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

NCT01218399 | Completed Results

• 2 other identifiers: SU-10042010-7010IRB 15128
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

Asthma

Outcome Measures

Primary Outcomes (1)

• 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

  1 week

Secondary Outcomes (1)

• Adverse Events

  1 week

Study Arms (2)

Budesonide

ACTIVE COMPARATOR

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

Placebo Comparator: Budesonide

PLACEBO COMPARATOR

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

Interventions

Symbicort DRUG

Also known as: Budesonide

Budesonide; Placebo Comparator: Budesonide

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• AstraZeneca: collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Budesonide, Formoterol Fumarate Drug Combination; Budesonide

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Formoterol Fumarate; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Elena Pizzi
• Organization: Astra Zeneca

Elena.Pizzi@astrazeneca.com

+1 302 885 2677

Study Officials

• Kari Christine Nadeau

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: October 7, 2010
• First Posted: October 11, 2010
• Study Start: September 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: August 18, 2017
• Results First Posted: August 18, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)