Reversibility of Methacholine Induced Bronchoconstriction

NCT05977699 | Completed Phase 4

• 1 other identifier: BIO 3632
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Lung function recovery

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

  up to 60 minutes post salbutamol administration

Secondary Outcomes (2)

• Time to lung function recovery

  0-60 minutes

• Heart rate

  0-60 minutes

Study Arms (3)

salbutamol delivered via pressurized metered dose inhaler

ACTIVE COMPARATOR

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

Drug: salbutamol pressurized metered dose inhaler

placebo

PLACEBO COMPARATOR

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

salbutamol delivered with vibrating mesh nebulizer

EXPERIMENTAL

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

Drug: salbutamol aqueous solution

Interventions

salbutamol aqueous solution DRUG

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

salbutamol delivered with 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

salbutamol delivered via pressurized metered dose inhaler

placebo OTHER

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

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Saskatchewan: lead

Study Sites (1)

Asthma Research Lab University of Saskatchewan Room 346 Ellis Hall

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

• Don Cockcroft, MD

  University of Saskatchewan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 19, 2023
• First Posted: August 4, 2023
• Study Start: January 12, 2024
• Primary Completion: November 25, 2024
• Study Completion: November 25, 2024
• Last Updated: May 4, 2026

Record last verified: 2024-12

Locations

CA (1)