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Methacholine Challenge: Comparison of Doubling and Quadrupling Methacholine Dose Regimes Using the Tidal Volume Method

NCT ID: NCT00890539

Last Updated: 2009-11-25

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

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2009-03-31

Brief Summary

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The purpose of this study is to determine the difference (if any) in the result of the methacholine challenge (a test used by physicians in diagnosing asthma) when concentrations of methacholine are quadrupled versus doubled.

Detailed Description

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The purpose of this study is to confirm that the tidal volume technique of methacholine delivery may be employed in methacholine challenges using a quadrupling dose schedule instead of the standard doubling dose schedule with similar diagnostic efficacy, with no increase in patient adverse events, and with a shorter investigational duration. This has previously been shown to be true using the dosimeter technique of methacholine challenge.

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Quadrupling

methacholine challenge using quadrupling concentrations

Group Type EXPERIMENTAL

Methacholine challenge

Intervention Type DRUG

Clinical and research test used in asthma

doubling

doubling concentrations of methacholine

Group Type ACTIVE_COMPARATOR

Methacholine challenge

Intervention Type DRUG

Clinical and research test used in asthma

Interventions

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Methacholine challenge

Clinical and research test used in asthma

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* You must be over 18 years of age; and
* You must have a diagnosis of asthma; and
* Excluding asthma, you are not aware of any other lung conditions or diseases.

Exclusion Criteria

* You have a known hypersensitivity (i.e. an overreaction of your immune system) to methacholine or other parasympathomimetic agents or cholinesterase inhibitors (i.e. agents that act in a similar way via your nervous system - to be discussed with study personnel); or
* You are a nursing mother or if you are a woman of child bearing potential who is, may be, or intends to become pregnant during testing as the effects of methacholine inhalation in these situations are not known; or
* Your baseline lung function is poor (ie. your FEV or forced expiratory volume in one second, is less than 65% of your predicted values). This will be performed and explained by study personnel prior to commencing methacholine inhalation testing; or
* You have had any respiratory infections for the last four weeks; or
* If you have allergies, and have been exposed to agents that trigger your asthma within the last four weeks; or
* If you have any significant chronic medical condition.
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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University of Saskatchewan

Principal Investigators

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Donald W 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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BMC08-247

Identifier Type: -

Identifier Source: org_study_id