Asthma Clinical Trial
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
| Verified date | September 2012 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 742 |
| Est. completion date | November 2009 |
| Est. primary completion date | November 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 12 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Research Site | Albany | Georgia |
| United States | Research Site | Altamonte Springs | Florida |
| United States | Research Site | Asheville | North Carolina |
| United States | Research Site | Atlanta | Georgia |
| United States | Research Site | Augusta | Georgia |
| United States | Research Site | Baltimore | Maryland |
| United States | Research Site | Baton Rouge | Louisiana |
| United States | Research Site | Bay City | Michigan |
| United States | Research Site | Beaver | Pennsylvania |
| United States | Research Site | Bethesda | Maryland |
| United States | Research Site | Birmingham | Alabama |
| United States | Research Site | Blackwood | New Jersey |
| United States | Research Site | Bogalusa | Louisiana |
| United States | Research Site | Bronx | New York |
| United States | Research Site | Brooklyn | New York |
| United States | Research Site | Buena Park | California |
| United States | Research Site | Charleston | South Carolina |
| United States | Research Site | Charlotte | North Carolina |
| United States | Research Site | Chattanooga | Tennessee |
| United States | Research Site | Cherry Hill | New Jersey |
| United States | Research Site | Chicago | Illinois |
| United States | Research Site | Cincinnati | Ohio |
| United States | Research Site | Clearwater | Florida |
| United States | Research Site | Cleveland | Ohio |
| United States | Research Site | Collegeville | Pennsylvania |
| United States | Research Site | Colorado Springs | Colorado |
| United States | Research Site | Columbia | South Carolina |
| United States | Research Site | Columbus | Georgia |
| United States | Research Site | Dallas | Texas |
| United States | Research Site | Dartmouth | Massachusetts |
| United States | Research Site | Denver | Colorado |
| United States | Research Site | Destin | Florida |
| United States | Research Site | Foothill Ranch | California |
| United States | Research Site | Gaffney | South Carolina |
| United States | Research Site | Gainesville | Florida |
| United States | Research Site | Gainesville | Georgia |
| United States | Research Site | Greensboro | North Carolina |
| United States | Research Site | Greenville | South Carolina |
| United States | Research Site | Hampton | Virginia |
| United States | Research Site | Harrisburg | Pennsylvania |
| United States | Research Site | Havertown | Pennsylvania |
| United States | Research Site | Hickory | North Carolina |
| United States | Research Site | Highpoint | North Carolina |
| United States | Research Site | Hollywood | Florida |
| United States | Research Site | Houston | Texas |
| United States | Research Site | Indianapolis | Indiana |
| United States | Research Site | Killeen | Texas |
| United States | Research Site | Little Rock | Arkansas |
| United States | Research Site | Long Beach | California |
| United States | Research Site | Los Angeles | California |
| United States | Research Site | Lyndhurst | Ohio |
| United States | Research Site | Marrero | Louisiana |
| United States | Research Site | Merrillville | Indiana |
| United States | Research Site | Metairie | Louisiana |
| United States | Research Site | Miami | Florida |
| United States | Research Site | Minneapolis | Minnesota |
| United States | Research Site | Missouri City | Texas |
| United States | Research Site | Mitchellville | Maryland |
| United States | Research Site | Mobile | Alabama |
| United States | Research Site | Monroe | Louisiana |
| United States | Research Site | Montgomery | Alabama |
| United States | Research Site | Montgomery Village | Maryland |
| United States | Research Site | Mooresville | North Carolina |
| United States | Research Site | Muscle Shoals | Alabama |
| United States | Research Site | New Orleans | Louisiana |
| United States | Research Site | New York | New York |
| United States | Research Site | Newark | Delaware |
| United States | Research Site | Newburgh | New York |
| United States | Research Site | Norfolk | Virginia |
| United States | Research Site | North Syracuse | New York |
| United States | Research Site | Oklahoma City | Oklahoma |
| United States | Research Site | Omaha | Nebraska |
| United States | Research Site | Opa Locka | Florida |
| United States | Research Site | Orlando | Florida |
| United States | Research Site | Owensboro | Kentucky |
| United States | Research Site | Parma | Ohio |
| United States | Research Site | Paw Paw | Michigan |
| United States | Research Site | Pensacola | Florida |
| United States | Research Site | Peoria | Illinois |
| United States | Research Site | Philadelphia | Pennsylvania |
| United States | Research Site | Phoenix | Arizona |
| United States | Research Site | Port Charlotte | Florida |
| United States | Research Site | Prentiss | Mississippi |
| United States | Research Site | Richmond | Virginia |
| United States | Research Site | River Forest | Illinois |
| United States | Research Site | Riverside | California |
| United States | Research Site | Rochester | New York |
| United States | Research Site | Rolling Hills Estates | California |
| United States | Research Site | Saginaw | Michigan |
| United States | Research Site | San Antonio | Texas |
| United States | Research Site | San Diego | California |
| United States | Research Site | Savannah | Georgia |
| United States | Research Site | Shreveport | Louisiana |
| United States | Research Site | Simpsonville | South Carolina |
| United States | Research Site | South Bend | Indiana |
| United States | Research Site | South Miami | Florida |
| United States | Research Site | Southfield | Michigan |
| United States | Research Site | Spartanburg | South Carolina |
| United States | Research Site | Springfield | Virginia |
| United States | Research Site | Stockton | California |
| United States | Research Site | Stone Mountain | Georgia |
| United States | Research Site | Sugar Land | Texas |
| United States | Research Site | Sugarland | Texas |
| United States | Research Site | Sunset | Louisiana |
| United States | Research Site | Tampa | Florida |
| United States | Research Site | Teaneck | New Jersey |
| United States | Research Site | Toledo | Ohio |
| United States | Research Site | Tonawanda | New York |
| United States | Research Site | Topeka | Kansas |
| United States | Research Site | Torrance | California |
| United States | Research Site | Union | South Carolina |
| United States | Research Site | Upland | Pennsylvania |
| United States | Research Site | Verona | New Jersey |
| United States | Research Site | Vicksburg | Mississippi |
| United States | Research Site | Waco | Texas |
| United States | Research Site | Washington | District of Columbia |
| United States | Research Site | West Palm Beach | Florida |
| United States | Research Site | Wheaton | Maryland |
| United States | Research Site | Wichita | Kansas |
| United States | Research Site | Winnetka | California |
| United States | Research Site | Winston-Salem | North Carolina |
| United States | Research Site | Yardley | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | 52 Weeks | No |
| Secondary | Asthma Exacerbations | Number of participants with at least 1 exacerbation | 52 Weeks | No |
| Secondary | 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 | Baseline and 52 weeks | No |
| Secondary | 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. | Baseline and 2 weeks (visit 4) | No |
| Secondary | 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. | Baseline and 2 weeks (visit 4) | No |
| Secondary | 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. | Baseline and 2 weeks (visit 4) | No |
| Secondary | 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 | baseline and 52 weeks | No |
| Secondary | 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 | baseline and 52 weeks | No |
| Secondary | 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 | baseline and 52 weeks | No |
| Secondary | 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" | 1 week | No |
| Secondary | 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" | 1 week | No |
| Secondary | 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. | baseline and 52 weeks | No |
| Secondary | 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 | baseline and 52 weeks | No |
| Secondary | 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. | Baseline and 52 weeks | No |
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