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

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

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