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

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)

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: Symbicort Turbuhaler (Budesonide/formoterol); Drug: Drug: any available COPD treatment; investigator to decide

• Study Type: Interventional
• Enrollment (Actual): 328
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Hiroshima, Japan
    • Research Site
  • Kyoto, Japan
    • Research Site
  • Aichi
    • Nagoya, Aichi, Japan
      • Research Site
    • Toyota, Aichi, Japan
      • Research Site
  • Fukuoka
    • Yanagawa, Fukuoka, Japan
      • Research Site
  • Hokkaido
    • Asahikawa, Hokkaido, Japan
      • Research Site
    • Sapporo, Hokkaido, Japan
      • Research Site
  • Hyogo
    • Itami, Hyogo, Japan
      • Research Site
  • Ibaraki
    • Hitachi, Ibaraki, Japan
      • Research Site
    • Tsukuba, Ibaraki, Japan
      • Research Site
  • Kagawa
    • Sakaide, Kagawa, Japan
      • Research Site
  • Kanagawa
    • Fujisawa, Kanagawa, Japan
      • Research Site
    • Yokohama, Kanagawa, Japan
      • Research Site
  • Kumamoto
    • Koshi, Kumamoto, Japan
      • Research Site
  • Miyagi
    • Shibata, Miyagi, Japan
      • Research Site
  • Tokyo
    • Chuo, Tokyo, Japan
      • Research Site
    • Setagaya, Tokyo, Japan
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: Symbicort Turbuhaler (Budesonide/formoterol); 2 x 160/4.5 microgram, inhalation, bid, 52 weeks; Other Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Laboratory Test: Haematology -Erythrocytes	Mean change from Baseline	Baseline and 52 week after
Clinical Laboratory Test: Haematology -Haemoglobin	Change from baseline	Baseline and 52 week after
Clinical Laboratory Test: Haematology -Leucocytes	Change from baseline	Baseline and 52 week after
Clinical Laboratory Test: Haematology -Platelet Count	Change from baseline	Baseline and 52 week after
Clinical Laboratory Test: Haematology -Eosinophils	Change from baseline	Baseline and 52 week after
Clinical Laboratory Test: Haematology -Basophils	Change from baseline	Baseline and 52 week after
Clinical Laboratory Test: Haematology -Lymphocytes	Change from baseline	Baseline and 52 week after
Clinical Laboratory Test: Haematology -Monocytes	Change from baseline	Baseline and 52 week after
Clinical Laboratory Test: Haematology -Neutrophils	Change from baseline	Baseline and 52 week after
Clinical Laboratory Test: Clinical Chemistry- S-Alanine Aminotransferase	Change from baseline	Baseline and 52 week after
Clinical Laboratory Test: Clinical Chemistry- S-Aspartate Aminotransferase	Change from baseline	Baseline and 52 week after
Clinical Laboratory Test: Clinical Chemistry- S-Alkaline Phosphatase (ALP)	Change from baseline	Baseline and 52 week after
Clinical Laboratory Test: Clinical Chemistry- S-Creatinine	Change from baseline	Baseline and 52 week after
Clinical Laboratory Test: Clinical Chemistry- S-Total Bilirubin	Change from baseline	Baseline and 52 week after
Clinical Laboratory Test: Clinical Chemistry- S-Sodium	Change from baseline	Baseline and 52 week after
Clinical Laboratory Test: Clinical Chemistry- S-Potassium	Change from baseline	Baseline and 52 week after
Clinical Laboratory Test: Clinical Chemistry- S- Calcium	Change from baseline	Baseline and 52 week after
Clinical Laboratory Test: Clinical Chemistry- S-Albumin	Change from baseline	Baseline and 52 week after
Clinical Laboratory Test: Clinical Chemistry- S-Protein, Total	Change from baseline	Baseline and 52 week after
Clinical Laboratory Test: Clinical Chemistry- S-C-Reactive Protein	Change from baseline	Baseline and 52 week after
Clinical Laboratory Test: Clinical Chemistry- S-Urea Nitrogen	Change from baseline	Baseline and 52 week after
Vital Signs- Sitting Systolic Blood Pressure(SBP)	Change from baseline	Baseline and 52 week after
Vital Signs- Sitting Diastolic Blood Pressure(DBP)	Change from baseline	Baseline and 52 week after
Vital Signs- Pulse Rate	Change from baseline	Baseline and 52 week after
ECG Variables - Heart Rate	Change from baseline	Baseline and 52 week after
ECG Variables - QT Interval	Change from baseline	Baseline and 52 week after
ECG Variables - QTcB Interval	Change from baseline	Baseline and 52 week after
ECG Variables - QTcF Interval	Change from baseline	Baseline and 52 week after
ECG Variables - RR Interval	Change from baseline	Baseline and 52 week after

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chronic Obstructive Pulmonary Disease (COPD) symptoms_Night-time Awakening	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	Daily during run-in period and daily during 52-week randomization treatment
Chronic Obstructive Pulmonary Disease (COPD) symptoms_Breathlessness	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	Daily during run-in period and daily during 52-week randomization treatment
Chronic Obstructive Pulmonary Disease (COPD) symptoms_cough	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	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	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.	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	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.	Before randomization, 0, 4, 8, 17, 26, 34, 43 and 52 weeks after randomization
Time to First COPD Exacerbation	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.	Daily during 52-week randomization treatment
Number of COPD Exacerbations Over the Study Treatment Period	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	Daily during 52-week randomization treatment
Rescue Medication Use	The change from run-in period and daily during 52-week randomization treatment	Daily during 52-week randomization treatment
Health Related Quality of Life (HRQL) Based on the St. George's Respiratory Questionnaire (SGRQ)	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).	Daily during run-in period and daily 52-week randomization treatment
Morning Peak Expiratory Flow (PEF) Measured at Home	The change from Run-in period average to 52-week randomization Treatment period average for each treatment group	Daily during run-in period and daily 52-week randomization treatment
Evening Peak Expiratory Flow (PEF) Measured at Home	The change from Run-in period average to 52-week randomization Treatment period average for each treatment group	Daily during run-in period and daily 52-week randomization treatment
Morning FEV1 Measured by the Subjects at Home	The change from run-in period and daily during 52-week randomization treatment	Daily during run-in period and daily 52-week randomization treatment
Evening FEV1 Measured by the Subjects at Home	The change from run-in period and daily during 52-week randomization treatment	Daily during run-in period and daily 52-week randomization treatment

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Chair: Tomas Andersson, MD, AstraZeneca, R&D, Lund, Sweden

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: February 11, 2010
• First Submitted That Met QC Criteria: February 17, 2010
• First Posted (Estimate): February 18, 2010

Study Record Updates

• Last Update Posted (Estimate): April 29, 2014
• Last Update Submitted That Met QC Criteria: April 14, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Safety; COPD; Efficacy; Japanese; Symbicort
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Budesonide; Formoterol Fumarate; Budesonide, Formoterol Fumarate Drug Combination
• Other Study ID Numbers: D589DC00008