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
- Registration Number
- NCT01047553
- Lead Sponsor
- AstraZeneca
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 251
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Formoterol (OT) Formoterol 9 μg/dose
- Primary Outcome Measures
Name Time Method Clinical Laboratory Test: Haematology -Erythrocytes Baseline and week 52 Mean change from Baseline
Clinical Laboratory Test: Haematology -Haemoglobin Baseline and week 52 Change from baseline
Clinical Laboratory Test: Haematology-Leucocytes Baseline and week 52 Change from baseline
Clinical Laboratory Test: Haematology-Platelet Count Baseline and week 52 Change from baseline
Clinical Laboratory Test: Haematology Eosinophils baseline and week 52 Change from baseline
Clinical Laboratory Test: Haematology Basophil Baseline and week 52 Change from baseline
Clinical Laboratory Test: Haematology-Lymphocytes Baseline and week 52 Change from baseline
Clinical Laboratory Test: Haematology-Monocytes Baseline and week 52 Change from baseline
Clinical Laboratory Test: Haematology -Neutrophils Baseline and week 52 Change from baseline
Clinical Laboratory Test: Clinical Chemistry- S-Alanine Aminotransferase Baseline and week 52 Change from baseline
Clinical Laboratory Test: Clinical Chemistry-S-Aspartate Aminotransferase Baseline and week 52 Change from baseline
Clinical Laboratory Test: Clinical Chemistry-S-Alkaline Phosphatase (ALP) Baseline and week 52 Change from baseline
Clinical Laboratory Test: Clinical Chemistry-S-Creatinine Baseline and week 52 Change from Baseline
Clinical Laboratory Test: Clinical Chemistry-S-Total Bilirubin Baseline and week 52 Change from baseline
Clinical Laboratory Test: Clinical Chemistry-S-Sodium Baseline and week 52 Change from baseline
Clinical Laboratory Test: Clinical Chemistry-S-Potassium Baseline and week 52 Change from baseline
Clinical Laboratory Test: Clinical Chemistry-S- Calcium Baseline and week 52 Change from baseline
Clinical Laboratory Test: Clinical Chemistry-S-Albumin Baseline and week 52 Change from baseline
Clinical Laboratory Test: Clinical Chemistry-S-Total Protein Baseline and week 52 Change from baseline
Clinical Laboratory Test: Clinical Chemistry - S-Blood Urea Nitrogen (BUN) Baseline and week 52 Change from baseline
Vital Signs- Sitting SBP Baseline and week 52 Change from baseline
Vital Signs- Sitting DBP Baseline and week 52 Change from baseline
Vital Signs - Pulse Rate Baseline and week 52 Change from baseline
ECG Variables - Heart Rate Baseline and week 52 Change from baseline
ECG Variables - QT Interval Baseline and week 52 Change from baseline
ECG Variables - QTcB Interval Baseline and week 52 Change from baseline
ECG Variables QTcF Interval Baseline and week 52 Change from baseline
ECG Variables RR Interval Baseline and week 52 Change from baseline
- Secondary Outcome Measures
Name Time Method Forced Expiratory Volume in One Second (FEV1) Before randomization, 0, 4, 8, 17, 26, 34, 43 and 52 weeks after randomization 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) 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
Morning Peak Expiratory Flow(PEF) Daily during run-in period (14 - 18 days before Randomisation visit)and daily during 52-week randomization treatment The change from Run-in period average to Treatment period average for each treatment group
Evening Peak Expiratory Flow (PEF) Daily during run-in period (14 - 18 days before Randomisation visit) and daily during 52-week randomization treatment 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 Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment 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 Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment 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 Daily during run-in period (14 - 18 days before Randomisation visit) and daily during 52-week randomization treatment 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 Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment 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 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 was presented here.
Use of SABA (Salbutamol) as Reliever Medication Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment The change from Run-in period average to Treatment period average for each treatment group.
St George's Respiratory Questionnaire (SGRQ) Total Score Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment 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
Trial Locations
- Locations (1)
Research Site
🇯🇵Kyoto, Japan