A Safety and Efficacy Study of Symbicort Turbuhaler Compared With Standard Chronic Obstructive Pulmonary Disease (COPD) Treatment in Japan
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Registration Number
- NCT01070784
- Lead Sponsor
- AstraZeneca
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 328
- 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%
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Symbicort Turbuhaler (Budesonide/formoterol) -
- Primary Outcome Measures
Name Time Method Clinical Laboratory Test: Haematology -Haemoglobin Baseline and 52 week after Change from baseline
ECG Variables - QTcB Interval Baseline and 52 week after Change from baseline
Clinical Laboratory Test: Haematology -Leucocytes Baseline and 52 week after Change from baseline
Clinical Laboratory Test: Haematology -Platelet Count Baseline and 52 week after Change from baseline
Clinical Laboratory Test: Haematology -Eosinophils Baseline and 52 week after Change from baseline
Clinical Laboratory Test: Haematology -Basophils Baseline and 52 week after Change from baseline
Clinical Laboratory Test: Haematology -Lymphocytes Baseline and 52 week after Change from baseline
Clinical Laboratory Test: Haematology -Monocytes Baseline and 52 week after Change from baseline
Clinical Laboratory Test: Haematology -Neutrophils Baseline and 52 week after Change from baseline
Clinical Laboratory Test: Clinical Chemistry- S-Alanine Aminotransferase Baseline and 52 week after Change from baseline
Clinical Laboratory Test: Haematology -Erythrocytes Baseline and 52 week after Mean change from Baseline
Clinical Laboratory Test: Clinical Chemistry- S-Aspartate Aminotransferase Baseline and 52 week after Change from baseline
Clinical Laboratory Test: Clinical Chemistry- S-Alkaline Phosphatase (ALP) Baseline and 52 week after Change from baseline
Clinical Laboratory Test: Clinical Chemistry- S-Creatinine Baseline and 52 week after Change from baseline
Clinical Laboratory Test: Clinical Chemistry- S-Total Bilirubin Baseline and 52 week after Change from baseline
Clinical Laboratory Test: Clinical Chemistry- S-Sodium Baseline and 52 week after Change from baseline
Clinical Laboratory Test: Clinical Chemistry- S-Potassium Baseline and 52 week after Change from baseline
ECG Variables - QT Interval Baseline and 52 week after Change from baseline
Clinical Laboratory Test: Clinical Chemistry- S- Calcium Baseline and 52 week after Change from baseline
Clinical Laboratory Test: Clinical Chemistry- S-Albumin Baseline and 52 week after Change from baseline
Clinical Laboratory Test: Clinical Chemistry- S-Protein, Total Baseline and 52 week after Change from baseline
Clinical Laboratory Test: Clinical Chemistry- S-C-Reactive Protein Baseline and 52 week after Change from baseline
Clinical Laboratory Test: Clinical Chemistry- S-Urea Nitrogen Baseline and 52 week after Change from baseline
Vital Signs- Sitting Systolic Blood Pressure(SBP) Baseline and 52 week after Change from baseline
Vital Signs- Sitting Diastolic Blood Pressure(DBP) Baseline and 52 week after Change from baseline
Vital Signs- Pulse Rate Baseline and 52 week after Change from baseline
ECG Variables - Heart Rate Baseline and 52 week after Change from baseline
ECG Variables - QTcF Interval Baseline and 52 week after Change from baseline
ECG Variables - RR Interval Baseline and 52 week after Change from baseline
- Secondary Outcome Measures
Name Time Method Chronic Obstructive Pulmonary Disease (COPD) symptoms_Night-time Awakening 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
Chronic Obstructive Pulmonary Disease (COPD) symptoms_Breathlessness 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
Chronic Obstructive Pulmonary Disease (COPD) symptoms_cough 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
Forced Expiratory Volume in 1 Second (FEV1) Measured With the Spirometer at the Clinic 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.
Forced Vital Capacity (FVC) Measured With the Spirometer at the Clinic 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.
Time to First COPD Exacerbation 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.
Number of COPD Exacerbations Over the Study Treatment Period 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
Rescue Medication Use Daily during 52-week randomization treatment The change from run-in period and daily during 52-week randomization treatment
Health Related Quality of Life (HRQL) Based on the St. George's Respiratory Questionnaire (SGRQ) 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).
Morning Peak Expiratory Flow (PEF) Measured at Home 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
Evening Peak Expiratory Flow (PEF) Measured at Home 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
Morning FEV1 Measured by the Subjects at Home Daily during run-in period and daily 52-week randomization treatment The change from run-in period and daily during 52-week randomization treatment
Evening FEV1 Measured by the Subjects at Home Daily during run-in period and daily 52-week randomization treatment The change from run-in period and daily during 52-week randomization treatment
Trial Locations
- Locations (1)
Research Site
🇯🇵Kyoto, Japan