized metered dose inhaler plus spacer
Other: placebo
matching placebo delivered via pressurized metered dose inhaler plus spacer or normal saline via vibrating mesh nebulizer
Experimental: salbutamol delivered with vibrating mesh nebulizer
200microliters of salbutamol will be administered using a vibrating mesh nebulizer
Drug: salbutamol aqueous solution
administration of 200microliters of salbutamol to reverse methacholine induced bronchoconstriction using a vibrating mesh nebulizer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lung function recovery
Time Frame: up to 60 minutes post salbutamol administration
Maximal recovery in FEV1 and FVC (absolute volume and percent)
up to 60 minutes post salbutamol administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to lung function recovery
Time Frame: 0-60 minutes
Area under the curve from start of salbutamol administration to time at which maximal recovery occurs
0-60 minutes
Heart rate
Time Frame: 0-60 minutes
change in pulse after salbutamol administration
0-60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Saskatchewan

Investigators

  • Principal Investigator: Don Cockcroft, MD, University of Saskatchewan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2024

Primary Completion (Actual)

November 25, 2024

Study Completion (Actual)

November 25, 2024

Study Registration Dates

First Submitted

June 19, 2023

First Submitted That Met QC Criteria

July 26, 2023

First Posted (Actual)

August 4, 2023

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIO 3632

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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