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

• Sponsor: Stanford University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01218399
• Collaborator: AstraZeneca (Industry)
• Enrollment: 10
• Location: 1
• Arms: 2
• Duration (Months): 10
• Patients Per Site Per Month: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Asthma	Drug: Symbicort	N/A

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• 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
• Study Start Date: Sep 1, 2009
• Actual Primary Completion Date: Jul 1, 2010
• Actual Study Completion Date: Jul 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: Budesonide

Outcome Measures

Primary Outcome Measures

1. Percent Forced Expiratory Volume in One Second (FEV1) [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

1. Adverse Events [1 week]

   Number of adverse events as per MEDRA terms

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Stanford University School of Medicine	Stanford	California	United States	94305

Sponsors and Collaborators

• Stanford University
• AstraZeneca

Investigators

• Principal Investigator: Kari Christine Nadeau, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kari Christine Nadeau, Principle Investigator, Stanford University
• ClinicalTrials.gov Identifier: NCT01218399
• Other Study ID Numbers: SU-10042010-7010; IRB 15128
• First Posted: Oct 11, 2010
• Last Update Posted: Aug 18, 2017
• Last Verified: Jun 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Kari Christine Nadeau, Principle Investigator, Stanford University: Asthma
• Additional relevant MeSH terms: Asthma; Budesonide; Budesonide, Formoterol Fumarate Drug Combination

Study Results

Participant Flow

Pre-assignment Detail	Participants that contract a viral upper respiratory illness which induces an asthma exacerbation and meets eligibility criteria will be randomized at Day 1 to either Symbicort or Budesonide in a 1:1 randomization. 5 participants were randomly assigned to the Symbicort study arm, and 5 participants were assigned to the Budesonide study arm.

Arm/Group Title	Symbicort	Budesonide
Arm/Group Description	Combination of budesonide and formoterol Symbicort will be given as per product insert (2 puffs twice daily of 160/4.5 Budesonide/formoterol)	Control of budesonide alone Pulmicort Flexhaler will be given as per product insert (2 puffs twice daily of 160 mcg)
Period Title: Overall Study
STARTED	5	5
COMPLETED	5	5
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Symbicort	Budesonide	Total
Arm/Group Description	combination of budesonide and formoterol Symbicort vs Budesonide in treating acute respiratory illness: use of either symbicort or budesonide	control of budesonide alone Symbicort vs Budesonide in treating acute respiratory illness: use of either symbicort or budesonide	Total of all reporting groups
Overall Participants	5	5	10
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	5 100%	5 100%	10 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	24 (5)	25 (6)	24 (5)
Sex: Female, Male (Count of Participants)
Female	2 40%	3 60%	5 50%
Male	3 60%	2 40%	5 50%
Region of Enrollment (participants) [Number]
United States	5 100%	5 100%	10 100%

Outcome Measures

1. Primary Outcome

Title	Percent Forced Expiratory Volume in One Second (FEV1)
Description	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
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Symbicort	Budesonide
Arm/Group Description	combination of budesonide and formoterol Symbicort vs Budesonide in treating acute respiratory illness: use of either symbicort or budesonide	control of budesonide alone Symbicort vs Budesonide in treating acute respiratory illness: use of either symbicort or budesonide
Measure Participants	5	5
Mean (Standard Deviation) [% FEV1]	90 (13)	88 (14)

2. Secondary Outcome

Title	Adverse Events
Description	Number of adverse events as per MEDRA terms
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Symbicort	Budesonide
Arm/Group Description	combination of budesonide and formoterol Symbicort vs Budesonide in treating acute respiratory illness: use of either symbicort or budesonide	control of budesonide alone Symbicort vs Budesonide in treating acute respiratory illness: use of either symbicort or budesonide
Measure Participants	5	5
Number [Number adverse events]	0	0

Adverse Events

Time Frame	Data was collected for a year
Arm/Group Title	Symbicort		Budesonide
Arm/Group Description	combination of budesonide and formoterol Symbicort vs Budesonide in treating acute respiratory illness: use of either symbicort or budesonide		control of budesonide alone Symbicort vs Budesonide in treating acute respiratory illness: use of either symbicort or budesonide
All Cause Mortality
	Symbicort		Budesonide
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)
Serious Adverse Events
	Symbicort		Budesonide
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	Symbicort		Budesonide
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Please contact the sponsor Astra Zeneca for the agreement