A Safety and Efficacy Study of Symbicort Turbuhaler Compared With Standard Chronic Obstructive Pulmonary Disease (COPD) Treatment in Japan
Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Obstructive Pulmonary Disease
Intervention: Symbicort Turbuhaler (Budesonide/formoterol) (Drug); Drug: any available COPD treatment; investigator to decide (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s): Tomas Andersson, MD, Study Chair, Affiliation: AstraZeneca, R&D, Lund, Sweden
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Clinical Laboratory Test: Haematology -ErythrocytesClinical Laboratory Test: Haematology -Haemoglobin Clinical Laboratory Test: Haematology -Leucocytes Clinical Laboratory Test: Haematology -Platelet Count Clinical Laboratory Test: Haematology -Eosinophils Clinical Laboratory Test: Haematology -Basophils Clinical Laboratory Test: Haematology -Lymphocytes Clinical Laboratory Test: Haematology -Monocytes Clinical Laboratory Test: Haematology -Neutrophils Clinical Laboratory Test: Clinical Chemistry- S-Alanine Aminotransferase Clinical Laboratory Test: Clinical Chemistry- S-Aspartate Aminotransferase Clinical Laboratory Test: Clinical Chemistry- S-Alkaline Phosphatase (ALP) Clinical Laboratory Test: Clinical Chemistry- S-Creatinine Clinical Laboratory Test: Clinical Chemistry- S-Total Bilirubin Clinical Laboratory Test: Clinical Chemistry- S-Sodium Clinical Laboratory Test: Clinical Chemistry- S-Potassium Clinical Laboratory Test: Clinical Chemistry- S- Calcium Clinical Laboratory Test: Clinical Chemistry- S-Albumin Clinical Laboratory Test: Clinical Chemistry- S-Protein, Total Clinical Laboratory Test: Clinical Chemistry- S-C-Reactive Protein Clinical Laboratory Test: Clinical Chemistry- S-Urea Nitrogen Vital Signs- Sitting Systolic Blood Pressure(SBP) Vital Signs- Sitting Diastolic Blood Pressure(DBP) Vital Signs- Pulse Rate ECG Variables - Heart Rate ECG Variables - QT Interval ECG Variables - QTcB Interval ECG Variables - QTcF Interval ECG Variables - RR Interval
Secondary outcome: Chronic Obstructive Pulmonary Disease (COPD) symptoms_Night-time AwakeningChronic Obstructive Pulmonary Disease (COPD) symptoms_Breathlessness Chronic Obstructive Pulmonary Disease (COPD) symptoms_cough Forced Expiratory Volume in 1 Second (FEV1) Measured With the Spirometer at the Clinic Forced Vital Capacity (FVC) Measured With the Spirometer at the Clinic Time to First COPD Exacerbation Number of COPD Exacerbations Over the Study Treatment Period Rescue Medication Use Health Related Quality of Life (HRQL) Based on the St. George's Respiratory Questionnaire (SGRQ) Morning Peak Expiratory Flow (PEF) Measured at Home Evening Peak Expiratory Flow (PEF) Measured at Home Morning FEV1 Measured by the Subjects at Home Evening FEV1 Measured by the Subjects at Home
Eligibility
Minimum age: 40 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Research Site, Hiroshima, Japan
Research Site, Kyoto, 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
Additional Information
Starting date: January 2010
Last updated: April 14, 2014
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