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

March 25, 2020 updated by: Don Cockcroft, University of Saskatchewan
Study is looking at the development of tolerance to methacholine following regular use of ipratropium bromide in mild asthmatics.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 0W8
        • University of Saskatchewan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Ipratropium bromide
20mcg bronchodilator inhaler
Drug: Ipratropium Metered Dose Inhaler
MDI to deliver 20mcg per puff ipratropium bromide
PLACEBO_COMPARATOR: placebo
matching bronchodilator inhaler
Drug: placebo metered dose inhaler
matched MDI to deliver inactive drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Pre treatment
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)
Day 7 after starting treatment
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)
24 hours after last dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Saskatchewan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 5, 2019

Primary Completion (ACTUAL)

March 13, 2020

Study Completion (ACTUAL)

March 13, 2020

Study Registration Dates

First Submitted

November 13, 2019

First Submitted That Met QC Criteria

November 14, 2019

First Posted (ACTUAL)

November 18, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 26, 2020

Last Update Submitted That Met QC Criteria

March 25, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bio REB 1522

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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