Reversibility of Methacholine Induced Bronchoconstriction

University of Saskatchewan

Status and phase: Active, not recruiting; Phase 4

Conditions: Asthma

Treatments: Drug: salbutamol pressurized metered dose inhaler; Drug: salbutamol aqueous solution; Other: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05977699

BIO 3632

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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20 participants in 3 patient groups, including a placebo group

salbutamol delivered via pressurized metered dose inhaler

Active Comparator group

Description:

200mcg of salbutamol will be delivered using a pressurized metered dose inhaler plus spacer

Treatment:

Drug: salbutamol pressurized metered dose inhaler

placebo

Placebo Comparator group

Description:

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

Treatment:

Other: placebo

salbutamol delivered with vibrating mesh nebulizer

Experimental group

Description:

200microliters of salbutamol will be administered using a vibrating mesh nebulizer

Treatment:

Drug: salbutamol aqueous solution