Use of Symbicort or Pulmicort to Treat Viral-mediated Asthma Exacerbations
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|ClinicalTrials.gov Identifier: NCT01218399|
Recruitment Status : Completed
First Posted : October 11, 2010
Results First Posted : August 18, 2017
Last Update Posted : August 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: Symbicort||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||July 2010|
|Actual Study Completion Date :||July 2010|
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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01218399
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Kari Christine Nadeau||Stanford University|