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

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Methacholine challenge

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.

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Quadrupling; methacholine challenge using quadrupling concentrations	Drug: Methacholine challenge; Clinical and research test used in asthma
Active Comparator: doubling; doubling concentrations of methacholine	Drug: Methacholine challenge; Clinical and research test used in asthma

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Methacholine PC20	1 week

Secondary Outcome Measures

Outcome Measure	Time Frame
Subject measure of breathlessness - modified Borg scale	1 week

Collaborators and Investigators

• Sponsor: University of Saskatchewan

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: March 2, 2009
• First Submitted That Met QC Criteria: April 29, 2009
• First Posted (Estimate): April 30, 2009

Study Record Updates

• Last Update Posted (Estimate): November 25, 2009
• Last Update Submitted That Met QC Criteria: November 23, 2009
• Last Verified: November 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Cholinergic Agonists; Respiratory System Agents; Miotics; Parasympathomimetics; Bronchoconstrictor Agents; Muscarinic Agonists; Methacholine Chloride
• Other Study ID Numbers: BMC08-247

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