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Completed

NCT Number: NCT05977699

Reversibility of Methacholine Induced Bronchoconstriction

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Asthma Research Lab University of Saskatchewan Room 346 Ellis Hall

Saskatoon, Saskatchewan, S7N 0W8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

salbutamol aqueous solution

Drug

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

salbutamol pressurized metered dose inhaler

Drug

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

Placebo

Other

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

Primary outcomes

  1. Lung function recovery

    Time frame: up to 60 minutes post salbutamol administration

    Maximal recovery in FEV1 and FVC (absolute volume and percent)

Secondary outcomes

  1. Time to lung function recovery

    Time frame: 0-60 minutes

    Area under the curve from start of salbutamol administration to time at which maximal recovery occurs

  2. Heart rate

    Time frame: 0-60 minutes

    change in pulse after salbutamol administration

Sponsors and collaborators

Lead sponsor

University of Saskatchewan

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 4, 2023
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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