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A Safety and Efficacy Study of Symbicort Turbuhaler Compared With Standard Chronic Obstructive Pulmonary Disease (COPD) Treatment in Japan

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ClinicalTrials.gov Identifier: NCT01070784
Recruitment Status : Completed
First Posted : February 18, 2010
Results First Posted : December 5, 2013
Last Update Posted : April 29, 2014
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of Symbicort Turbuhaler compared to standard COPD treatment during one year in Japanese patients with COPD.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: Symbicort Turbuhaler (Budesonide/formoterol) Drug: Drug: any available COPD treatment; investigator to decide Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 328 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Phase III, Multi-centre 52-week , Parallel-group Study Evaluating the Safety and Efficacy of Symbicort Turbuhaler 320/9 Twice Daily Compared With Standard Treatment in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study Start Date : January 2010
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 Drug: Symbicort Turbuhaler (Budesonide/formoterol)
2 x 160/4.5 microgram, inhalation, bid, 52 weeks
Other Name: Symbicort Turbuhaler
Active Comparator: 2 Drug: Drug: any available COPD treatment; investigator to decide
According to investigator decision, 52 weeks, Standard COPD treatment according to investigator decision


Outcome Measures
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Primary Outcome Measures :
  1. Clinical Laboratory Test: Haematology -Erythrocytes [ Time Frame: Baseline and 52 week after ]
    Mean change from Baseline

  2. Clinical Laboratory Test: Haematology -Haemoglobin [ Time Frame: Baseline and 52 week after ]
    Change from baseline

  3. Clinical Laboratory Test: Haematology -Leucocytes [ Time Frame: Baseline and 52 week after ]
    Change from baseline

  4. Clinical Laboratory Test: Haematology -Platelet Count [ Time Frame: Baseline and 52 week after ]
    Change from baseline

  5. Clinical Laboratory Test: Haematology -Eosinophils [ Time Frame: Baseline and 52 week after ]
    Change from baseline

  6. Clinical Laboratory Test: Haematology -Basophils [ Time Frame: Baseline and 52 week after ]
    Change from baseline

  7. Clinical Laboratory Test: Haematology -Lymphocytes [ Time Frame: Baseline and 52 week after ]
    Change from baseline

  8. Clinical Laboratory Test: Haematology -Monocytes [ Time Frame: Baseline and 52 week after ]
    Change from baseline

  9. Clinical Laboratory Test: Haematology -Neutrophils [ Time Frame: Baseline and 52 week after ]
    Change from baseline

  10. Clinical Laboratory Test: Clinical Chemistry- S-Alanine Aminotransferase [ Time Frame: Baseline and 52 week after ]
    Change from baseline

  11. Clinical Laboratory Test: Clinical Chemistry- S-Aspartate Aminotransferase [ Time Frame: Baseline and 52 week after ]
    Change from baseline

  12. Clinical Laboratory Test: Clinical Chemistry- S-Alkaline Phosphatase (ALP) [ Time Frame: Baseline and 52 week after ]
    Change from baseline

  13. Clinical Laboratory Test: Clinical Chemistry- S-Creatinine [ Time Frame: Baseline and 52 week after ]
    Change from baseline

  14. Clinical Laboratory Test: Clinical Chemistry- S-Total Bilirubin [ Time Frame: Baseline and 52 week after ]
    Change from baseline

  15. Clinical Laboratory Test: Clinical Chemistry- S-Sodium [ Time Frame: Baseline and 52 week after ]
    Change from baseline

  16. Clinical Laboratory Test: Clinical Chemistry- S-Potassium [ Time Frame: Baseline and 52 week after ]
    Change from baseline

  17. Clinical Laboratory Test: Clinical Chemistry- S- Calcium [ Time Frame: Baseline and 52 week after ]
    Change from baseline

  18. Clinical Laboratory Test: Clinical Chemistry- S-Albumin [ Time Frame: Baseline and 52 week after ]
    Change from baseline

  19. Clinical Laboratory Test: Clinical Chemistry- S-Protein, Total [ Time Frame: Baseline and 52 week after ]
    Change from baseline

  20. Clinical Laboratory Test: Clinical Chemistry- S-C-Reactive Protein [ Time Frame: Baseline and 52 week after ]
    Change from baseline

  21. Clinical Laboratory Test: Clinical Chemistry- S-Urea Nitrogen [ Time Frame: Baseline and 52 week after ]
    Change from baseline

  22. Vital Signs- Sitting Systolic Blood Pressure(SBP) [ Time Frame: Baseline and 52 week after ]
    Change from baseline

  23. Vital Signs- Sitting Diastolic Blood Pressure(DBP) [ Time Frame: Baseline and 52 week after ]
    Change from baseline

  24. Vital Signs- Pulse Rate [ Time Frame: Baseline and 52 week after ]
    Change from baseline

  25. ECG Variables - Heart Rate [ Time Frame: Baseline and 52 week after ]
    Change from baseline

  26. ECG Variables - QT Interval [ Time Frame: Baseline and 52 week after ]
    Change from baseline

  27. ECG Variables - QTcB Interval [ Time Frame: Baseline and 52 week after ]
    Change from baseline

  28. ECG Variables - QTcF Interval [ Time Frame: Baseline and 52 week after ]
    Change from baseline

  29. ECG Variables - RR Interval [ Time Frame: Baseline and 52 week after ]
    Change from baseline


Secondary Outcome Measures :
  1. Chronic Obstructive Pulmonary Disease (COPD) symptoms_Night-time Awakening [ Time Frame: Daily during run-in period and daily during 52-week randomization treatment ]
    There are 5 alternatives (scored 0 to 4, 0= no awakening and 4 =did not sleep at all). The change from Run-in period average to Treatment period average for each treatment group

  2. Chronic Obstructive Pulmonary Disease (COPD) symptoms_Breathlessness [ Time Frame: Daily during run-in period and daily during 52-week randomization treatment ]
    There are 5 alternatives (scored 0 to 4, 0= unaware of any difficulty and 4 =almost constant, present even when resting). The change from Run-in period average to Treatment period average for each treatment group

  3. Chronic Obstructive Pulmonary Disease (COPD) symptoms_cough [ Time Frame: Daily during run-in period and daily during 52-week randomization treatment ]
    There are 5 alternatives (scored 0 to 4, 0= unaware of coughing, 4= never free of cough or need to cough). The change from Run-in period average to Treatment period average for each treatment group

  4. Forced Expiratory Volume in 1 Second (FEV1) Measured With the Spirometer at the Clinic [ Time Frame: Before randomization, 0, 4, 8, 17, 26, 34, 43 and 52 weeks after randomization ]
    The ratio of the average value of available data for Weeks 0, 4, 8, 17, 26, 34, 43 and 52 to the baseline for each treatment group. Ratio is being reported as a percentage in this Measure.

  5. Forced Vital Capacity (FVC) Measured With the Spirometer at the Clinic [ Time Frame: Before randomization, 0, 4, 8, 17, 26, 34, 43 and 52 weeks after randomization ]
    The ratio of the average value of available data for Weeks 0, 4, 8, 17, 26, 34, 43 and 52 to the baseline for each treatment group. Ratio is being reported as a percentage in this Measure.

  6. Time to First COPD Exacerbation [ Time Frame: Daily during 52-week randomization treatment ]
    A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as worsening in COPD symptoms requiring treatment with either a course of systemic steroid or hospitalisation. The percentage of participants who had experienced COPD exacerbation at the end of the study for each treatment group.

  7. Number of COPD Exacerbations Over the Study Treatment Period [ Time Frame: Daily during 52-week randomization treatment ]
    A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as worsening in COPD symptoms requiring treatment with either a course of systemic steroid or hospitalisation. Number of COPD exacerbation during 52-week randomization treatment

  8. Rescue Medication Use [ Time Frame: Daily during 52-week randomization treatment ]
    The change from run-in period and daily during 52-week randomization treatment

  9. Health Related Quality of Life (HRQL) Based on the St. George's Respiratory Questionnaire (SGRQ) [ Time Frame: Daily during run-in period and daily 52-week randomization treatment ]
    The change from run-in period and daily during 52-week randomization treatment average for each treatment group. The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life).

  10. Morning Peak Expiratory Flow (PEF) Measured at Home [ Time Frame: Daily during run-in period and daily 52-week randomization treatment ]
    The change from Run-in period average to 52-week randomization Treatment period average for each treatment group

  11. Evening Peak Expiratory Flow (PEF) Measured at Home [ Time Frame: Daily during run-in period and daily 52-week randomization treatment ]
    The change from Run-in period average to 52-week randomization Treatment period average for each treatment group

  12. Morning FEV1 Measured by the Subjects at Home [ Time Frame: Daily during run-in period and daily 52-week randomization treatment ]
    The change from run-in period and daily during 52-week randomization treatment

  13. Evening FEV1 Measured by the Subjects at Home [ Time Frame: Daily during run-in period and daily 52-week randomization treatment ]
    The change from run-in period and daily during 52-week randomization treatment


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A current clinical diagnosis of COPD according to the guidelines (GOLD, JPS)
  • Documented COPD symptoms for more than 2 years
  • Pre-bronchodilator FEV1≦50% of predicted normal value, and post-bronchodilator FEV1/FVC<70%

Exclusion Criteria:

  • History and/or current clinical diagnosis of asthma and atopic diseases such as allergic rhinitis
  • Subjects with significant or unstable ischemic heart disease, arrhythmia, cardiomyopathy, heart failure, uncontrolled hypertension as defined by the investigator, or any other relevant cardiovascular disorder as judged by the investigator
  • COPD exacerbation during the run-in period or within 4 weeks prior to registration, requiring hospitalization and/or treatment with systemic steroids.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01070784


Locations
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Japan
Research Site
Nagoya, Aichi, Japan
Research Site
Toyota, Aichi, Japan
Research Site
Yanagawa, Fukuoka, Japan
Research Site
Asahikawa, Hokkaido, Japan
Research Site
Sapporo, Hokkaido, Japan
Research Site
Itami, Hyogo, Japan
Research Site
Hitachi, Ibaraki, Japan
Research Site
Tsukuba, Ibaraki, Japan
Research Site
Sakaide, Kagawa, Japan
Research Site
Fujisawa, Kanagawa, Japan
Research Site
Yokohama, Kanagawa, Japan
Research Site
Koshi, Kumamoto, Japan
Research Site
Shibata, Miyagi, Japan
Research Site
Chuo, Tokyo, Japan
Research Site
Setagaya, Tokyo, Japan
Research Site
Hiroshima, Japan
Research Site
Kyoto, Japan
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Chair: Tomas Andersson, MD AstraZeneca, R&D, Lund, Sweden
More Information
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Additional Information:

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01070784    
Other Study ID Numbers: D589DC00008
First Posted: February 18, 2010    Key Record Dates
Results First Posted: December 5, 2013
Last Update Posted: April 29, 2014
Last Verified: April 2014
Keywords provided by AstraZeneca:
Symbicort
Safety
Efficacy
COPD
Japanese
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Budesonide
Formoterol Fumarate
Budesonide, Formoterol Fumarate Drug Combination
Anti-Inflammatory Agents
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