AsthmaPhase 3NCT00419952

A Comparison of SYMBICORT® pMDI With Budesonide HFA pMDI in African American Subjects With Asthma.

A Phase 3 study testing Budesonide/formoterol (SYMBICORT) pMDI and Budesonide HFA pMDI in people with Asthma, run by AstraZeneca at 122 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine the effectiveness and safety of SYMBICORT® pMDI (a medication approved by the Food and Drug Administration, FDA) in the African American population. Read more about this study

Who is it for?: Ages 12 years and older
Conditions the study is for: Asthma
What is being tested?: Budesonide/formoterol (SYMBICORT) pMDI and Budesonide HFA pMDI
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 742 participants
Where: 122 sitesUnited States
Study dates: Feb 2007to Nov 2009
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Male or Female, African American (self-reported), ≥12 years of age
Moderate to severe asthma requiring treatment with an inhaled corticosteroid
Diagnosis of asthma for at least 6 months

Who cannot join

Subjects requiring treatment with systemic corticosteroids (e.g., oral, parenteral, ocular)
Any significant disease or disorder that may jeopardize a subject's safety

Trial locations and contacts

122 sites in 1 country.

City, postcode or hospital

122 sites in 1 country

United States122 sites

Research Site
Albany, Georgia
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Altamonte Springs, Florida
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Asheville, North Carolina
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Atlanta, Georgia
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Augusta, Georgia
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Baltimore, Maryland
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Baton Rouge, Louisiana
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Bay City, Michigan
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Beaver, Pennsylvania
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Bethesda, Maryland
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Birmingham, Alabama
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Blackwood, New Jersey
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Bogalusa, Louisiana
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Brooklyn, New York
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Buena Park, California
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Charleston, South Carolina
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Charlotte, North Carolina
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Chattanooga, Tennessee
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Cherry Hill, New Jersey
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Chicago, Illinois
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Cincinnati, Ohio
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Clearwater, Florida
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Cleveland, Ohio
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Collegeville, Pennsylvania
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Colorado Springs, Colorado
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Columbia, South Carolina
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Columbus, Georgia
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Dallas, Texas
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Denver, Colorado
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Destin, Florida
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Foothill Ranch, California
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Gaffney, South Carolina
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Gainesville, Florida
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Gainesville, Georgia
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Greensboro, North Carolina
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Greenville, South Carolina
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Hampton, Virginia
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Harrisburg, Pennsylvania
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Havertown, Pennsylvania
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Hickory, North Carolina
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Highpoint, North Carolina
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Hollywood, Florida
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Houston, Texas
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Indianapolis, Indiana
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Killeen, Texas
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Little Rock, Arkansas
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Long Beach, California
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Los Angeles, California
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Lyndhurst, Ohio
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Marrero, Louisiana
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Merrillville, Indiana
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Metairie, Louisiana
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Miami, Florida
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Minneapolis, Minnesota
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Missouri City, Texas
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Mitchellville, Maryland
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Mobile, Alabama
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Monroe, Louisiana
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Montgomery, Alabama
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Montgomery Village, Maryland
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Mooresville, North Carolina
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Muscle Shoals, Alabama
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New Orleans, Louisiana
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New York, New York
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Newark, Delaware
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Newburgh, New York
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Norfolk, Virginia
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North Syracuse, New York
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Oklahoma City, Oklahoma
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Omaha, Nebraska
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Opa-locka, Florida
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Orlando, Florida
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Owensboro, Kentucky
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Parma, Ohio
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Paw Paw, Michigan
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Pensacola, Florida
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Peoria, Illinois
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Philadelphia, Pennsylvania
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Phoenix, Arizona
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Port Charlotte, Florida
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Prentiss, Mississippi
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Richmond, Virginia
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River Forest, Illinois
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Riverside, California
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Rochester, New York
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Rolling Hills Estates, California
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Russells Mills, Massachusetts
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Saginaw, Michigan
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San Antonio, Texas
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San Diego, California
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Savannah, Georgia
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Shreveport, Louisiana
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Simpsonville, South Carolina
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South Bend, Indiana
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South Miami, Florida
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Southfield, Michigan
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Spartanburg, South Carolina
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Springfield, Virginia
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Stockton, California
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Stone Mountain, Georgia
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Sugar Land, Texas
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Sugarland, Texas
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Sunset, Louisiana
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Tampa, Florida
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Teaneck, New Jersey
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The Bronx, New York
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Toledo, Ohio
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Tonawanda, New York
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Topeka, Kansas
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Torrance, California
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Union, South Carolina
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Upland, Pennsylvania
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Verona, New Jersey
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Vicksburg, Mississippi
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Waco, Texas
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Washington D.C., District of Columbia
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West Palm Beach, Florida
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Wheaton, Maryland
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Wichita, Kansas
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Winnetka, California
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Winston-Salem, North Carolina
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Yardley, Pennsylvania

Other trials in United States

About this study

Official title: A 52-week, Randomised, Double-blind, Parallel-group, Multi-centre, Phase IIIB Study Comparing the Long Term Safety of SYMBICORT® pMDI 160/4.5 mg x 2 Actuations Twice Daily to Budesonide HFA pMDI 160 mg x 2 Actuations Twice Daily in Adult/Adolescent (≥12 Years) African American Subjects With Asthma

The purpose of this study is to determine the effectiveness and safety of SYMBICORT® pMDI (a medication approved by the Food and Drug Administration, FDA) in the African American population.

Conditions: Asthma
Being tested: Budesonide/formoterol (SYMBICORT) pMDI, Budesonide HFA pMDI
Keywords: Moderate Asthma, Severe Asthma
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Budesonide/formoterol (SYMBICORT) pMDIDrug
Symbicort pMDI 160/4.5 ug x 2 actuations twice daily (BID)
Budesonide HFA pMDIDrug
Budesonide HFA pMDI 160 ug x 2 actuations BID

Study groups in NCT00419952
Study group	Role	What they receive
Symbicort	Experimental	Symbicort pMDI 160/4.5 ug x 2 actuations twice daily (BID) Receives: Drug: Budesonide/formoterol (SYMBICORT) pMDI
Budesonide	Experimental	Budesonide HFA pMDI 160 ug x 2 actuations BID Receives: Drug: Budesonide HFA pMDI

What is being measured

The primary outcome is the main question the study is designed to answer.

Total Number of Asthma Exacerbations
An exacerbation was defined as symptomatic worsening requiring oral/systemic glucocorticoid therapy and/or emergency room visit and/or urgent care center visit and/or hospitalization.
Measured: 52 Weeks

Secondary outcomes (13)

Asthma Exacerbations
Number of participants with at least 1 exacerbation
Measured: 52 Weeks
QT Interval Corrected Using the Fridericia Formula Measured Via Electrocardiogram (ECG)
QT interval corrected using the Fridericia formula [QTc (Frid)] - Change from baseline to end of treatment
Measured: Baseline and 52 weeks
Number of Patients With Shift From Normal to High Rate of Total Ectopic Ventricular Beats as Measured by 24-hour Holter Monitor Assessment
Total ectopic ventricular (VE) beats - number of participants with shift from normal (<50) to high (≥50) from baseline to visit 4.
Measured: Baseline and 2 weeks (visit 4)
Number of Patients With Shift From Normal to High Rate of Total Ectopic Supraventricular Beats as Measured by 24-hour Holter Monitor Assessment
Total ectopic supraventricular (VE) beats - number of participants with shift normal (<50) to high (≥50) from baseline to visit 4.
Measured: Baseline and 2 weeks (visit 4)
Total Number of Ventricular Runs as Measured by 24-hour Holter Monitor Assessment
Total ventricular runs - number of participants with shift normal (<1) to high (≥1) from baseline to week 2.
Measured: Baseline and 2 weeks (visit 4)
Diary Assessments - Rescue-free Day
Calculated as the number of rescue-free days divided by the number of non missing days in the baseline period times 100%. The results are expressed as the change in % rescue-free days in the baseline period and the active treatment period. A rescue-free day was one in which the patient answered "no" to having used rescue medication that day
Measured: baseline and 52 weeks
Diary Assessments - Symptom-free Day
Calculated as the number of symptom-free days divided by the number of non missing days in the baseline period times 100%. The results are expressed as the change in % symptom-free days in the baseline period and the active treatment period. A symptom-free day was one in which the patient answered "no" to having symptoms that day
Measured: baseline and 52 weeks
Diary Assessments - Asthma-control Day
Calculated as the number of asthma control days divided by the number of non missing days in the baseline period times 100%. The results are expressed as the change in % asthma control days in the baseline period and the active treatment period. An asthma control day was one in which the patient answered "no" to having symptoms and "0" to the use of rescue medication that day
Measured: baseline and 52 weeks
Onset of Effect Questionnaire (OEQ)
Number of participants with positive response to Item 2 in questionnaire "During the past week,you could feel your study medication begin to work right away. A positive response was defined as a response of "strongly agree" or "somewhat agree"
Measured: 1 week
Onset of Effect Questionnaire (OEQ)
Number of participants with positive response to Item 5 in questionnaire "During the past week, you were satisfied with how quickly you felt your study medication begin to work." The scale was scored on a 5-point Likert scale from strongly agree to strongly disagree. A positive response was defined as a response of "strongly agree" or "somewhat agree"
Measured: 1 week
Peak Expiratory Flow (PEF) in Morning
Change in AM PEF from baseline (mean over the 2 weeks run-in) to the average of the randomized treatment period.
Measured: baseline and 52 weeks
Forced Expiratory Volume in One Second (FEV1)
Change in pre-dose FEV1 from baseline (end of run-in, visit 3) to the average of the randomized treatment period
Measured: baseline and 52 weeks
Asthma Treatment Satisfaction Measure (ATSM)
Overall score - change from baseline to end of treatment. For 11 individual attributes, expectations were subtracted from the outcomes. This difference and the importance rating were combined in a weighted average which was then multiplied by the raw satisfaction measure. The final derived satisfaction measure was transformed to a 0 to 100 scale, with higher scores representing greater satisfaction.
Measured: Baseline and 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2007Nov 2009

First posted9 Jan 2007 (estimated)
Study startFeb 2007
Primary completionNov 2009
Study completionNov 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AsthmaStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 742 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00419952
Sponsor's protocol ID: D5896C00022
Status last verified: Sep 2012
First submitted: 5 Jan 2007
Last updated: 30 Oct 2012
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 30 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 52-week, Randomised, Double-blind, Parallel-group, Multi-centre, Phase IIIB Study Comparing the Long Term Safety of SYMBICORT® pMDI 160/4.5 mg x 2 Actuations Twice Daily to Budesonide HFA pMDI 160 mg x 2 Actuations Twice Daily in Adult/Adolescent (≥12 Years) African American Subjects With Asthma
ClinicalTrials.gov ID: NCT00419952
Acronym / sponsor ID: D5896C00022
Conditions: Asthma
Keywords: Moderate Asthma, Severe Asthma
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 742 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Feb 2007
Primary completion: Nov 2009 (actual)
Study completion: Nov 2009 (actual)
First posted: 9 Jan 2007 (estimated)
Results: Posted 30 Oct 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to determine the effectiveness and safety of SYMBICORT® pMDI (a medication approved by the Food and Drug Administration, FDA) in the African American population.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Symbicort	Experimental	Drug: Budesonide/formoterol (SYMBICORT) pMDISymbicort pMDI 160/4.5 ug x 2 actuations twice daily (BID)
Budesonide	Experimental	Drug: Budesonide HFA pMDIBudesonide HFA pMDI 160 ug x 2 actuations BID

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

Male or Female, African American (self-reported), ≥12 years of age
Moderate to severe asthma requiring treatment with an inhaled corticosteroid
Diagnosis of asthma for at least 6 months

Key exclusion criteria (2 listed)

Subjects requiring treatment with systemic corticosteroids (e.g., oral, parenteral, ocular)
Any significant disease or disorder that may jeopardize a subject's safety

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Budesonide/formoterol (SYMBICORT) pMDISymbicort pMDI 160/4.5 ug x 2 actuations twice daily (BID)	Drug	Symbicort
Budesonide HFA pMDIBudesonide HFA pMDI 160 ug x 2 actuations BID	Drug	Budesonide

Primary outcome

Total Number of Asthma Exacerbations
Time frame: 52 Weeks
An exacerbation was defined as symptomatic worsening requiring oral/systemic glucocorticoid therapy and/or emergency room visit and/or urgent care center visit and/or hospitalization.

13 secondary outcomes

Asthma Exacerbations
Time frame: 52 Weeks
QT Interval Corrected Using the Fridericia Formula Measured Via Electrocardiogram (ECG)
Time frame: Baseline and 52 weeks
Number of Patients With Shift From Normal to High Rate of Total Ectopic Ventricular Beats as Measured by 24-hour Holter Monitor Assessment
Time frame: Baseline and 2 weeks (visit 4)
Number of Patients With Shift From Normal to High Rate of Total Ectopic Supraventricular Beats as Measured by 24-hour Holter Monitor Assessment
Time frame: Baseline and 2 weeks (visit 4)
Total Number of Ventricular Runs as Measured by 24-hour Holter Monitor Assessment
Time frame: Baseline and 2 weeks (visit 4)
Diary Assessments - Rescue-free Day
Time frame: baseline and 52 weeks
Diary Assessments - Symptom-free Day
Time frame: baseline and 52 weeks
Diary Assessments - Asthma-control Day
Time frame: baseline and 52 weeks
Onset of Effect Questionnaire (OEQ)
Time frame: 1 week
Onset of Effect Questionnaire (OEQ)
Time frame: 1 week
Peak Expiratory Flow (PEF) in Morning
Time frame: baseline and 52 weeks
Forced Expiratory Volume in One Second (FEV1)
Time frame: baseline and 52 weeks
Asthma Treatment Satisfaction Measure (ATSM)
Time frame: Baseline and 52 weeks

Results and safety

Results posted to the registry on 30 Oct 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Symbicort	377	228
Budesonide	365	240

Primary outcome: Total Number of Asthma Exacerbations

Time frame: 52 Weeks. Number. Unit: Exacerbations

Measure	Symbicort n = 377	Budesonide n = 364
Value	36 (NA)	61 (NA)

Population analysed: The full analysis set, consisting of all randomized patients who received at least one dose of randomized study medication and for whom data were collected after randomization.

13 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Symbicort	12 of 377 (3.2%)	98 of 377 (26%)	Not reported
Budesonide	15 of 365 (4.1%)	84 of 365 (23%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

Related trials for Asthma

RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Christer Hultquist, MD study director

AstraZeneca

122 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Budesonide/formoterol (SYMBICORT) pMDI and Budesonide HFA pMDI in people with Asthma, run by AstraZeneca at 122 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 122 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Number of Asthma Exacerbations (time frame: 52 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00419952.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2012.