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Use of Symbicort or Pulmicort to Treat Viral-mediated Asthma Exacerbations

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Symbicort
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma

Eligibility Criteria

12 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Budesonide

Placebo Comparator: Budesonide

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Adverse Events
Number of adverse events as per MEDRA terms

Full Information

First Posted
October 7, 2010
Last Updated
July 18, 2017
Sponsor
Stanford University
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT01218399
Brief Title
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

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Budesonide
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo Comparator: Budesonide
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Symbicort
Other Intervention Name(s)
Budesonide
Primary Outcome Measure Information:
Title
Percent Forced Expiratory Volume in One Second (FEV1)
Description
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
Secondary Outcome Measure Information:
Title
Adverse Events
Description
Number of adverse events as per MEDRA terms
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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 Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kari Christine Nadeau
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Use of Symbicort or Pulmicort to Treat Viral-mediated Asthma Exacerbations

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