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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01070784
First received: February 11, 2010
Last updated: October 7, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Drug: Symbicort Turbuhaler (Budesonide/formoterol)
Drug: Drug: any available COPD treatment; investigator to decide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Clinical Laboratory Test: Haematology -Erythrocytes [ Time Frame: Baseline and 52 week after ] [ Designated as safety issue: Yes ]
    Mean change from Baseline

  • Clinical Laboratory Test: Haematology -Haemoglobin [ Time Frame: Baseline and 52 week after ] [ Designated as safety issue: Yes ]
    Change from baseline

  • Clinical Laboratory Test: Haematology -Leucocytes [ Time Frame: Baseline and 52 week after ] [ Designated as safety issue: Yes ]
    Change from baseline

  • Clinical Laboratory Test: Haematology -Platelet Count [ Time Frame: Baseline and 52 week after ] [ Designated as safety issue: Yes ]
    Change from baseline

  • Clinical Laboratory Test: Haematology -Eosinophils [ Time Frame: Baseline and 52 week after ] [ Designated as safety issue: Yes ]
    Change from baseline

  • Clinical Laboratory Test: Haematology -Basophils [ Time Frame: Baseline and 52 week after ] [ Designated as safety issue: Yes ]
    Change from baseline

  • Clinical Laboratory Test: Haematology -Lymphocytes [ Time Frame: Baseline and 52 week after ] [ Designated as safety issue: Yes ]
    Change from baseline

  • Clinical Laboratory Test: Haematology -Monocytes [ Time Frame: Baseline and 52 week after ] [ Designated as safety issue: Yes ]
    Change from baseline

  • Clinical Laboratory Test: Haematology -Neutrophils [ Time Frame: Baseline and 52 week after ] [ Designated as safety issue: Yes ]
    Change from baseline

  • Clinical Laboratory Test: Clinical Chemistry- S-Alanine Aminotransferase [ Time Frame: Baseline and 52 week after ] [ Designated as safety issue: Yes ]
    Change from baseline

  • Clinical Laboratory Test: Clinical Chemistry- S-Aspartate Aminotransferase [ Time Frame: Baseline and 52 week after ] [ Designated as safety issue: Yes ]
    Change from baseline

  • Clinical Laboratory Test: Clinical Chemistry- S-Alkaline Phosphatase (ALP) [ Time Frame: Baseline and 52 week after ] [ Designated as safety issue: Yes ]
    Change from baseline

  • Clinical Laboratory Test: Clinical Chemistry- S-Creatinine [ Time Frame: Baseline and 52 week after ] [ Designated as safety issue: Yes ]
    Change from baseline

  • Clinical Laboratory Test: Clinical Chemistry- S-Total Bilirubin [ Time Frame: Baseline and 52 week after ] [ Designated as safety issue: Yes ]
    Change from baseline

  • Clinical Laboratory Test: Clinical Chemistry- S-Sodium [ Time Frame: Baseline and 52 week after ] [ Designated as safety issue: Yes ]
    Change from baseline

  • Clinical Laboratory Test: Clinical Chemistry- S-Potassium [ Time Frame: Baseline and 52 week after ] [ Designated as safety issue: Yes ]
    Change from baseline

  • Clinical Laboratory Test: Clinical Chemistry- S- Calcium [ Time Frame: Baseline and 52 week after ] [ Designated as safety issue: Yes ]
    Change from baseline

  • Clinical Laboratory Test: Clinical Chemistry- S-Albumin [ Time Frame: Baseline and 52 week after ] [ Designated as safety issue: Yes ]
    Change from baseline

  • Clinical Laboratory Test: Clinical Chemistry- S-Protein, Total [ Time Frame: Baseline and 52 week after ] [ Designated as safety issue: Yes ]
    Change from baseline

  • Clinical Laboratory Test: Clinical Chemistry- S-C-Reactive Protein [ Time Frame: Baseline and 52 week after ] [ Designated as safety issue: Yes ]
    Change from baseline

  • Clinical Laboratory Test: Clinical Chemistry- S-Urea Nitrogen [ Time Frame: Baseline and 52 week after ] [ Designated as safety issue: Yes ]
    Change from baseline

  • Vital Signs- Sitting Systolic Blood Pressure(SBP) [ Time Frame: Baseline and 52 week after ] [ Designated as safety issue: Yes ]
    Change from baseline

  • Vital Signs- Sitting Diastolic Blood Pressure(DBP) [ Time Frame: Baseline and 52 week after ] [ Designated as safety issue: Yes ]
    Change from baseline

  • Vital Signs- Pulse Rate [ Time Frame: Baseline and 52 week after ] [ Designated as safety issue: Yes ]
    Change from baseline

  • ECG Variables - Heart Rate [ Time Frame: Baseline and 52 week after ] [ Designated as safety issue: Yes ]
    Change from baseline

  • ECG Variables - QT Interval [ Time Frame: Baseline and 52 week after ] [ Designated as safety issue: Yes ]
    Change from baseline

  • ECG Variables - QTcB Interval [ Time Frame: Baseline and 52 week after ] [ Designated as safety issue: Yes ]
    Change from baseline

  • ECG Variables - QTcF Interval [ Time Frame: Baseline and 52 week after ] [ Designated as safety issue: Yes ]
    Change from baseline

  • ECG Variables - RR Interval [ Time Frame: Baseline and 52 week after ] [ Designated as safety issue: Yes ]
    Change from baseline


Secondary Outcome Measures:
  • Chronic Obstructive Pulmonary Disease (COPD) symptoms_Night-time Awakening [ Time Frame: Daily during run-in period and daily during 52-week randomization treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: Daily during run-in period and daily during 52-week randomization treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: Daily during run-in period and daily during 52-week randomization treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: Before randomization, 0, 4, 8, 17, 26, 34, 43 and 52 weeks after randomization ] [ Designated as safety issue: No ]
    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 [ Time Frame: Before randomization, 0, 4, 8, 17, 26, 34, 43 and 52 weeks after randomization ] [ Designated as safety issue: No ]
    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 [ Time Frame: Daily during 52-week randomization treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: Daily during 52-week randomization treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: Daily during 52-week randomization treatment ] [ Designated as safety issue: No ]
    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) [ Time Frame: Daily during run-in period and daily 52-week randomization treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: Daily during run-in period and daily 52-week randomization treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: Daily during run-in period and daily 52-week randomization treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: Daily during run-in period and daily 52-week randomization treatment ] [ Designated as safety issue: No ]
    The change from run-in period and daily during 52-week randomization treatment

  • Evening FEV1 Measured by the Subjects at Home [ Time Frame: Daily during run-in period and daily 52-week randomization treatment ] [ Designated as safety issue: No ]
    The change from run-in period and daily during 52-week randomization treatment


Enrollment: 328
Study Start Date: January 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Symbicort Turbuhaler (Budesonide/formoterol)
2 x 160/4.5 microgram, inhalation, bid, 52 weeks
Other Name: 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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01070784

Locations
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
Research Site
Hiroshima, Japan
Research Site
Kyoto, Japan
Sponsors and Collaborators
AstraZeneca
Investigators
Study Chair: Tomas Andersson, MD AstraZeneca, R&D, Lund, Sweden
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01070784     History of Changes
Other Study ID Numbers: D589DC00008
Study First Received: February 11, 2010
Results First Received: October 8, 2012
Last Updated: October 7, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by AstraZeneca:
Symbicort
Safety
Efficacy
COPD
Japanese

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Budesonide
Formoterol
Symbicort
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 23, 2014