Clinical trial

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

Name

BIO 3632

Description

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.

Trial arms

Trial start

2024-01-12

Estimated PCD

2024-09-30

Trial end

2024-09-30

Status

Recruiting

Phase

Early phase I

Treatment

salbutamol aqueous solution

administration of 200microliters of salbutamol to reverse methacholine induced bronchoconstriction using a vibrating mesh nebulizer

Arms:

salbutamol delivered with 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

Arms:

salbutamol delivered via pressurized metered dose inhaler

placebo

matching placebo delivered via pressurized metered dose inhaler plus spacer or normal saline via vibrating mesh nebulizer

Arms:

placebo

Size

Primary endpoint

Lung function recovery

up to 60 minutes post salbutamol administration

Eligibility criteria

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)

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 20, 'type': 'ESTIMATED'}}

Updated at

2024-05-08

1 organization

1 product

1 indication

Organization

University of Saskatchewan

Product

Salbutamol

Indication

Asthma