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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00419952
First received: January 5, 2007
Last updated: September 28, 2012
Last verified: September 2012
  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
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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
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
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 August 28, 2014