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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00890539
Enrollment
15
Registered
2009-04-30
Start date
2009-02-28
Completion date
2009-03-31
Last updated
2009-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

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.

Interventions

Clinical and research test used in asthma

Sponsors

University of Saskatchewan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Methacholine PC201 week

Secondary

MeasureTime frame
Subject measure of breathlessness - modified Borg scale1 week

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026