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

NCT ID: NCT01218399

Last Updated: 2017-08-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2010-07-31

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

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Symbicort

Intervention Type: DRUG

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.

Group Type: PLACEBO_COMPARATOR

Symbicort

Intervention Type: DRUG

Interventions

Symbicort

Intervention Type: DRUG

Other Intervention Names

Budesonide

Eligibility 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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Kari Christine Nadeau

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kari Christine Nadeau

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

Other Identifiers

IRB 15128

Identifier Type: -

Identifier Source: secondary_id

SU-10042010-7010

Identifier Type: -

Identifier Source: org_study_id