Asthma
Conditions
Keywords
Asthma
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
Interventions
DRUGSymbicort
Sponsors
AstraZeneca
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
12 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Forced Expiratory Volume in One Second (FEV1) | 1 week | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 1 week | Number of adverse events as per MEDRA terms |
Countries
United States
Participant flow
Pre-assignment details
Participants that contract a viral upper respiratory illness which induces an asthma exacerbation and meets eligibility criteria will be randomized at Day 1 to either Symbicort or Budesonide in a 1:1 randomization. 5 participants were randomly assigned to the Symbicort study arm, and 5 participants were assigned to the Budesonide study arm.
Participants by arm
| Arm | Count |
|---|---|
| Symbicort combination of budesonide and formoterol
Symbicort vs Budesonide in treating acute respiratory illness: use of either symbicort or budesonide | 5 |
| Budesonide control of budesonide alone
Symbicort vs Budesonide in treating acute respiratory illness: use of either symbicort or budesonide | 5 |
| Total | 10 |
Baseline characteristics
| Characteristic | Budesonide | Symbicort | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 5 Participants | 10 Participants |
| Age, Continuous | 25 years STANDARD_DEVIATION 6 | 24 years STANDARD_DEVIATION 5 | 24 years STANDARD_DEVIATION 5 |
| Region of Enrollment United States | 5 participants | 5 participants | 10 participants |
| Sex: Female, Male Female | 3 Participants | 2 Participants | 5 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
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
Time frame: 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Symbicort | Percent Forced Expiratory Volume in One Second (FEV1) | 90 % FEV1 | Standard Deviation 13 |
| Budesonide | Percent Forced Expiratory Volume in One Second (FEV1) | 88 % FEV1 | Standard Deviation 14 |
Secondary
Adverse Events
Number of adverse events as per MEDRA terms
Time frame: 1 week
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Symbicort | Adverse Events | 0 Number adverse events |
| Budesonide | Adverse Events | 0 Number adverse events |