Status:
COMPLETED
The Impact of Dosimeter on Measurement of Airway Responsiveness to Methacholine
Lead Sponsor:
University of Florida
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Asthma
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
End Date :
December 1 2005
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00145990
Start Date
September 1 2005
End Date
December 1 2005
Last Update
March 5 2012
Active Locations (1)
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1
University of Florida Asthma Research Lab
Gainesville, Florida, United States, 32610