A Comparison of SYMBICORT® pMDI With Budesonide HFA pMDI in African American Subjects With Asthma.
This study has been completed.
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00419952
First received: January 5, 2007
Last updated: September 28, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: Budesonide/formoterol (SYMBICORT) pMDI Drug: Budesonide HFA pMDI |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Total Number of Asthma Exacerbations [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]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:
- Asthma Exacerbations [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]Number of participants with at least 1 exacerbation
- QT Interval Corrected Using the Fridericia Formula Measured Via Electrocardiogram (ECG) [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline and 2 weeks (visit 4) ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline and 2 weeks (visit 4) ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline and 2 weeks (visit 4) ] [ Designated as safety issue: No ]Total ventricular runs - number of participants with shift normal (<1) to high (≥1) from baseline to week 2.
- Diary Assessments - Rescue-free Day [ Time Frame: baseline and 52 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: baseline and 52 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: baseline and 52 weeks ] [ Designated as safety issue: No ]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) [ Time Frame: 1 week ] [ Designated as safety issue: No ]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"
- Onset of Effect Questionnaire (OEQ) [ Time Frame: 1 week ] [ Designated as safety issue: No ]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 [ Time Frame: baseline and 52 weeks ] [ Designated as safety issue: No ]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) [ Time Frame: baseline and 52 weeks ] [ Designated as safety issue: No ]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) [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]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.
| Enrollment: | 742 |
| Study Start Date: | February 2007 |
| Study Completion Date: | November 2009 |
| Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00419952
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Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | Christer Hultquist, MD | AstraZeneca |
More Information
Additional Information:
No publications provided
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00419952 History of Changes |
| Other Study ID Numbers: | D5896C00022 |
| Study First Received: | January 5, 2007 |
| Results First Received: | November 30, 2010 |
| Last Updated: | September 28, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by AstraZeneca:
|
Moderate Asthma Severe Asthma |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Budesonide Formoterol Symbicort Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Inflammatory Agents Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 22, 2013