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Reversibility of Methacholine Induced Bronchoconstriction

NCT ID: NCT05977699

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-12

Study Completion Date

2024-12-30

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.

Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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salbutamol delivered via pressurized metered dose inhaler

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

Group Type ACTIVE_COMPARATOR

salbutamol pressurized metered dose inhaler

Intervention Type DRUG

administration of 200microliters of salbutamol to reverse methacholine induced bronchoconstriction using a pressurized metered dose inhaler plus spacer

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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

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

salbutamol delivered with vibrating mesh nebulizer

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

Group Type EXPERIMENTAL

salbutamol aqueous solution

Intervention Type DRUG

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

Interventions

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salbutamol aqueous solution

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

Intervention Type DRUG

salbutamol pressurized metered dose inhaler

administration of 200microliters of salbutamol to reverse methacholine induced bronchoconstriction using a pressurized metered dose inhaler plus spacer

Intervention Type DRUG

placebo

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

Intervention Type OTHER

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Saskatchewan

OTHER

Sponsor Role lead

Responsible Party

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Don Cockcroft

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Don Cockcroft, MD

Role: PRINCIPAL_INVESTIGATOR

University of Saskatchewan

Locations

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Asthma Research Lab University of Saskatchewan Room 346 Ellis Hall

Saskatoon, Saskatchewan, Canada

Site Status

Countries

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Canada

Other Identifiers

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BIO 3632

Identifier Type: -

Identifier Source: org_study_id