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

NCT ID: NCT04167280

Last Updated: 2020-03-26

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-05

Study Completion Date

2020-03-13

Brief Summary

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

Detailed Description

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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.

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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Ipratropium bromide

20mcg bronchodilator inhaler

Group Type ACTIVE_COMPARATOR

Ipratropium Metered Dose Inhaler

Intervention Type DRUG

MDI to deliver 20mcg per puff ipratropium bromide

placebo

matching bronchodilator inhaler

Group Type PLACEBO_COMPARATOR

placebo metered dose inhaler

Intervention Type DRUG

matched MDI to deliver inactive drug

Interventions

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Ipratropium Metered Dose Inhaler

MDI to deliver 20mcg per puff ipratropium bromide

Intervention Type DRUG

placebo metered dose inhaler

matched MDI to deliver inactive drug

Intervention Type DRUG

Eligibility Criteria

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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
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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University of Saskatchewan

Saskatoon, Saskatchewan, Canada

Site Status

Countries

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Canada

Other Identifiers

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Bio REB 1522

Identifier Type: -

Identifier Source: org_study_id

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