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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01218399
First Posted: October 11, 2010
Last Update Posted: August 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Kari Christine Nadeau, Stanford University
  Purpose
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.

Condition Intervention
Asthma Drug: Symbicort

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Kari Christine Nadeau, Stanford University:

Primary Outcome Measures:
  • 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



Secondary Outcome Measures:
  • Adverse Events [ Time Frame: 1 week ]
    Number of adverse events as per MEDRA terms


Enrollment: 10
Study Start Date: September 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Budesonide

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.

Drug: Symbicort
Other Name: Budesonide
Placebo Comparator: Placebo Comparator: Budesonide

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.

Drug: Symbicort
Other Name: Budesonide

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01218399


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
AstraZeneca
Investigators
Principal Investigator: Kari Christine Nadeau Stanford University
  More Information

Responsible Party: Kari Christine Nadeau, Principle Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT01218399     History of Changes
Other Study ID Numbers: SU-10042010-7010
IRB 15128
First Submitted: October 7, 2010
First Posted: October 11, 2010
Results First Submitted: January 23, 2015
Results First Posted: August 18, 2017
Last Update Posted: August 18, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Kari Christine Nadeau, Stanford University:
Asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Budesonide, Formoterol Fumarate Drug Combination
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists