Use of Symbicort or Pulmicort to Treat Viral-mediated Asthma Exacerbations
Overview[ - collapse ][ - ]
| Purpose | 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. |
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| Condition | Asthma |
| Intervention | Drug: Symbicort vs Budesonide in treating acute respiratory illness |
| Phase | N/A |
| Sponsor | Stanford University |
| Responsible Party | Stanford University |
| ClinicalTrials.gov Identifier | NCT01218399 |
| First Received | October 7, 2010 |
| Last Updated | March 14, 2014 |
| Last verified | March 2014 |
Tracking Information[ + expand ][ + ]
| First Received Date | October 7, 2010 |
|---|---|
| Last Updated Date | March 14, 2014 |
| Start Date | September 2009 |
| Estimated Primary Completion Date | July 2010 |
| Current Primary Outcome Measures | asthma symptom scores [Time Frame: 1 week] [Designated as safety issue: No] |
| Current Secondary Outcome Measures | Enhanced glucocorticoid signaling pathways as shown by FACS and ImageStream [Time Frame: 1 week] [Designated as safety issue: No] |
Descriptive Information[ + expand ][ + ]
| Brief Title | Use of Symbicort or Pulmicort to Treat Viral-mediated Asthma Exacerbations |
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| 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 (160 mcg Budesonide/4.5 Formoterol, 2 Inhalations BID) or Pulmicort Flexhaler (160 mcg Budesonide, 2 Inhalations BID). |
| 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. We hypothesize that the budesonide/formoterol combination improves the efficacy of budesonide alone. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | N/A |
| Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment |
| Condition | Asthma |
| Intervention | Drug: Symbicort vs Budesonide in treating acute respiratory illness use of either symbicort or budesonide |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 30 |
| Estimated Completion Date | July 2010 |
| Estimated Primary Completion Date | July 2010 |
| Eligibility Criteria | Inclusion Criteria: Subjects will be considered for inclusion in this study based on meeting all of the following criteria: 1. Male or female, aged 12 to 65 years 2. Subjects with mild to moderate asthma as determined by NHLBI 2007 guidelines 3. Subjects with exacerbation of their asthma symptoms by NHLBI 2007 guidelines 4. IgE level at study entry less than 50 IU/mL 5. 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 6. 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. 7. Women of childbearing potential who have a negative pregnancy test (urine or serum) at the time of study entry 8. 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: 1. With a chronic or acute disease that might interfere with the evaluation of Symbicort or Pulmicort Flexhaler therapy 2. Pregnancy or lactation 3. Current or prior malignancies (excluding non-melanoma skin carcinoma or carcinoma in situ of the cervix that has been adequately treated) 4. History of infection with human immunodeficiency virus (HSC-1), hepatitis B virus (HBV), or hepatitis C virus (HCV); or Hepatitis A virus (HAV) 5. Infections that require intravenous antibiotic therapy 6. 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) 7. Treatment with a humanized or chimeric antibody therapy within 4 weeks prior to study entry 8. Treatment with any investigational drugs or therapies within 2 weeks prior to study entry 9. Any use of oral, systemic corticosteroids within 2 weeks prior to study entry |
| Gender | Both |
| Ages | 12 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01218399 |
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| Other Study ID Numbers | SU-10042010-7010 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Stanford University |
| Study Sponsor | Stanford University |
| Collaborators | AstraZeneca |
| Investigators | Principal Investigator: Kari Christine Nadeau Stanford University |
| Verification Date | March 2014 |
Locations[ + expand ][ + ]
| Stanford University School of Medicine | Stanford, California, United States, 94305 |
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