Use of Symbicort or Pulmicort to Treat Viral-mediated Asthma Exacerbations
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
|Official Title:||A Randomized, Blinded, Single-center Study in Mild to Moderate Asthmatics Over the Age of 12 Years Who Have a Viral-mediated Exacerbation and Are Treated With Symbicort or Pulmicort Flexhaler|
- Percent Forced Expiratory Volume in One Second (FEV1) [ Time Frame: 1 week ]
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
- Adverse Events [ Time Frame: 1 week ]Number of adverse events as per MEDRA terms
|Study Start Date:||September 2009|
|Study Completion Date:||July 2010|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
Active Comparator: Budesonide
Combination of budesonide and formoterol. Medications are given according to the package insert and manufacturer's instructions.
Participants that develop a viral upper respiratory illness which induces an asthma exacerbation.within the specified period following enrollment, are randomly assigned 1:1 to either study arm. 5 participants were randomly assigned to the Symbicort study arm.
Other Name: Budesonide
Placebo Comparator: Placebo Comparator: Budesonide
Control of budesonide alone. Medication was given according to the package insert and manufacturer's instructions.
Participants that develop a viral upper respiratory illness which induces an asthma exacerbation.within the specified period following enrollment, are randomly assigned 1:1 to either study arm. 5 participants were randomly assigned to the Budesonide study arm.
Other Name: Budesonide
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01218399
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Kari Christine Nadeau||Stanford University|