Status:
COMPLETED
Use of Symbicort or Pulmicort to Treat Viral-mediated Asthma Exacerbations
Lead Sponsor:
Stanford University
Collaborating Sponsors:
AstraZeneca
Conditions:
Asthma
Eligibility:
All Genders
12-65 years
Phase:
NA
Brief Summary
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....
Detailed Description
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 cr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01218399
Start Date
September 1 2009
End Date
July 1 2010
Last Update
August 18 2017
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305