Regular Use Effect of Inhaled Ipratropium Bromide on Airway Responsiveness to Methacholine in Well-controlled Asthma

Overview

Study is looking at the development of tolerance to methacholine following regular use of ipratropium bromide in mild asthmatics.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 13, 2020

Detailed Description

This study is being conducted people with well controlled (mild) asthma to determine if ipratropium bromide taken three times daily for six days (i.e. 2 puffs in the morning, 2 puffs in the afternoon and 2 puffs in the evening) followed by a final dose on the morning of day 7 reduces the effectiveness of this medication on blocking the effect of methacholine challenge.

Interventions

  • Drug: Ipratropium Metered Dose Inhaler
    • MDI to deliver 20mcg per puff ipratropium bromide
  • Drug: placebo metered dose inhaler
    • matched MDI to deliver inactive drug

Arms, Groups and Cohorts

  • Active Comparator: Ipratropium bromide
    • 20mcg bronchodilator inhaler
  • Placebo Comparator: placebo
    • matching bronchodilator inhaler

Clinical Trial Outcome Measures

Primary Measures

  • Methacholine PD20
    • Time Frame: Pre treatment
    • dose of methacholine required to induce a 20% fall in FEV1 (volume of air forcefully exhaled in one second)
  • Methacholine PD20
    • Time Frame: Day 7 after starting treatment
    • dose of methacholine required to induce a 20% fall in FEV1 (volume of air forcefully exhaled in one second)
  • Methacholine PD20
    • Time Frame: 24 hours after last dose
    • dose of methacholine required to induce a 20% fall in FEV1 (volume of air forcefully exhaled in one second)

Participating in This Clinical Trial

Inclusion Criteria

  • airway responsiveness to methacholine
  • adequate baseline lung function
  • no respiratory infection or exposure to stimuli that may alter response to methacholine within 4 weeks

Exclusion Criteria

  • pregnancy
  • current smoker
  • requirement for medications other than salbutamol that will interfere with airway response to methacholine

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Saskatchewan
  • Provider of Information About this Clinical Study
    • Principal Investigator: Don Cockcroft, Professor – University of Saskatchewan
  • Overall Official(s)
    • Don Cockcroft, MD, Principal Investigator, University of Saskatchewan

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