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Study to Evaluate the Safety and Efficacy of Formoterol in a Daily Dose of 18 µg (9 µg Twice Daily) in Japanese Chronic Obstructive Pulmonary Disease (COPD) Patients

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Formoterol (OT)
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 Chronic Obstructive Pulmonary Disease, COPD, Japanese, Phase 3, Safety, OT, Oxis

Eligibility Criteria

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

Inclusion Criteria:

  • Outpatients, men or women ≥ 40 years
  • A clinical diagnosis of COPD according to guidelines, and current COPD symptoms.
  • Post-bronchodilator FEV1 < 80% of predicted normal value and FEV1/FVC < 70%, post-bronchodilator

Exclusion Criteria:

  • A history and/or current clinical diagnosis of asthma and atopic diseases such as Allergic rhinitis
  • Patients who have experienced COPD exacerbation requiring at least one of the following treatment, hospitalisation and/or a course of systemic steroid within 4 weeks prior to the study start.
  • Significant or unstable ischaemic heart disease, arrhythmia, cardiomyopathy, heart failure, uncontrolled hypertension as defined by the investigator, or any other relevant cardiovascular disorder as judged by the investigator

Sites / Locations

  • Research Site
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Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Formoterol 9 μg/dose

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 Basophil
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-Total Protein
Change from baseline
Clinical Laboratory Test: Clinical Chemistry - S-Blood Urea Nitrogen (BUN)
Change from baseline
Vital Signs- Sitting SBP
Change from baseline
Vital Signs- Sitting 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

Forced Expiratory Volume in One Second (FEV1)
The ratio of the average value of available data for mean from Weeks 0, 4, 8, 17, 26, 34, 43 and 52 to the baseline for each treatment group
Forced Vital Capacity (FVC)
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
Morning Peak Expiratory Flow(PEF)
The change from Run-in period average to Treatment period average for each treatment group
Evening Peak Expiratory Flow (PEF)
The change from Run-in period average to Treatment period average for each treatment group
Night-time Awakening Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms
There are 5 alternatives (scored 0 to 4, with 4 being the most severe condition). The change from Run-in period average to Treatment period average for each treatment group
Daytime Breathlessness Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms
There are 5 alternatives (scored 0 to 4, with 4 being the most severe condition). The change from Run-in period average to Treatment period average for each treatment group
Daytime Cough Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms
There are 5 alternatives (scored 0 to 4, with 4 being the most severe condition). The change from Run-in period average to Treatment period average for each treatment group
Total Chronic Obstructive Pulmonary Disease (COPD) Symptom Score
The Total COPD Symptom score is the sum of the measures night-time awakening, breathlessness and cough, ranges from 0 to 12 with 12 being the most severe. The change from Run-in period average to Treatment period average for each treatment group.
Number of COPD Exacerbations Over the 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 was presented here.
Use of SABA (Salbutamol) as Reliever Medication
The change from Run-in period average to Treatment period average for each treatment group.
St George's Respiratory Questionnaire (SGRQ) Total Score
SGRQ total score shows the impact of COPD on patient's health status, and expressed as a percentage of impairment with scale from 0 (best health status) to 100 (worst possible status). A negative rate of decline shows decreasing SGRQ total score (or improved health) over time, while a positive value shows increasing score (or worsen health). The change from Run-in period average to Treatment period average for each treatment group

Full Information

First Posted
January 12, 2010
Last Updated
December 4, 2012
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT01047553
Brief Title
Study to Evaluate the Safety and Efficacy of Formoterol in a Daily Dose of 18 µg (9 µg Twice Daily) in Japanese Chronic Obstructive Pulmonary Disease (COPD) Patients
Official Title
An Open Phase III, Multi-centre 52-week, Parallel-group Study Evaluating the Safety and Efficacy of Formoterol 18 μg Daily Dose Compared With Standard COPD Treatment, in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is a multicentre, open, randomised, parallel-group study with formoterol 9 μg one inhalation b.i.d, or standard COPD therapy. Standard (reference) COPD treatment arm should be the group to refer to when safety results of formoterol arm will be evaluated. 240 patients with moderate-to-severe COPD will be randomised (120 patients in the formoterol-arm and 120 patients on standard COPD therapy).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Chronic Obstructive Pulmonary Disease, COPD, Japanese, Phase 3, Safety, OT, Oxis

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Formoterol 9 μg/dose
Intervention Type
Drug
Intervention Name(s)
Formoterol (OT)
Other Intervention Name(s)
Oxis Turbuhaler®
Intervention Description
9 μg/dose, Inhaled, twice daily for 52 weeks
Primary Outcome Measure Information:
Title
Clinical Laboratory Test: Haematology -Erythrocytes
Description
Mean change from Baseline
Time Frame
Baseline and week 52
Title
Clinical Laboratory Test: Haematology -Haemoglobin
Description
Change from baseline
Time Frame
Baseline and week 52
Title
Clinical Laboratory Test: Haematology-Leucocytes
Description
Change from baseline
Time Frame
Baseline and week 52
Title
Clinical Laboratory Test: Haematology-Platelet Count
Description
Change from baseline
Time Frame
Baseline and week 52
Title
Clinical Laboratory Test: Haematology Eosinophils
Description
Change from baseline
Time Frame
baseline and week 52
Title
Clinical Laboratory Test: Haematology Basophil
Description
Change from baseline
Time Frame
Baseline and week 52
Title
Clinical Laboratory Test: Haematology-Lymphocytes
Description
Change from baseline
Time Frame
Baseline and week 52
Title
Clinical Laboratory Test: Haematology-Monocytes
Description
Change from baseline
Time Frame
Baseline and week 52
Title
Clinical Laboratory Test: Haematology -Neutrophils
Description
Change from baseline
Time Frame
Baseline and week 52
Title
Clinical Laboratory Test: Clinical Chemistry- S-Alanine Aminotransferase
Description
Change from baseline
Time Frame
Baseline and week 52
Title
Clinical Laboratory Test: Clinical Chemistry-S-Aspartate Aminotransferase
Description
Change from baseline
Time Frame
Baseline and week 52
Title
Clinical Laboratory Test: Clinical Chemistry-S-Alkaline Phosphatase (ALP)
Description
Change from baseline
Time Frame
Baseline and week 52
Title
Clinical Laboratory Test: Clinical Chemistry-S-Creatinine
Description
Change from Baseline
Time Frame
Baseline and week 52
Title
Clinical Laboratory Test: Clinical Chemistry-S-Total Bilirubin
Description
Change from baseline
Time Frame
Baseline and week 52
Title
Clinical Laboratory Test: Clinical Chemistry-S-Sodium
Description
Change from baseline
Time Frame
Baseline and week 52
Title
Clinical Laboratory Test: Clinical Chemistry-S-Potassium
Description
Change from baseline
Time Frame
Baseline and week 52
Title
Clinical Laboratory Test: Clinical Chemistry-S- Calcium
Description
Change from baseline
Time Frame
Baseline and week 52
Title
Clinical Laboratory Test: Clinical Chemistry-S-Albumin
Description
Change from baseline
Time Frame
Baseline and week 52
Title
Clinical Laboratory Test: Clinical Chemistry-S-Total Protein
Description
Change from baseline
Time Frame
Baseline and week 52
Title
Clinical Laboratory Test: Clinical Chemistry - S-Blood Urea Nitrogen (BUN)
Description
Change from baseline
Time Frame
Baseline and week 52
Title
Vital Signs- Sitting SBP
Description
Change from baseline
Time Frame
Baseline and week 52
Title
Vital Signs- Sitting DBP
Description
Change from baseline
Time Frame
Baseline and week 52
Title
Vital Signs - Pulse Rate
Description
Change from baseline
Time Frame
Baseline and week 52
Title
ECG Variables - Heart Rate
Description
Change from baseline
Time Frame
Baseline and week 52
Title
ECG Variables - QT Interval
Description
Change from baseline
Time Frame
Baseline and week 52
Title
ECG Variables - QTcB Interval
Description
Change from baseline
Time Frame
Baseline and week 52
Title
ECG Variables QTcF Interval
Description
Change from baseline
Time Frame
Baseline and week 52
Title
ECG Variables RR Interval
Description
Change from baseline
Time Frame
Baseline and week 52
Secondary Outcome Measure Information:
Title
Forced Expiratory Volume in One Second (FEV1)
Description
The ratio of the average value of available data for mean from Weeks 0, 4, 8, 17, 26, 34, 43 and 52 to the baseline for each treatment group
Time Frame
Before randomization, 0, 4, 8, 17, 26, 34, 43 and 52 weeks after randomization
Title
Forced Vital Capacity (FVC)
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
Time Frame
Before randomization, 0, 4, 8, 17, 26, 34, 43 and 52 weeks after randomization
Title
Morning Peak Expiratory Flow(PEF)
Description
The change from Run-in period average to Treatment period average for each treatment group
Time Frame
Daily during run-in period (14 - 18 days before Randomisation visit)and daily during 52-week randomization treatment
Title
Evening Peak Expiratory Flow (PEF)
Description
The change from Run-in period average to Treatment period average for each treatment group
Time Frame
Daily during run-in period (14 - 18 days before Randomisation visit) and daily during 52-week randomization treatment
Title
Night-time Awakening Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms
Description
There are 5 alternatives (scored 0 to 4, with 4 being the most severe condition). The change from Run-in period average to Treatment period average for each treatment group
Time Frame
Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment
Title
Daytime Breathlessness Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms
Description
There are 5 alternatives (scored 0 to 4, with 4 being the most severe condition). The change from Run-in period average to Treatment period average for each treatment group
Time Frame
Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment
Title
Daytime Cough Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms
Description
There are 5 alternatives (scored 0 to 4, with 4 being the most severe condition). The change from Run-in period average to Treatment period average for each treatment group
Time Frame
Daily during run-in period (14 - 18 days before Randomisation visit) and daily during 52-week randomization treatment
Title
Total Chronic Obstructive Pulmonary Disease (COPD) Symptom Score
Description
The Total COPD Symptom score is the sum of the measures night-time awakening, breathlessness and cough, ranges from 0 to 12 with 12 being the most severe. The change from Run-in period average to Treatment period average for each treatment group.
Time Frame
Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment
Title
Number of COPD Exacerbations Over the 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 was presented here.
Time Frame
Daily during 52-week randomization treatment
Title
Use of SABA (Salbutamol) as Reliever Medication
Description
The change from Run-in period average to Treatment period average for each treatment group.
Time Frame
Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment
Title
St George's Respiratory Questionnaire (SGRQ) Total Score
Description
SGRQ total score shows the impact of COPD on patient's health status, and expressed as a percentage of impairment with scale from 0 (best health status) to 100 (worst possible status). A negative rate of decline shows decreasing SGRQ total score (or improved health) over time, while a positive value shows increasing score (or worsen health). The change from Run-in period average to Treatment period average for each treatment group
Time Frame
Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Outpatients, men or women ≥ 40 years A clinical diagnosis of COPD according to guidelines, and current COPD symptoms. Post-bronchodilator FEV1 < 80% of predicted normal value and FEV1/FVC < 70%, post-bronchodilator Exclusion Criteria: A history and/or current clinical diagnosis of asthma and atopic diseases such as Allergic rhinitis Patients who have experienced COPD exacerbation requiring at least one of the following treatment, hospitalisation and/or a course of systemic steroid within 4 weeks prior to the study start. Significant or unstable ischaemic heart disease, arrhythmia, cardiomyopathy, heart failure, uncontrolled hypertension as defined by the investigator, or any other relevant cardiovascular disorder as judged by the investigator
Facility Information:
Facility Name
Research Site
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
Research Site
City
Akita-shi
State/Province
Akita
Country
Japan
Facility Name
Research Site
City
Chitose
State/Province
Hokkaido
Country
Japan
Facility Name
Research Site
City
Obihiro
State/Province
Hokkaido
Country
Japan
Facility Name
Research Site
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Research Site
City
AKO
State/Province
Hyogo
Country
Japan
Facility Name
Research Site
City
Kobe-shi
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
Kanazawa
State/Province
Ishikawa
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
Kawasaki-shi
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
Nagaoka
State/Province
Niigata
Country
Japan
Facility Name
Research Site
City
Saiki-shi
State/Province
Oita
Country
Japan
Facility Name
Research Site
City
Moriguchi
State/Province
Osaka
Country
Japan
Facility Name
Research Site
City
Matsue
State/Province
Shimane
Country
Japan
Facility Name
Research Site
City
Bunkyo
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Chuo
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Katsushika-ku
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Kodaira
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Setagaya
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Tosima-ku
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Fukuoka
Country
Japan
Facility Name
Research Site
City
Kyoto
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

Study to Evaluate the Safety and Efficacy of Formoterol in a Daily Dose of 18 µg (9 µg Twice Daily) in Japanese Chronic Obstructive Pulmonary Disease (COPD) Patients

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