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

Asthma Clinical Trial

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01218399
• Other study ID #: SU-10042010-7010
• Secondary ID: IRB 15128
• Status: Completed
• Phase: N/A
• First received: October 7, 2010
• Last updated: March 14, 2014
• Start date: September 2009
• Est. completion date: July 2010

Study information

• Verified date: March 2014
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Symbicort vs Budesonide in treating acute respiratory illness
use of either symbicort or budesonide

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	asthma symptom scores		1 week	No
Secondary	Enhanced glucocorticoid signaling pathways as shown by FACS and ImageStream		1 week	No