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

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01218399
First received: October 7, 2010
Last updated: March 14, 2014
Last verified: March 2014
  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 vs Budesonide in treating acute respiratory illness

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 (160 mcg Budesonide/4.5 Formoterol, 2 Inhalations BID) or Pulmicort Flexhaler (160 mcg Budesonide, 2 Inhalations BID).

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • asthma symptom scores [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Enhanced glucocorticoid signaling pathways as shown by FACS and ImageStream [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Enrollment: 30
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
Experimental: Symbicort
combination of budesonide and formoterol
Drug: Symbicort vs Budesonide in treating acute respiratory illness
use of either symbicort or budesonide
Active Comparator: budesonide
control of budesonide alone
Drug: Symbicort vs Budesonide in treating acute respiratory illness
use of either symbicort or budesonide

  Eligibility

Ages Eligible for Study:   12 Years to 65 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01218399     History of Changes
Other Study ID Numbers: SU-10042010-7010, IRB 15128
Study First Received: October 7, 2010
Last Updated: March 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by 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
Symbicort
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
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

ClinicalTrials.gov processed this record on July 31, 2014