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NCT05977699 Clinical Trial

Reversibility of Methacholine Induced Bronchoconstriction

Asthma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05977699
Other study ID # BIO 3632
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date January 12, 2024
Est. completion date September 30, 2024

Study information
Verified date May 2024
Source University of Saskatchewan
Contact Beth Davis, PhD
Phone 306-844-1444
Email Beth.davis@usask.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date September 30, 2024
Est. primary completion date September 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• salbutamol aqueous solution
administration of 200microliters of salbutamol to reverse methacholine induced bronchoconstriction using a vibrating mesh nebulizer
• salbutamol pressurized metered dose inhaler
administration of 200microliters of salbutamol to reverse methacholine induced bronchoconstriction 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

Locations
Country Name City State
Canada Asthma Research Lab University of Saskatchewan Room 346 Ellis Hall Saskatoon Saskatchewan

Sponsors (1)
Lead Sponsor Collaborator
University of Saskatchewan

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Lung function recovery Maximal recovery in FEV1 and FVC (absolute volume and percent) up to 60 minutes post salbutamol administration
Secondary Time to lung function recovery Area under the curve from start of salbutamol administration to time at which maximal recovery occurs 0-60 minutes
Secondary Heart rate change in pulse after salbutamol administration 0-60 minutes
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