Reversibility of Methacholine Induced Bronchoconstriction

Phase 4

Active, not recruiting

• Conditions: Asthma
• Interventions: Drug: salbutamol pressurized metered dose inhaler; Drug: salbutamol aqueous solution; Other: placebo

• Registration Number: NCT05977699
• Lead Sponsor: University of Saskatchewan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-19
• Study First Submitted QC: 2023-07-26
• Study First Posted: 2023-08-04
• Study Start: 2024-01-12
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-06
• Primary Completion: 2024-12-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
salbutamol delivered via pressurized metered dose inhaler	salbutamol pressurized metered dose inhaler	200mcg of salbutamol will be delivered using a pressurized metered dose inhaler plus spacer
salbutamol delivered with vibrating mesh nebulizer	salbutamol aqueous solution	200microliters of salbutamol will be administered using a vibrating mesh nebulizer
placebo	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Asthma Research Lab University of Saskatchewan Room 346 Ellis Hall; 🇨🇦 Saskatoon, Saskatchewan, Canada