AsthmaNCT01218399
Use of Symbicort or Pulmicort to Treat Viral-mediated Asthma Exacerbations
A study testing Symbicort in people with Asthma, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- Symbicort
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Jul 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
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
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.
Read the 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
- Conditions
- Asthma
- Being tested
- Symbicort
- Keywords
- Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SymbicortDrug
Also called Budesonide
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Symbicort |
| 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. Receives: Drug: Symbicort |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 week
Secondary outcomes (1)
Adverse Events
Number of adverse events as per MEDRA terms
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2010 (estimated)
- Study startSep 2009
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Principal investigator, Kari Christine Nadeau, Stanford University
- Investigators
- Kari Christine Nadeau, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01218399
- Sponsor's protocol ID
- SU-10042010-7010
- Other IDs
- IRB 15128
- Status last verified
- Jun 2017
- First submitted
- 7 Oct 2010
- Last updated
- 18 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01218399
- Acronym / sponsor ID
- SU-10042010-7010
- Conditions
- Asthma
- Keywords
- Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Sep 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 11 Oct 2010 (estimated)
- Results
- Posted 18 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Budesonide | Active comparator | Drug: SymbicortCombination 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 | Drug: SymbicortControl 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. |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SymbicortAlso: Budesonide | Drug | Budesonide, Placebo Comparator: Budesonide |
Primary outcome
Percent Forced Expiratory Volume in One Second (FEV1)
Time frame: 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
1 secondary outcome
Adverse Events
Time frame: 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kari Christine Nadeau principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Symbicort in people with Asthma, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Forced Expiratory Volume in One Second (FEV1) (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2017.