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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
251
9 μg/dose, Inhaled, twice daily for 52 weeks
Research Site
Nagoya, Aichi-ken, Japan
Research Site
Akita, Akita, Japan
Clinical Laboratory Test: Haematology -Erythrocytes
Mean change from Baseline
Time frame: Baseline and week 52
Clinical Laboratory Test: Haematology -Haemoglobin
Change from baseline
Time frame: Baseline and week 52
Clinical Laboratory Test: Haematology-Leucocytes
Change from baseline
Time frame: Baseline and week 52
Clinical Laboratory Test: Haematology-Platelet Count
Change from baseline
Time frame: Baseline and week 52
Clinical Laboratory Test: Haematology Eosinophils
Change from baseline
Time frame: baseline and week 52
Clinical Laboratory Test: Haematology Basophil
Change from baseline
Time frame: Baseline and week 52
Clinical Laboratory Test: Haematology-Lymphocytes
Change from baseline
Time frame: Baseline and week 52
Clinical Laboratory Test: Haematology-Monocytes
Change from baseline
Time frame: Baseline and week 52
Clinical Laboratory Test: Haematology -Neutrophils
Change from baseline
Time frame: Baseline and week 52
Clinical Laboratory Test: Clinical Chemistry- S-Alanine Aminotransferase
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Research Site
Fukuoka, Fukuoka, Japan
Research Site
Chitose, Hokkaido, Japan
Research Site
Obihiro, Hokkaido, Japan
Research Site
Sapporo, Hokkaido, Japan
Research Site
Ako, Hyōgo, Japan
Research Site
Kobe, Hyōgo, Japan
Research Site
Hitachi, Ibaraki, Japan
Research Site
Tsukuba, Ibaraki, Japan
...and 17 more locations
Change from baseline
Time frame: Baseline and week 52
Clinical Laboratory Test: Clinical Chemistry-S-Aspartate Aminotransferase
Change from baseline
Time frame: Baseline and week 52
Clinical Laboratory Test: Clinical Chemistry-S-Alkaline Phosphatase (ALP)
Change from baseline
Time frame: Baseline and week 52
Clinical Laboratory Test: Clinical Chemistry-S-Creatinine
Change from Baseline
Time frame: Baseline and week 52
Clinical Laboratory Test: Clinical Chemistry-S-Total Bilirubin
Change from baseline
Time frame: Baseline and week 52
Clinical Laboratory Test: Clinical Chemistry-S-Sodium
Change from baseline
Time frame: Baseline and week 52
Clinical Laboratory Test: Clinical Chemistry-S-Potassium
Change from baseline
Time frame: Baseline and week 52
Clinical Laboratory Test: Clinical Chemistry-S- Calcium
Change from baseline
Time frame: Baseline and week 52
Clinical Laboratory Test: Clinical Chemistry-S-Albumin
Change from baseline
Time frame: Baseline and week 52
Clinical Laboratory Test: Clinical Chemistry-S-Total Protein
Change from baseline
Time frame: Baseline and week 52
Clinical Laboratory Test: Clinical Chemistry - S-Blood Urea Nitrogen (BUN)
Change from baseline
Time frame: Baseline and week 52
Vital Signs- Sitting SBP
Change from baseline
Time frame: Baseline and week 52
Vital Signs- Sitting DBP
Change from baseline
Time frame: Baseline and week 52
Vital Signs - Pulse Rate
Change from baseline
Time frame: Baseline and week 52
ECG Variables - Heart Rate
Change from baseline
Time frame: Baseline and week 52
ECG Variables - QT Interval
Change from baseline
Time frame: Baseline and week 52
ECG Variables - QTcB Interval
Change from baseline
Time frame: Baseline and week 52
ECG Variables QTcF Interval
Change from baseline
Time frame: Baseline and week 52
ECG Variables RR Interval
Change from baseline
Time frame: Baseline and week 52
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
Time frame: Before randomization, 0, 4, 8, 17, 26, 34, 43 and 52 weeks after randomization
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
Time frame: Before randomization, 0, 4, 8, 17, 26, 34, 43 and 52 weeks after randomization
Morning Peak Expiratory Flow(PEF)
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
Evening Peak Expiratory Flow (PEF)
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
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
Time frame: Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment
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
Time frame: Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment
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
Time frame: Daily during run-in period (14 - 18 days before Randomisation visit) and daily during 52-week randomization treatment
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.
Time frame: Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment
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.
Time frame: Daily during 52-week randomization treatment
Use of SABA (Salbutamol) as Reliever Medication
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
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
Time frame: Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment