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

Chronic Obstructive Pulmonary Disease Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01070784
• Other study ID #: D589DC00008
• Status: Completed
• Phase: Phase 3
• First received: February 11, 2010
• Last updated: April 14, 2014
• Start date: January 2010
• Est. completion date: October 2011

Study information

• Verified date: April 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 328
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Symbicort Turbuhaler (Budesonide/formoterol)
2 x 160/4.5 microgram, inhalation, bid, 52 weeks
• Drug: any available COPD treatment; investigator to decide
According to investigator decision, 52 weeks, Standard COPD treatment according to investigator decision

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Laboratory Test: Haematology -Erythrocytes	Mean change from Baseline	Baseline and 52 week after	Yes
Primary	Clinical Laboratory Test: Haematology -Haemoglobin	Change from baseline	Baseline and 52 week after	Yes
Primary	Clinical Laboratory Test: Haematology -Leucocytes	Change from baseline	Baseline and 52 week after	Yes
Primary	Clinical Laboratory Test: Haematology -Platelet Count	Change from baseline	Baseline and 52 week after	Yes
Primary	Clinical Laboratory Test: Haematology -Eosinophils	Change from baseline	Baseline and 52 week after	Yes
Primary	Clinical Laboratory Test: Haematology -Basophils	Change from baseline	Baseline and 52 week after	Yes
Primary	Clinical Laboratory Test: Haematology -Lymphocytes	Change from baseline	Baseline and 52 week after	Yes
Primary	Clinical Laboratory Test: Haematology -Monocytes	Change from baseline	Baseline and 52 week after	Yes
Primary	Clinical Laboratory Test: Haematology -Neutrophils	Change from baseline	Baseline and 52 week after	Yes
Primary	Clinical Laboratory Test: Clinical Chemistry- S-Alanine Aminotransferase	Change from baseline	Baseline and 52 week after	Yes
Primary	Clinical Laboratory Test: Clinical Chemistry- S-Aspartate Aminotransferase	Change from baseline	Baseline and 52 week after	Yes
Primary	Clinical Laboratory Test: Clinical Chemistry- S-Alkaline Phosphatase (ALP)	Change from baseline	Baseline and 52 week after	Yes
Primary	Clinical Laboratory Test: Clinical Chemistry- S-Creatinine	Change from baseline	Baseline and 52 week after	Yes
Primary	Clinical Laboratory Test: Clinical Chemistry- S-Total Bilirubin	Change from baseline	Baseline and 52 week after	Yes
Primary	Clinical Laboratory Test: Clinical Chemistry- S-Sodium	Change from baseline	Baseline and 52 week after	Yes
Primary	Clinical Laboratory Test: Clinical Chemistry- S-Potassium	Change from baseline	Baseline and 52 week after	Yes
Primary	Clinical Laboratory Test: Clinical Chemistry- S- Calcium	Change from baseline	Baseline and 52 week after	Yes
Primary	Clinical Laboratory Test: Clinical Chemistry- S-Albumin	Change from baseline	Baseline and 52 week after	Yes
Primary	Clinical Laboratory Test: Clinical Chemistry- S-Protein, Total	Change from baseline	Baseline and 52 week after	Yes
Primary	Clinical Laboratory Test: Clinical Chemistry- S-C-Reactive Protein	Change from baseline	Baseline and 52 week after	Yes
Primary	Clinical Laboratory Test: Clinical Chemistry- S-Urea Nitrogen	Change from baseline	Baseline and 52 week after	Yes
Primary	Vital Signs- Sitting Systolic Blood Pressure(SBP)	Change from baseline	Baseline and 52 week after	Yes
Primary	Vital Signs- Sitting Diastolic Blood Pressure(DBP)	Change from baseline	Baseline and 52 week after	Yes
Primary	Vital Signs- Pulse Rate	Change from baseline	Baseline and 52 week after	Yes
Primary	ECG Variables - Heart Rate	Change from baseline	Baseline and 52 week after	Yes
Primary	ECG Variables - QT Interval	Change from baseline	Baseline and 52 week after	Yes
Primary	ECG Variables - QTcB Interval	Change from baseline	Baseline and 52 week after	Yes
Primary	ECG Variables - QTcF Interval	Change from baseline	Baseline and 52 week after	Yes
Primary	ECG Variables - RR Interval	Change from baseline	Baseline and 52 week after	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Rescue Medication Use	The change from run-in period and daily during 52-week randomization treatment	Daily during 52-week randomization treatment	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

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