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

September 28, 2012 updated by: AstraZeneca

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

742

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Symbicort
Symbicort pMDI 160/4.5 ug x 2 actuations twice daily (BID)
Drug: Budesonide/formoterol (SYMBICORT) pMDI
Symbicort pMDI 160/4.5 ug x 2 actuations twice daily (BID)
Experimental: Budesonide
Budesonide HFA pMDI 160 ug x 2 actuations BID
Drug: Budesonide HFA pMDI
Budesonide HFA pMDI 160 ug x 2 actuations BID

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
52 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Asthma Exacerbations
Time Frame: 52 Weeks
Number of participants with at least 1 exacerbation
52 Weeks
QT Interval Corrected Using the Fridericia Formula Measured Via Electrocardiogram (ECG)
Time Frame: Baseline and 52 weeks
QT interval corrected using the Fridericia formula [QTc (Frid)] - Change from baseline to end of treatment
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)
Total ectopic ventricular (VE) beats - number of participants with shift from normal (<50) to high (≥50) from baseline to visit 4.
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 ectopic supraventricular (VE) beats - number of participants with shift normal (<50) to high (≥50) from baseline to visit 4.
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)
Total ventricular runs - number of participants with shift normal (<1) to high (≥1) from baseline to week 2.
Baseline and 2 weeks (visit 4)
Diary Assessments - Rescue-free Day
Time Frame: baseline and 52 weeks
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
baseline and 52 weeks
Diary Assessments - Symptom-free Day
Time Frame: baseline and 52 weeks
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
baseline and 52 weeks
Diary Assessments - Asthma-control Day
Time Frame: baseline and 52 weeks
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
baseline and 52 weeks
Onset of Effect Questionnaire (OEQ)
Time Frame: 1 week
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"
1 week
Onset of Effect Questionnaire (OEQ)
Time Frame: 1 week
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"
1 week
Peak Expiratory Flow (PEF) in Morning
Time Frame: baseline and 52 weeks
Change in AM PEF from baseline (mean over the 2 weeks run-in) to the average of the randomized treatment period.
baseline and 52 weeks
Forced Expiratory Volume in One Second (FEV1)
Time Frame: baseline and 52 weeks
Change in pre-dose FEV1 from baseline (end of run-in, visit 3) to the average of the randomized treatment period
baseline and 52 weeks
Asthma Treatment Satisfaction Measure (ATSM)
Time Frame: Baseline and 52 weeks
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.
Baseline and 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Christer Hultquist, MD, AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

January 5, 2007

First Submitted That Met QC Criteria

January 5, 2007

First Posted (Estimate)

January 9, 2007

Study Record Updates

Last Update Posted (Estimate)

October 30, 2012

Last Update Submitted That Met QC Criteria

September 28, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D5896C00022

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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