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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
742

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 5, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 9, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 30, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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Conditions

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