The Impact of Dosimeter on Measurement of Airway Responsiveness to Methacholine

Completed · Not applicable

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT00145990

Run by

University of Florida

People needed

12

Starts

2005-09-01

Expected to finish

2005-12-01

Last updated by the study team

2012-03-05

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Florida Asthma Research Lab — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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