Reversibility of Methacholine Induced Bronchoconstriction

Study Overview
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Brief Summary
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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.

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

Conditions
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Asthma

Intervention / Treatment
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* Drug: salbutamol aqueous solution
* Drug: salbutamol pressurized metered dose inhaler
* Other: placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: salbutamol delivered via pressurized metered dose inhaler<br>200mcg of salbutamol will be delivered using a pressurized metered dose inhaler plus spacer | Drug: salbutamol pressurized metered dose inhaler<br>* administration of 200microliters of salbutamol to reverse methacholine induced bronchoconstriction using a pressurized metered dose inhaler plus spacer<br>|
| Placebo Comparator: placebo<br>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<br>* matching placebo delivered via pressurized metered dose inhaler plus spacer or normal saline via vibrating mesh nebulizer<br>|
| Experimental: salbutamol delivered with vibrating mesh nebulizer<br>200microliters of salbutamol will be administered using a vibrating mesh nebulizer | Drug: salbutamol aqueous solution<br>* administration of 200microliters of salbutamol to reverse methacholine induced bronchoconstriction using a vibrating mesh nebulizer<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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