Clinical trial NCT01070784: A Safety and Efficacy Study of Symbicort Turbuhaler Compared With Standard Chronic Obstructive Pulmonary Disease (COPD) Treatment in Japan
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Symbicort
Safety
Efficacy
COPD
Japanese
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-02-18
Enrollment: 328
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Clinical Laboratory Test: Haematology -Erythrocytes
timeFrame: Baseline and 52 week after
measure: Clinical Laboratory Test: Haematology -Haemoglobin
timeFrame: Baseline and 52 week after
measure: Clinical Laboratory Test: Haematology -Leucocytes
timeFrame: Baseline and 52 week after
measure: Clinical Laboratory Test: Haematology -Platelet Count
timeFrame: Baseline and 52 week after
measure: Clinical Laboratory Test: Haematology -Eosinophils
timeFrame: Baseline and 52 week after
measure: Clinical Laboratory Test: Haematology -Basophils
timeFrame: Baseline and 52 week after
measure: Clinical Laboratory Test: Haematology -Lymphocytes
timeFrame: Baseline and 52 week after
measure: Clinical Laboratory Test: Haematology -Monocytes
timeFrame: Baseline and 52 week after
measure: Clinical Laboratory Test: Haematology -Neutrophils
timeFrame: Baseline and 52 week after
measure: Clinical Laboratory Test: Clinical Chemistry- S-Alanine Aminotransferase
timeFrame: Baseline and 52 week after
measure: Clinical Laboratory Test: Clinical Chemistry- S-Aspartate Aminotransferase
timeFrame: Baseline and 52 week after
measure: Clinical Laboratory Test: Clinical Chemistry- S-Alkaline Phosphatase (ALP)
timeFrame: Baseline and 52 week after
measure: Clinical Laboratory Test: Clinical Chemistry- S-Creatinine
timeFrame: Baseline and 52 week after
measure: Clinical Laboratory Test: Clinical Chemistry- S-Total Bilirubin
timeFrame: Baseline and 52 week after
measure: Clinical Laboratory Test: Clinical Chemistry- S-Sodium
timeFrame: Baseline and 52 week after
measure: Clinical Laboratory Test: Clinical Chemistry- S-Potassium
timeFrame: Baseline and 52 week after
measure: Clinical Laboratory Test: Clinical Chemistry- S- Calcium
timeFrame: Baseline and 52 week after
measure: Clinical Laboratory Test: Clinical Chemistry- S-Albumin
timeFrame: Baseline and 52 week after
measure: Clinical Laboratory Test: Clinical Chemistry- S-Protein, Total
timeFrame: Baseline and 52 week after
measure: Clinical Laboratory Test: Clinical Chemistry- S-C-Reactive Protein
timeFrame: Baseline and 52 week after
measure: Clinical Laboratory Test: Clinical Chemistry- S-Urea Nitrogen
timeFrame: Baseline and 52 week after
measure: Vital Signs- Sitting Systolic Blood Pressure(SBP)
timeFrame: Baseline and 52 week after
measure: Vital Signs- Sitting Diastolic Blood Pressure(DBP)
timeFrame: Baseline and 52 week after
measure: Vital Signs- Pulse Rate
timeFrame: Baseline and 52 week after
measure: ECG Variables - Heart Rate
timeFrame: Baseline and 52 week after
measure: ECG Variables - QT Interval
timeFrame: Baseline and 52 week after
measure: ECG Variables - QTcB Interval
timeFrame: Baseline and 52 week after
measure: ECG Variables - QTcF Interval
timeFrame: Baseline and 52 week after
measure: ECG Variables - RR Interval
timeFrame: Baseline and 52 week after
Secondary outcomes:
measure: Chronic Obstructive Pulmonary Disease (COPD) symptoms_Night-time Awakening
timeFrame: Daily during run-in period and daily during 52-week randomization treatment
measure: Chronic Obstructive Pulmonary Disease (COPD) symptoms_Breathlessness
timeFrame: Daily during run-in period and daily during 52-week randomization treatment
measure: Chronic Obstructive Pulmonary Disease (COPD) symptoms_cough
timeFrame: Daily during run-in period and daily during 52-week randomization treatment
measure: Forced Expiratory Volume in 1 Second (FEV1) Measured With the Spirometer at the Clinic
timeFrame: Before randomization, 0, 4, 8, 17, 26, 34, 43 and 52 weeks after randomization
measure: Forced Vital Capacity (FVC) Measured With the Spirometer at the Clinic
timeFrame: Before randomization, 0, 4, 8, 17, 26, 34, 43 and 52 weeks after randomization
measure: Time to First COPD Exacerbation
timeFrame: Daily during 52-week randomization treatment
measure: Number of COPD Exacerbations Over the Study Treatment Period
timeFrame: Daily during 52-week randomization treatment
measure: Rescue Medication Use
timeFrame: Daily during 52-week randomization treatment
measure: Health Related Quality of Life (HRQL) Based on the St. George's Respiratory Questionnaire (SGRQ)
timeFrame: Daily during run-in period and daily 52-week randomization treatment
measure: Morning Peak Expiratory Flow (PEF) Measured at Home
timeFrame: Daily during run-in period and daily 52-week randomization treatment
measure: Evening Peak Expiratory Flow (PEF) Measured at Home
timeFrame: Daily during run-in period and daily 52-week randomization treatment
measure: Morning FEV1 Measured by the Subjects at Home
timeFrame: Daily during run-in period and daily 52-week randomization treatment
measure: Evening FEV1 Measured by the Subjects at Home
timeFrame: Daily during run-in period and daily 52-week randomization treatment
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Research Site
state: Aichi
city: Toyota
country: Japan
facility: Research Site
state: Aichi
city: Yanagawa
country: Japan
facility: Research Site
state: Fukuoka
city: Asahikawa
country: Japan
facility: Research Site
state: Hokkaido
city: Sapporo
country: Japan
facility: Research Site
state: Hokkaido
city: Itami
country: Japan
facility: Research Site
state: Hyogo
city: Hitachi
country: Japan
facility: Research Site
state: Ibaraki
city: Tsukuba
country: Japan
facility: Research Site
state: Ibaraki
city: Sakaide
country: Japan
facility: Research Site
state: Kagawa
city: Fujisawa
country: Japan
facility: Research Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Research Site
state: Kanagawa
city: Koshi
country: Japan
facility: Research Site
state: Kumamoto
city: Shibata
country: Japan
facility: Research Site
state: Miyagi
city: Chuo
country: Japan
facility: Research Site
state: Tokyo
city: Setagaya
country: Japan
facility: Research Site
state: Tokyo
city: Hiroshima
country: Japan
facility: Research Site
city: Kyoto
country: Japan
facility: Research Site
Study officials:
affiliation: AstraZeneca, R&D, Lund, Sweden
name: Tomas Andersson, MD
role: STUDY_CHAIR
References: