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

Phase 3

Completed

• Conditions: Asthma
• Interventions: Drug: Budesonide/formoterol (SYMBICORT) pMDI; Drug: Budesonide HFA pMDI

• Registration Number: NCT00419952
• Lead Sponsor: AstraZeneca

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2007-01-05
• Study First Submitted QC: 2007-01-05
• Study First Posted: 2007-01-09
• Study Start: 2007-02
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Results First Submitted: 2010-11-30
• Status Verified: 2012-09
• Results First Submitted QC: 2012-09-28
• Last Update Submitted: 2012-09-28
• Results First Posted: 2012-10-30
• Last Update Posted: 2012-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 742

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Total Number of Asthma Exacerbations	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.

Secondary Outcome Measures

Name	Time	Method
Asthma Exacerbations	52 Weeks	Number of participants with at least 1 exacerbation
QT Interval Corrected Using the Fridericia Formula Measured Via Electrocardiogram (ECG)	Baseline and 52 weeks	QT interval corrected using the Fridericia formula \[QTc (Frid)\] - Change from baseline to end of treatment
Number of Patients With Shift From Normal to High Rate of Total Ectopic Ventricular Beats as Measured by 24-hour Holter Monitor Assessment	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.
Number of Patients With Shift From Normal to High Rate of Total Ectopic Supraventricular Beats as Measured by 24-hour Holter Monitor Assessment	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.
Total Number of Ventricular Runs as Measured by 24-hour Holter Monitor Assessment	Baseline and 2 weeks (visit 4)	Total ventricular runs - number of participants with shift normal (\<1) to high (≥1) from baseline to week 2.
Diary Assessments - Rescue-free Day	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
Diary Assessments - Symptom-free Day	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
Diary Assessments - Asthma-control Day	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
Onset of Effect Questionnaire (OEQ)	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"
Peak Expiratory Flow (PEF) in Morning	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.
Forced Expiratory Volume in One Second (FEV1)	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
Asthma Treatment Satisfaction Measure (ATSM)	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.

Trial Locations

Locations (1)

Research Site; 🇺🇸 Springfield, Virginia, United States