The Impact of Dosimeter on Measurement of Airway Responsiveness to Methacholine

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00145990
First received: September 1, 2005
Last updated: March 1, 2012
Last verified: March 2012
  Purpose

To determine whether there is a difference in two different breathing tests used to detect asthma. Hypothesis: The Digidoser delivers less methacholine to the airways and will result in a higher PC20 than the value determined by the Rosenthal Dosimeter.


Condition Intervention
Asthma
Drug: methacholine
Device: KoKo Digidoser
Device: Rosethal Dosimeter

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Geometric mean PC20 methacholine for each dosimeter method.

Estimated Enrollment: 12
Study Start Date: September 2005
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Detailed Description:

Bronchoprovocation with methacholine is used to confirm the diagnosis of asthma. The procedure involves inhaling methacholine through a nebulizer attached to a dosimeter that delivers a precise volume of methacholine. The endpoint of the test is the provocational concentration that produces a 20% decrease in FEV1 (PC20). To standardize the procedure, the American Thoracic Society (ATS) recommends that the nebulizer output be calibrated to deliver an output of 0.9 ± 0.09 mL/min.

The Rosenthal Dosimeter and the KoKo Digidoser are two commonly used dosimeters. In an attempt to follow the ATS guideline we discovered that the nebulizer output was lower with the KoKo Digidoser and could not be calibrated. However, it is unclear whether the apparent lower output is a result of the Digidoser delivering less solution or that the ATS method of determining output is not applicable to this dosimeter. To answer this question, we propose to determine the methacholine PC20 in subjects with asthma using the two dosimeters. It is our hypothesis that the Digidoser delivers less methacholine and thus will produce a higher PC20 than the Rosenthal Dosimeter.

Twelve nonsmoking subjects with mild asthma will be selected on the basis of > 18 years of age, a baseline FEV1 of > 60% predicted and a screening PC20 of < 8mg/ml. Subjects will be randomized to perform a methacholine challenge with the Digidoser and the Rosenthal Dosimeter on two different days in an unblinded, crossover manner. The geometric mean PC20 with each dosimeter will be compared with a paired t test. The results of this study will indicate whether the Digidoser has the potential of causing false negative test results or whether the ATS method of determining output should not be used with this dosimeter.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Non-smoking male or female >18 years of age, with a previous diagnosis of asthma.
  • Women of child bearing age must not be pregnant or nursing and be using an acceptable method of contraception.
  • Screening FEV1 > 70% of predicted for height, age, sex, and race when bronchodilators are withheld for appropriate intervals.
  • At least a 20% decrease in FEV1 after inhaling ≤ 8 mg/ml of methacholine (i.e., a PC20 FEV1 ≤8 mg/ml) using the KoKo Digidoser system.
  • Ability to perform ATS-acceptable and reproducible spirometry.

Exclusion Criteria:

  • Cigarette smoking in past year or > 10 pack year smoking history.
  • Respiratory tract infection within the last four weeks.
  • History of severe asthma attack requiring hospitalization in the previous 12 months.
  • Short course of oral corticosteroids in the past 3 weeks.
  • Inability to withhold caffeinated beverages for 12 hours or medications for appropriate intervals prior to each methacholine challenge.
  • If female, a positive urine β-HCG test.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00145990

Locations
United States, Florida
University of Florida Asthma Research Lab
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
GlaxoSmithKline
Investigators
Principal Investigator: Yasmeen Khan, MD University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00145990     History of Changes
Other Study ID Numbers: 257-2005
Study First Received: September 1, 2005
Last Updated: March 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
methacholine PC20
dosimeter
asthma

Additional relevant MeSH terms:
Methacholine Chloride
Miotics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Parasympathomimetics
Bronchoconstrictor Agents
Respiratory System Agents
Therapeutic Uses
Muscarinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014