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| ID | Type | Description | Link |
|---|---|---|---|
| IRB 15128 |
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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Budesonide | Active Comparator | Combination of budesonide and formoterol. Medications are given according to the package insert and manufacturer's instructions. Participants that develop a viral upper respiratory illness which induces an asthma exacerbation.within the specified period following enrollment, are randomly assigned 1:1 to either study arm. 5 participants were randomly assigned to the Symbicort study arm. |
|
| Placebo Comparator: Budesonide | Placebo Comparator | Control of budesonide alone. Medication was given according to the package insert and manufacturer's instructions. Participants that develop a viral upper respiratory illness which induces an asthma exacerbation.within the specified period following enrollment, are randomly assigned 1:1 to either study arm. 5 participants were randomly assigned to the Budesonide study arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Symbicort | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Forced Expiratory Volume in One Second (FEV1) | Asthma symptoms scores reported as measure of FEV1 - Forced Expiratory Volume in one second
http://www.med.umich.edu/1info/FHP/practiceguides/asthma/EPR-3\_pocket\_guide.pdf | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Number of adverse events as per MEDRA terms | 1 week |
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Inclusion Criteria:
Subjects will be considered for inclusion in this study based on meeting all of the following criteria:
Exclusion Criteria:
Subjects will be ineligible for this study based on any one of the following criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kari Christine Nadeau | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Symbicort | Combination of budesonide and formoterol Symbicort will be given as per product insert (2 puffs twice daily of 160/4.5 Budesonide/formoterol) |
| FG001 | Budesonide | Control of budesonide alone Pulmicort Flexhaler will be given as per product insert (2 puffs twice daily of 160 mcg) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Symbicort | combination of budesonide and formoterol Symbicort vs Budesonide in treating acute respiratory illness: use of either symbicort or budesonide |
| BG001 | Budesonide | control of budesonide alone Symbicort vs Budesonide in treating acute respiratory illness: use of either symbicort or budesonide |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Forced Expiratory Volume in One Second (FEV1) | Asthma symptoms scores reported as measure of FEV1 - Forced Expiratory Volume in one second
http://www.med.umich.edu/1info/FHP/practiceguides/asthma/EPR-3\_pocket\_guide.pdf | Posted | Mean | Standard Deviation | % FEV1 | 1 week |
|
Data was collected for a year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Symbicort | combination of budesonide and formoterol Symbicort vs Budesonide in treating acute respiratory illness: use of either symbicort or budesonide |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elena Pizzi | Astra Zeneca | +1 302 885 2677 | Elena.Pizzi@astrazeneca.com |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D000069502 | Budesonide, Formoterol Fumarate Drug Combination |
| D019819 | Budesonide |
| ID | Term |
|---|---|
| D000068759 | Formoterol Fumarate |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
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| Secondary | Adverse Events | Number of adverse events as per MEDRA terms | Posted | Number | Number adverse events | 1 week |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Budesonide | control of budesonide alone Symbicort vs Budesonide in treating acute respiratory illness: use of either symbicort or budesonide | 0 | 10 | 0 | 10 | 0 | 10 |
Please contact the sponsor Astra Zeneca for the agreement
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D009930 |
| Organic Chemicals |
| D000588 | Amines |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |