Use of Symbicort or Pulmicort to Treat Viral-mediated Asthma Exacerbations

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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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

Conditions
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Asthma

Intervention / Treatment
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* Drug: Symbicort


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects will be considered for inclusion in this study based on meeting all of the following criteria: Male or female, aged 12 to 65 years Subjects with mild to moderate asthma as determined by NHLBI 2007 guidelines Subjects with exacerbation of their asthma symptoms by NHLBI 2007 guidelines IgE level at study entry less than 50 IU/mL Men and women of reproductive potential who document use of adequate contraception during the study and for 3 months after the conclusion of treatment with study drug/placebo Historical documentation of asthma in the patient's medical record. The patient should have 6 months or more of asthma medication and management by a Stanford physician. Women of childbearing potential who have a negative pregnancy test (urine or serum) at the time of study entry Subject's guardians who are capable of understanding the purpose and risks of the study and who sign a statement of informed consent for the study Exclusion Criteria: Subjects will be ineligible for this study based on any one of the following criteria: With a chronic or acute disease that might interfere with the evaluation of Symbicort or Pulmicort Flexhaler therapy Pregnancy or lactation Current or prior malignancies (excluding non-melanoma skin carcinoma or carcinoma in situ of the cervix that has been adequately treated) History of infection with human immunodeficiency virus (HSC-1), hepatitis B virus (HBV), or hepatitis C virus (HCV); or Hepatitis A virus (HAV) Infections that require intravenous antibiotic therapy Significant organ dysfunction, including cardiac, renal, liver, CNS, pulmonary, vascular, gastrointestinal, endocrine, or metabolic (e.g., creatinine >1.6 mg/dL; ALT or AST > 1.5x the upper limit of normal; history of myocardial infarction, congestive heart failure, or arrhythmias within 6 months prior to study entry) Treatment with a humanized or chimeric antibody therapy within 4 weeks prior to study entry Treatment with any investigational drugs or therapies within 2 weeks prior to study entry Any use of oral, systemic corticosteroids within 2 weeks prior to study entry

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Budesonide<br>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. | Drug: Symbicort<br> <br> * Other names: Budesonide;|
| Placebo Comparator: Placebo Comparator: Budesonide<br>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. | Drug: Symbicort<br> <br> * Other names: Budesonide;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Number of adverse events as per MEDRA terms | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma