This is an investigator-initiated study in which Dr. Nadeau wrote the protocol and received funding from an Astra Zeneca grant to direct, perform, and monitor the study on her own with Stanford staff. We hypothesize that the budesonide/formoterol combination improves the efficacy of budesonide alone.
The study was designed such that 30 participants would be consented/enrolled into the trial. The intervention would only be applied if the participant developed a viral illness that met eligibility criteria during the study period. Only 10 of the 30 ppt. consented/enrolled developed a virus and were then treated according to study arm. A more detailed description can be obtained by contacting Astra Zeneca
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
10
Stanford University School of Medicine
Stanford, California, United States
Percent Forced Expiratory Volume in One Second (FEV1)
Asthma symptoms scores reported as measure of FEV1 - Forced Expiratory Volume in one second * FEV1 is given which is a standard outcome in asthma studies and is validated by the NIH (NHLBI) * FEV1 of less than 80 is indicative of severe asthma, 80-90 is moderate asthma, over 90 is mild asthma http://www.med.umich.edu/1info/FHP/practiceguides/asthma/EPR-3\_pocket\_guide.pdf
Time frame: 1 week
Adverse Events
Number of adverse events as per MEDRA terms
Time frame: 1 week
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