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

NCT00890539 | Completed

• 1 other identifier: BMC08-247
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Methacholine PC20

  1 week

Secondary Outcomes (1)

• Subject measure of breathlessness - modified Borg scale

  1 week

Study Arms (2)

Quadrupling

EXPERIMENTAL

methacholine challenge using quadrupling concentrations

Drug: Methacholine challenge

doubling

ACTIVE COMPARATOR

doubling concentrations of methacholine

Drug: Methacholine challenge

Interventions

Methacholine challenge DRUG

Clinical and research test used in asthma

Quadrupling; doubling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Saskatchewan: lead

Study Sites (1)

University of Saskatchewan

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Donald W Cockcroft, MD

  University of Saskatchewan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 2, 2009
• First Posted: April 30, 2009
• Study Start: February 1, 2009
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: November 25, 2009

Record last verified: 2009-11

Locations

CA (1)