Clinical trial NCT01218399: Use of Symbicort or Pulmicort to Treat Viral-mediated Asthma Exacerbations
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Asthma
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2010-10-11
Enrollment: 10
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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: 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

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

Primary outcomes:
measure: Percent Forced Expiratory Volume in One Second (FEV1)
timeFrame: 1 week
Secondary outcomes:
measure: Adverse Events
timeFrame: 1 week
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Kari Christine Nadeau
role: PRINCIPAL_INVESTIGATOR
References: