Reversibility of Methacholine Induced Bronchoconstriction

Sponsor

University of Saskatchewan (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05977699

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Asthma	Drug: salbutamol aqueous solution Drug: salbutamol pressurized metered dose inhaler Other: placebo	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Sep 30, 2024

Anticipated Study Completion Date :

Sep 30, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Asthma Research Lab University of Saskatchewan Room 346 Ellis Hall	Saskatoon	Saskatchewan	Canada	S7N 0W8

Sponsors and Collaborators

University of Saskatchewan

Investigators

Principal Investigator: Don Cockcroft, MD, University of Saskatchewan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Don Cockcroft, Professor, University of Saskatchewan

ClinicalTrials.gov Identifier:

NCT05977699

Other Study ID Numbers:

BIO 3632

First Posted:

Aug 4, 2023

Last Update Posted:

Aug 4, 2023

Last Verified:

Jul 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Albuterol

Study Results

No Results Posted as of Aug 4, 2023