Reversibility of Methacholine Induced Bronchoconstriction

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05977699

Enrollment

Registered

2023-08-04

Start date

2024-01-12

Completion date

2024-11-25

Last updated

2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Brief 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.

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

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

Secondary

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

Countries

Canada

Contacts

PRINCIPAL_INVESTIGATORDon Cockcroft, MD

University of Saskatchewan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 5, 2026