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

April 14, 2014 updated by: AstraZeneca

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
328

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

36 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Clinical Laboratory Test: Haematology -Erythrocytes
Time Frame: Baseline and 52 week after
Mean change from Baseline
Baseline and 52 week after
Clinical Laboratory Test: Haematology -Haemoglobin
Time Frame: Baseline and 52 week after
Change from baseline
Baseline and 52 week after
Clinical Laboratory Test: Haematology -Leucocytes
Time Frame: Baseline and 52 week after
Change from baseline
Baseline and 52 week after
Clinical Laboratory Test: Haematology -Platelet Count
Time Frame: Baseline and 52 week after
Change from baseline
Baseline and 52 week after
Clinical Laboratory Test: Haematology -Eosinophils
Time Frame: Baseline and 52 week after
Change from baseline
Baseline and 52 week after
Clinical Laboratory Test: Haematology -Basophils
Time Frame: Baseline and 52 week after
Change from baseline
Baseline and 52 week after
Clinical Laboratory Test: Haematology -Lymphocytes
Time Frame: Baseline and 52 week after
Change from baseline
Baseline and 52 week after
Clinical Laboratory Test: Haematology -Monocytes
Time Frame: Baseline and 52 week after
Change from baseline
Baseline and 52 week after
Clinical Laboratory Test: Haematology -Neutrophils
Time Frame: Baseline and 52 week after
Change from baseline
Baseline and 52 week after
Clinical Laboratory Test: Clinical Chemistry- S-Alanine Aminotransferase
Time Frame: Baseline and 52 week after
Change from baseline
Baseline and 52 week after
Clinical Laboratory Test: Clinical Chemistry- S-Aspartate Aminotransferase
Time Frame: Baseline and 52 week after
Change from baseline
Baseline and 52 week after
Clinical Laboratory Test: Clinical Chemistry- S-Alkaline Phosphatase (ALP)
Time Frame: Baseline and 52 week after
Change from baseline
Baseline and 52 week after
Clinical Laboratory Test: Clinical Chemistry- S-Creatinine
Time Frame: Baseline and 52 week after
Change from baseline
Baseline and 52 week after
Clinical Laboratory Test: Clinical Chemistry- S-Total Bilirubin
Time Frame: Baseline and 52 week after
Change from baseline
Baseline and 52 week after
Clinical Laboratory Test: Clinical Chemistry- S-Sodium
Time Frame: Baseline and 52 week after
Change from baseline
Baseline and 52 week after
Clinical Laboratory Test: Clinical Chemistry- S-Potassium
Time Frame: Baseline and 52 week after
Change from baseline
Baseline and 52 week after
Clinical Laboratory Test: Clinical Chemistry- S- Calcium
Time Frame: Baseline and 52 week after
Change from baseline
Baseline and 52 week after
Clinical Laboratory Test: Clinical Chemistry- S-Albumin
Time Frame: Baseline and 52 week after
Change from baseline
Baseline and 52 week after
Clinical Laboratory Test: Clinical Chemistry- S-Protein, Total
Time Frame: Baseline and 52 week after
Change from baseline
Baseline and 52 week after
Clinical Laboratory Test: Clinical Chemistry- S-C-Reactive Protein
Time Frame: Baseline and 52 week after
Change from baseline
Baseline and 52 week after
Clinical Laboratory Test: Clinical Chemistry- S-Urea Nitrogen
Time Frame: Baseline and 52 week after
Change from baseline
Baseline and 52 week after
Vital Signs- Sitting Systolic Blood Pressure(SBP)
Time Frame: Baseline and 52 week after
Change from baseline
Baseline and 52 week after
Vital Signs- Sitting Diastolic Blood Pressure(DBP)
Time Frame: Baseline and 52 week after
Change from baseline
Baseline and 52 week after
Vital Signs- Pulse Rate
Time Frame: Baseline and 52 week after
Change from baseline
Baseline and 52 week after
ECG Variables - Heart Rate
Time Frame: Baseline and 52 week after
Change from baseline
Baseline and 52 week after
ECG Variables - QT Interval
Time Frame: Baseline and 52 week after
Change from baseline
Baseline and 52 week after
ECG Variables - QTcB Interval
Time Frame: Baseline and 52 week after
Change from baseline
Baseline and 52 week after
ECG Variables - QTcF Interval
Time Frame: Baseline and 52 week after
Change from baseline
Baseline and 52 week after
ECG Variables - RR Interval
Time Frame: Baseline and 52 week after
Change from baseline
Baseline and 52 week after

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Daily during run-in period and daily during 52-week randomization treatment
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
Daily during run-in period and daily during 52-week randomization treatment
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
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
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.
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
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.
Before randomization, 0, 4, 8, 17, 26, 34, 43 and 52 weeks after randomization
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.
Daily during 52-week randomization treatment
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
Daily during 52-week randomization treatment
Rescue Medication Use
Time Frame: Daily during 52-week randomization treatment
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)
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).
Daily during run-in period and daily 52-week randomization treatment
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
Daily during run-in period and daily 52-week randomization treatment
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
Daily during run-in period and daily 52-week randomization treatment
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
Daily during run-in period and daily 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
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Tomas Andersson, MD, AstraZeneca, R&D, Lund, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 11, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 18, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 29, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D589DC00008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Obstructive Pulmonary Disease

Clinical Trials on Symbicort Turbuhaler (Budesonide/formoterol)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings