The purpose of this study is to find out whether a difference between two doses of formoterol can be detected by methacholine challenge.
During the screening visit, subjects'vital signs (heart rate, blood pressure and temperature) will be measured and they will perform standard spirometry. If the results of this test are 70% of normal or greater, they will be examined by a physician, and blood (1 teaspoonful) and urine will be collected for routine laboratory tests (CBC and routine urinalysis). If they are a female, a pregnancy test will be performed. During the second visit, subjects will inhale 1 or 2 doses of formoterol, (Foradil Aerolizer 12 mcg/capsule) a long-acting bronchodilator and 1 hour later, perform a methacholine test. At the end of the methacholine test, they will be given albuterol to reverse the effects of methacholine. On the third study day, they will repeat the second visit but with the opposite dose of Foradil.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
37
a single dose of 24 mcg of formoterol delivered by dry powder inhaler (Twisthaler)
a single dose of 12 mcg of formoterol delivered by dry powder inhaler (Twisthaler)
subjects inhaled deeply and forcefully and held their breath for 10 seconds for each dose
University of Florida Asthma Research Lab
Gainesville, Florida, United States
Post-dose PC20
The PC20 is the provocational dose of methacholine causing a 20% drop in forced expiratory volume in the first second.
Time frame: 3-7 days after visits 1 and 2
FEV1
The forced expiratory volume in the first second, expressed as a percent predicted.
Time frame: 1 hour after dose
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