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CompletedNCT05977699Updated May 4, 2026

Reversibility of Methacholine Induced Bronchoconstriction

A Phase 4 interventional study of salbutamol aqueous solution and salbutamol pressurized metered dose inhaler in Asthma, sponsored by University of Saskatchewan. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-04.

Sponsored by University of Saskatchewan · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Asthma

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03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's enrollment of 16 is below the median of 83 across 2,752 interventional studies indexed under Asthma.

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Lead sponsor

University of Saskatchewan is the lead sponsor of 237 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
16 participants (actual)

Study arms

  • 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

  • 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

  • Experimental
    salbutamol delivered with vibrating mesh nebulizer

    200microliters of salbutamol will be administered using a vibrating mesh nebulizer

    Drug: salbutamol aqueous solution

Interventions

  • Drugsalbutamol aqueous solution

    administration of 200microliters of salbutamol to reverse methacholine induced bronchoconstriction using a vibrating mesh nebulizer

  • Drugsalbutamol pressurized metered dose inhaler

    administration of 200microliters of salbutamol to reverse methacholine induced bronchoconstriction using a pressurized metered dose inhaler plus spacer

  • Otherplacebo

    matching placebo delivered via pressurized metered dose inhaler plus spacer or normal saline via vibrating mesh nebulizer

06

What researchers measure

Primary outcomes

  1. Lung function recovery

    Maximal recovery in FEV1 and FVC (absolute volume and percent)

    Time frame: up to 60 minutes post salbutamol administration

Secondary outcomes

  1. Time to lung function recovery

    Area under the curve from start of salbutamol administration to time at which maximal recovery occurs

    Time frame: 0-60 minutes

  2. Heart rate

    change in pulse after salbutamol administration

    Time frame: 0-60 minutes

07

Study locations

1 site
  • Asthma Research Lab University of Saskatchewan Room 346 Ellis Hall
    Saskatoon, Saskatchewan S7N 0W8, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05977699
Lead sponsor
University of Saskatchewan
Responsible party
Don Cockcroft (Professor, University of Saskatchewan) — Principal investigator
First posted
Aug 4, 2023
Start date
Jan 12, 2024
Primary completion
Nov 25, 2024
Completion
Nov 25, 2024
Last update
May 4, 2026

Study contacts

Don Cockcroft, MD
principal investigator · University of Saskatchewan

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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