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Completed

NCT Number: NCT01070784

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

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Nagoya, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Symbicort Turbuhaler (Budesonide/formoterol)

Drug

2 x 160/4.5 microgram, inhalation, bid, 52 weeks

Other names: Symbicort Turbuhaler

Drug: any available COPD treatment; investigator to decide

Drug

According to investigator decision, 52 weeks, Standard COPD treatment according to investigator decision

Primary outcomes

  1. Clinical Laboratory Test: Haematology -Erythrocytes

    Time frame: Baseline and 52 week after

    Mean change from Baseline

  2. Clinical Laboratory Test: Haematology -Haemoglobin

    Time frame: Baseline and 52 week after

    Change from baseline

  3. Clinical Laboratory Test: Haematology -Leucocytes

    Time frame: Baseline and 52 week after

    Change from baseline

  4. Clinical Laboratory Test: Haematology -Platelet Count

    Time frame: Baseline and 52 week after

    Change from baseline

  5. Clinical Laboratory Test: Haematology -Eosinophils

    Time frame: Baseline and 52 week after

    Change from baseline

  6. Clinical Laboratory Test: Haematology -Basophils

    Time frame: Baseline and 52 week after

    Change from baseline

  7. Clinical Laboratory Test: Haematology -Lymphocytes

    Time frame: Baseline and 52 week after

    Change from baseline

  8. Clinical Laboratory Test: Haematology -Monocytes

    Time frame: Baseline and 52 week after

    Change from baseline

  9. Clinical Laboratory Test: Haematology -Neutrophils

    Time frame: Baseline and 52 week after

    Change from baseline

  10. Clinical Laboratory Test: Clinical Chemistry- S-Alanine Aminotransferase

    Time frame: Baseline and 52 week after

    Change from baseline

  11. Clinical Laboratory Test: Clinical Chemistry- S-Aspartate Aminotransferase

    Time frame: Baseline and 52 week after

    Change from baseline

  12. Clinical Laboratory Test: Clinical Chemistry- S-Alkaline Phosphatase (ALP)

    Time frame: Baseline and 52 week after

    Change from baseline

  13. Clinical Laboratory Test: Clinical Chemistry- S-Creatinine

    Time frame: Baseline and 52 week after

    Change from baseline

  14. Clinical Laboratory Test: Clinical Chemistry- S-Total Bilirubin

    Time frame: Baseline and 52 week after

    Change from baseline

  15. Clinical Laboratory Test: Clinical Chemistry- S-Sodium

    Time frame: Baseline and 52 week after

    Change from baseline

  16. Clinical Laboratory Test: Clinical Chemistry- S-Potassium

    Time frame: Baseline and 52 week after

    Change from baseline

  17. Clinical Laboratory Test: Clinical Chemistry- S- Calcium

    Time frame: Baseline and 52 week after

    Change from baseline

  18. Clinical Laboratory Test: Clinical Chemistry- S-Albumin

    Time frame: Baseline and 52 week after

    Change from baseline

  19. Clinical Laboratory Test: Clinical Chemistry- S-Protein, Total

    Time frame: Baseline and 52 week after

    Change from baseline

  20. Clinical Laboratory Test: Clinical Chemistry- S-C-Reactive Protein

    Time frame: Baseline and 52 week after

    Change from baseline

  21. Clinical Laboratory Test: Clinical Chemistry- S-Urea Nitrogen

    Time frame: Baseline and 52 week after

    Change from baseline

  22. Vital Signs- Sitting Systolic Blood Pressure(SBP)

    Time frame: Baseline and 52 week after

    Change from baseline

  23. Vital Signs- Sitting Diastolic Blood Pressure(DBP)

    Time frame: Baseline and 52 week after

    Change from baseline

  24. Vital Signs- Pulse Rate

    Time frame: Baseline and 52 week after

    Change from baseline

  25. ECG Variables - Heart Rate

    Time frame: Baseline and 52 week after

    Change from baseline

  26. ECG Variables - QT Interval

    Time frame: Baseline and 52 week after

    Change from baseline

  27. ECG Variables - QTcB Interval

    Time frame: Baseline and 52 week after

    Change from baseline

  28. ECG Variables - QTcF Interval

    Time frame: Baseline and 52 week after

    Change from baseline

  29. ECG Variables - RR Interval

    Time frame: Baseline and 52 week after

    Change from baseline

Secondary outcomes

  1. Chronic Obstructive Pulmonary Disease (COPD) symptoms_Night-time Awakening

    Time frame: Daily during run-in period and daily during 52-week randomization treatment

    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

  2. Chronic Obstructive Pulmonary Disease (COPD) symptoms_Breathlessness

    Time frame: Daily during run-in period and daily during 52-week randomization treatment

    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

  3. Chronic Obstructive Pulmonary Disease (COPD) symptoms_cough

    Time frame: Daily during run-in period and daily during 52-week randomization treatment

    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

  4. 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

    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.

  5. 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

    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.

  6. Time to First COPD Exacerbation

    Time frame: Daily during 52-week randomization treatment

    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.

  7. Number of COPD Exacerbations Over the Study Treatment Period

    Time frame: Daily during 52-week randomization treatment

    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

  8. Rescue Medication Use

    Time frame: Daily during 52-week randomization treatment

    The change from run-in period and daily during 52-week randomization treatment

  9. 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

    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).

  10. Morning Peak Expiratory Flow (PEF) Measured at Home

    Time frame: Daily during run-in period and daily 52-week randomization treatment

    The change from Run-in period average to 52-week randomization Treatment period average for each treatment group

  11. Evening Peak Expiratory Flow (PEF) Measured at Home

    Time frame: Daily during run-in period and daily 52-week randomization treatment

    The change from Run-in period average to 52-week randomization Treatment period average for each treatment group

  12. Morning FEV1 Measured by the Subjects at Home

    Time frame: Daily during run-in period and daily 52-week randomization treatment

    The change from run-in period and daily during 52-week randomization treatment

  13. Evening FEV1 Measured by the Subjects at Home

    Time frame: Daily during run-in period and daily 52-week randomization treatment

    The change from run-in period and daily during 52-week randomization treatment

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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)

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Feb 18, 2010
Registry last updated
Apr 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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