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)
Overview
- Phase
- Phase 3
- Intervention
- Symbicort Turbuhaler (Budesonide/formoterol)
- Conditions
- Chronic Obstructive Pulmonary Disease
- Sponsor
- AstraZeneca
- Enrollment
- 328
- Locations
- 1
- Primary Endpoint
- Clinical Laboratory Test: Haematology -Haemoglobin
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
Eligibility 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.
Arms & Interventions
1
Intervention: Symbicort Turbuhaler (Budesonide/formoterol)
Outcomes
Primary Outcomes
Clinical Laboratory Test: Haematology -Haemoglobin
Time Frame: Baseline and 52 week after
Change from baseline
Clinical Laboratory Test: Haematology -Leucocytes
Time Frame: Baseline and 52 week after
Change from baseline
Clinical Laboratory Test: Haematology -Platelet Count
Time Frame: Baseline and 52 week after
Change from baseline
Clinical Laboratory Test: Haematology -Eosinophils
Time Frame: Baseline and 52 week after
Change from baseline
Clinical Laboratory Test: Haematology -Basophils
Time Frame: Baseline and 52 week after
Change from baseline
Clinical Laboratory Test: Haematology -Lymphocytes
Time Frame: Baseline and 52 week after
Change from baseline
Clinical Laboratory Test: Haematology -Monocytes
Time Frame: Baseline and 52 week after
Change from baseline
Clinical Laboratory Test: Haematology -Neutrophils
Time Frame: Baseline and 52 week after
Change from baseline
Clinical Laboratory Test: Clinical Chemistry- S-Alanine Aminotransferase
Time Frame: Baseline and 52 week after
Change from baseline
Clinical Laboratory Test: Haematology -Erythrocytes
Time Frame: Baseline and 52 week after
Mean change from Baseline
Clinical Laboratory Test: Clinical Chemistry- S-Aspartate Aminotransferase
Time Frame: Baseline and 52 week after
Change from baseline
Clinical Laboratory Test: Clinical Chemistry- S-Alkaline Phosphatase (ALP)
Time Frame: Baseline and 52 week after
Change from baseline
Clinical Laboratory Test: Clinical Chemistry- S-Creatinine
Time Frame: Baseline and 52 week after
Change from baseline
Clinical Laboratory Test: Clinical Chemistry- S-Total Bilirubin
Time Frame: Baseline and 52 week after
Change from baseline
Clinical Laboratory Test: Clinical Chemistry- S-Sodium
Time Frame: Baseline and 52 week after
Change from baseline
Clinical Laboratory Test: Clinical Chemistry- S-Potassium
Time Frame: Baseline and 52 week after
Change from baseline
Clinical Laboratory Test: Clinical Chemistry- S- Calcium
Time Frame: Baseline and 52 week after
Change from baseline
Clinical Laboratory Test: Clinical Chemistry- S-Albumin
Time Frame: Baseline and 52 week after
Change from baseline
Clinical Laboratory Test: Clinical Chemistry- S-Protein, Total
Time Frame: Baseline and 52 week after
Change from baseline
Clinical Laboratory Test: Clinical Chemistry- S-C-Reactive Protein
Time Frame: Baseline and 52 week after
Change from baseline
Clinical Laboratory Test: Clinical Chemistry- S-Urea Nitrogen
Time Frame: Baseline and 52 week after
Change from baseline
Vital Signs- Sitting Systolic Blood Pressure(SBP)
Time Frame: Baseline and 52 week after
Change from baseline
Vital Signs- Sitting Diastolic Blood Pressure(DBP)
Time Frame: Baseline and 52 week after
Change from baseline
Vital Signs- Pulse Rate
Time Frame: Baseline and 52 week after
Change from baseline
ECG Variables - Heart Rate
Time Frame: Baseline and 52 week after
Change from baseline
ECG Variables - QT Interval
Time Frame: Baseline and 52 week after
Change from baseline
ECG Variables - QTcB Interval
Time Frame: Baseline and 52 week after
Change from baseline
ECG Variables - QTcF Interval
Time Frame: Baseline and 52 week after
Change from baseline
ECG Variables - RR Interval
Time Frame: Baseline and 52 week after
Change from baseline
Secondary Outcomes
- Chronic Obstructive Pulmonary Disease (COPD) symptoms_Night-time Awakening(Daily during run-in period and daily during 52-week randomization treatment)
- Chronic Obstructive Pulmonary Disease (COPD) symptoms_Breathlessness(Daily during run-in period and daily during 52-week randomization treatment)
- Chronic Obstructive Pulmonary Disease (COPD) symptoms_cough(Daily during run-in period and daily during 52-week randomization treatment)
- 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)
- 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)
- Time to First COPD Exacerbation(Daily during 52-week randomization treatment)
- Number of COPD Exacerbations Over the Study Treatment Period(Daily during 52-week randomization treatment)
- Rescue Medication Use(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)
- Morning Peak Expiratory Flow (PEF) Measured at Home(Daily during run-in period and daily 52-week randomization treatment)
- Evening Peak Expiratory Flow (PEF) Measured at Home(Daily during run-in period and daily 52-week randomization treatment)
- Morning FEV1 Measured by the Subjects at Home(Daily during run-in period and daily 52-week randomization treatment)
- Evening FEV1 Measured by the Subjects at Home(Daily during run-in period and daily 52-week randomization treatment)