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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Symbicort Turbuhaler (Budesonide/formoterol)
Drug: any available COPD treatment; investigator to decide
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Symbicort, Safety, Efficacy, COPD, Japanese

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
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.
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.
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.
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
Rescue Medication Use
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)
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
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
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
The change from run-in period and daily during 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

Full Information

First Posted
February 11, 2010
Last Updated
April 14, 2014
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT01070784
Brief Title
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

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Symbicort, Safety, Efficacy, COPD, Japanese

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
328 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Symbicort Turbuhaler (Budesonide/formoterol)
Other Intervention Name(s)
Symbicort Turbuhaler
Intervention Description
2 x 160/4.5 microgram, inhalation, bid, 52 weeks
Intervention Type
Drug
Intervention Name(s)
Drug: any available COPD treatment; investigator to decide
Intervention Description
According to investigator decision, 52 weeks, Standard COPD treatment according to investigator decision
Primary Outcome Measure Information:
Title
Clinical Laboratory Test: Haematology -Erythrocytes
Description
Mean change from Baseline
Time Frame
Baseline and 52 week after
Title
Clinical Laboratory Test: Haematology -Haemoglobin
Description
Change from baseline
Time Frame
Baseline and 52 week after
Title
Clinical Laboratory Test: Haematology -Leucocytes
Description
Change from baseline
Time Frame
Baseline and 52 week after
Title
Clinical Laboratory Test: Haematology -Platelet Count
Description
Change from baseline
Time Frame
Baseline and 52 week after
Title
Clinical Laboratory Test: Haematology -Eosinophils
Description
Change from baseline
Time Frame
Baseline and 52 week after
Title
Clinical Laboratory Test: Haematology -Basophils
Description
Change from baseline
Time Frame
Baseline and 52 week after
Title
Clinical Laboratory Test: Haematology -Lymphocytes
Description
Change from baseline
Time Frame
Baseline and 52 week after
Title
Clinical Laboratory Test: Haematology -Monocytes
Description
Change from baseline
Time Frame
Baseline and 52 week after
Title
Clinical Laboratory Test: Haematology -Neutrophils
Description
Change from baseline
Time Frame
Baseline and 52 week after
Title
Clinical Laboratory Test: Clinical Chemistry- S-Alanine Aminotransferase
Description
Change from baseline
Time Frame
Baseline and 52 week after
Title
Clinical Laboratory Test: Clinical Chemistry- S-Aspartate Aminotransferase
Description
Change from baseline
Time Frame
Baseline and 52 week after
Title
Clinical Laboratory Test: Clinical Chemistry- S-Alkaline Phosphatase (ALP)
Description
Change from baseline
Time Frame
Baseline and 52 week after
Title
Clinical Laboratory Test: Clinical Chemistry- S-Creatinine
Description
Change from baseline
Time Frame
Baseline and 52 week after
Title
Clinical Laboratory Test: Clinical Chemistry- S-Total Bilirubin
Description
Change from baseline
Time Frame
Baseline and 52 week after
Title
Clinical Laboratory Test: Clinical Chemistry- S-Sodium
Description
Change from baseline
Time Frame
Baseline and 52 week after
Title
Clinical Laboratory Test: Clinical Chemistry- S-Potassium
Description
Change from baseline
Time Frame
Baseline and 52 week after
Title
Clinical Laboratory Test: Clinical Chemistry- S- Calcium
Description
Change from baseline
Time Frame
Baseline and 52 week after
Title
Clinical Laboratory Test: Clinical Chemistry- S-Albumin
Description
Change from baseline
Time Frame
Baseline and 52 week after
Title
Clinical Laboratory Test: Clinical Chemistry- S-Protein, Total
Description
Change from baseline
Time Frame
Baseline and 52 week after
Title
Clinical Laboratory Test: Clinical Chemistry- S-C-Reactive Protein
Description
Change from baseline
Time Frame
Baseline and 52 week after
Title
Clinical Laboratory Test: Clinical Chemistry- S-Urea Nitrogen
Description
Change from baseline
Time Frame
Baseline and 52 week after
Title
Vital Signs- Sitting Systolic Blood Pressure(SBP)
Description
Change from baseline
Time Frame
Baseline and 52 week after
Title
Vital Signs- Sitting Diastolic Blood Pressure(DBP)
Description
Change from baseline
Time Frame
Baseline and 52 week after
Title
Vital Signs- Pulse Rate
Description
Change from baseline
Time Frame
Baseline and 52 week after
Title
ECG Variables - Heart Rate
Description
Change from baseline
Time Frame
Baseline and 52 week after
Title
ECG Variables - QT Interval
Description
Change from baseline
Time Frame
Baseline and 52 week after
Title
ECG Variables - QTcB Interval
Description
Change from baseline
Time Frame
Baseline and 52 week after
Title
ECG Variables - QTcF Interval
Description
Change from baseline
Time Frame
Baseline and 52 week after
Title
ECG Variables - RR Interval
Description
Change from baseline
Time Frame
Baseline and 52 week after
Secondary Outcome Measure Information:
Title
Chronic Obstructive Pulmonary Disease (COPD) symptoms_Night-time Awakening
Description
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
Time Frame
Daily during run-in period and daily during 52-week randomization treatment
Title
Chronic Obstructive Pulmonary Disease (COPD) symptoms_Breathlessness
Description
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
Time Frame
Daily during run-in period and daily during 52-week randomization treatment
Title
Chronic Obstructive Pulmonary Disease (COPD) symptoms_cough
Description
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
Time Frame
Daily during run-in period and daily during 52-week randomization treatment
Title
Forced Expiratory Volume in 1 Second (FEV1) Measured With the Spirometer at the Clinic
Description
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 Frame
Before randomization, 0, 4, 8, 17, 26, 34, 43 and 52 weeks after randomization
Title
Forced Vital Capacity (FVC) Measured With the Spirometer at the Clinic
Description
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 Frame
Before randomization, 0, 4, 8, 17, 26, 34, 43 and 52 weeks after randomization
Title
Time to First COPD Exacerbation
Description
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.
Time Frame
Daily during 52-week randomization treatment
Title
Number of COPD Exacerbations Over the Study Treatment Period
Description
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
Time Frame
Daily during 52-week randomization treatment
Title
Rescue Medication Use
Description
The change from run-in period and daily during 52-week randomization treatment
Time Frame
Daily during 52-week randomization treatment
Title
Health Related Quality of Life (HRQL) Based on the St. George's Respiratory Questionnaire (SGRQ)
Description
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).
Time Frame
Daily during run-in period and daily 52-week randomization treatment
Title
Morning Peak Expiratory Flow (PEF) Measured at Home
Description
The change from Run-in period average to 52-week randomization Treatment period average for each treatment group
Time Frame
Daily during run-in period and daily 52-week randomization treatment
Title
Evening Peak Expiratory Flow (PEF) Measured at Home
Description
The change from Run-in period average to 52-week randomization Treatment period average for each treatment group
Time Frame
Daily during run-in period and daily 52-week randomization treatment
Title
Morning FEV1 Measured by the Subjects at Home
Description
The change from run-in period and daily during 52-week randomization treatment
Time Frame
Daily during run-in period and daily 52-week randomization treatment
Title
Evening FEV1 Measured by the Subjects at Home
Description
The change from run-in period and daily during 52-week randomization treatment
Time Frame
Daily during run-in period and daily 52-week randomization treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomas Andersson, MD
Organizational Affiliation
AstraZeneca, R&D, Lund, Sweden
Official's Role
Study Chair
Facility Information:
Facility Name
Research Site
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
Research Site
City
Toyota
State/Province
Aichi
Country
Japan
Facility Name
Research Site
City
Yanagawa
State/Province
Fukuoka
Country
Japan
Facility Name
Research Site
City
Asahikawa
State/Province
Hokkaido
Country
Japan
Facility Name
Research Site
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Research Site
City
Itami
State/Province
Hyogo
Country
Japan
Facility Name
Research Site
City
Hitachi
State/Province
Ibaraki
Country
Japan
Facility Name
Research Site
City
Tsukuba
State/Province
Ibaraki
Country
Japan
Facility Name
Research Site
City
Sakaide
State/Province
Kagawa
Country
Japan
Facility Name
Research Site
City
Fujisawa
State/Province
Kanagawa
Country
Japan
Facility Name
Research Site
City
Yokohama
State/Province
Kanagawa
Country
Japan
Facility Name
Research Site
City
Koshi
State/Province
Kumamoto
Country
Japan
Facility Name
Research Site
City
Shibata
State/Province
Miyagi
Country
Japan
Facility Name
Research Site
City
Chuo
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Setagaya
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Hiroshima
Country
Japan
Facility Name
Research Site
City
Kyoto
Country
Japan

12. IPD Sharing Statement

Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=397&filename=CSR-D589DC00008.pdf
Description
Related Info

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

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