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Clinical Trials/NCT00890539
NCT00890539
Completed
Not Applicable

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

University of Saskatchewan1 site in 1 country15 target enrollmentFebruary 2009

Overview

Phase
Not Applicable
Intervention
Methacholine challenge
Conditions
Asthma
Sponsor
University of Saskatchewan
Enrollment
15
Locations
1
Primary Endpoint
Methacholine PC20
Status
Completed
Last Updated
16 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
February 2009
End Date
March 2009
Last Updated
16 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Eligibility Criteria

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.

Arms & Interventions

Quadrupling

methacholine challenge using quadrupling concentrations

Intervention: Methacholine challenge

doubling

doubling concentrations of methacholine

Intervention: Methacholine challenge

Outcomes

Primary Outcomes

Methacholine PC20

Time Frame: 1 week

Secondary Outcomes

  • Subject measure of breathlessness - modified Borg scale(1 week)

Study Sites (1)

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