Clinical trial NCT01047553: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease
COPD
Japanese
Phase 3
Safety
OT
Oxis
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-01-13
Enrollment: 251
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Clinical Laboratory Test: Haematology -Erythrocytes
timeFrame: Baseline and week 52
measure: Clinical Laboratory Test: Haematology -Haemoglobin
timeFrame: Baseline and week 52
measure: Clinical Laboratory Test: Haematology-Leucocytes
timeFrame: Baseline and week 52
measure: Clinical Laboratory Test: Haematology-Platelet Count
timeFrame: Baseline and week 52
measure: Clinical Laboratory Test: Haematology Eosinophils
timeFrame: baseline and week 52
measure: Clinical Laboratory Test: Haematology Basophil
timeFrame: Baseline and week 52
measure: Clinical Laboratory Test: Haematology-Lymphocytes
timeFrame: Baseline and week 52
measure: Clinical Laboratory Test: Haematology-Monocytes
timeFrame: Baseline and week 52
measure: Clinical Laboratory Test: Haematology -Neutrophils
timeFrame: Baseline and week 52
measure: Clinical Laboratory Test: Clinical Chemistry- S-Alanine Aminotransferase
timeFrame: Baseline and week 52
measure: Clinical Laboratory Test: Clinical Chemistry-S-Aspartate Aminotransferase
timeFrame: Baseline and week 52
measure: Clinical Laboratory Test: Clinical Chemistry-S-Alkaline Phosphatase (ALP)
timeFrame: Baseline and week 52
measure: Clinical Laboratory Test: Clinical Chemistry-S-Creatinine
timeFrame: Baseline and week 52
measure: Clinical Laboratory Test: Clinical Chemistry-S-Total Bilirubin
timeFrame: Baseline and week 52
measure: Clinical Laboratory Test: Clinical Chemistry-S-Sodium
timeFrame: Baseline and week 52
measure: Clinical Laboratory Test: Clinical Chemistry-S-Potassium
timeFrame: Baseline and week 52
measure: Clinical Laboratory Test: Clinical Chemistry-S- Calcium
timeFrame: Baseline and week 52
measure: Clinical Laboratory Test: Clinical Chemistry-S-Albumin
timeFrame: Baseline and week 52
measure: Clinical Laboratory Test: Clinical Chemistry-S-Total Protein
timeFrame: Baseline and week 52
measure: Clinical Laboratory Test: Clinical Chemistry - S-Blood Urea Nitrogen (BUN)
timeFrame: Baseline and week 52
measure: Vital Signs- Sitting SBP
timeFrame: Baseline and week 52
measure: Vital Signs- Sitting DBP
timeFrame: Baseline and week 52
measure: Vital Signs - Pulse Rate
timeFrame: Baseline and week 52
measure: ECG Variables - Heart Rate
timeFrame: Baseline and week 52
measure: ECG Variables - QT Interval
timeFrame: Baseline and week 52
measure: ECG Variables - QTcB Interval
timeFrame: Baseline and week 52
measure: ECG Variables QTcF Interval
timeFrame: Baseline and week 52
measure: ECG Variables RR Interval
timeFrame: Baseline and week 52
Secondary outcomes:
measure: Forced Expiratory Volume in One Second (FEV1)
timeFrame: Before randomization, 0, 4, 8, 17, 26, 34, 43 and 52 weeks after randomization
measure: Forced Vital Capacity (FVC)
timeFrame: Before randomization, 0, 4, 8, 17, 26, 34, 43 and 52 weeks after randomization
measure: Morning Peak Expiratory Flow(PEF)
timeFrame: Daily during run-in period (14 - 18 days before Randomisation visit)and daily during 52-week randomization treatment
measure: Evening Peak Expiratory Flow (PEF)
timeFrame: Daily during run-in period (14 - 18 days before Randomisation visit) and daily during 52-week randomization treatment
measure: Night-time Awakening Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms
timeFrame: Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment
measure: Daytime Breathlessness Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms
timeFrame: Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment
measure: Daytime Cough Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms
timeFrame: Daily during run-in period (14 - 18 days before Randomisation visit) and daily during 52-week randomization treatment
measure: Total Chronic Obstructive Pulmonary Disease (COPD) Symptom Score
timeFrame: Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment
measure: Number of COPD Exacerbations Over the Treatment Period
timeFrame: Daily during 52-week randomization treatment
measure: Use of SABA (Salbutamol) as Reliever Medication
timeFrame: Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment
measure: St George's Respiratory Questionnaire (SGRQ) Total Score
timeFrame: Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Research Site
state: Aichi
city: Akita-shi
country: Japan
facility: Research Site
state: Akita
city: Chitose
country: Japan
facility: Research Site
state: Hokkaido
city: Obihiro
country: Japan
facility: Research Site
state: Hokkaido
city: Sapporo
country: Japan
facility: Research Site
state: Hokkaido
city: AKO
country: Japan
facility: Research Site
state: Hyogo
city: Kobe-shi
country: Japan
facility: Research Site
state: Hyogo
city: Hitachi
country: Japan
facility: Research Site
state: Ibaraki
city: Tsukuba
country: Japan
facility: Research Site
state: Ibaraki
city: Kanazawa
country: Japan
facility: Research Site
state: Ishikawa
city: Sakaide
country: Japan
facility: Research Site
state: Kagawa
city: Fujisawa
country: Japan
facility: Research Site
state: Kanagawa
city: Kawasaki-shi
country: Japan
facility: Research Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Research Site
state: Kanagawa
city: Koshi
country: Japan
facility: Research Site
state: Kumamoto
city: Nagaoka
country: Japan
facility: Research Site
state: Niigata
city: Saiki-shi
country: Japan
facility: Research Site
state: Oita
city: Moriguchi
country: Japan
facility: Research Site
state: Osaka
city: Matsue
country: Japan
facility: Research Site
state: Shimane
city: Bunkyo
country: Japan
facility: Research Site
state: Tokyo
city: Chuo
country: Japan
facility: Research Site
state: Tokyo
city: Katsushika-ku
country: Japan
facility: Research Site
state: Tokyo
city: Kodaira
country: Japan
facility: Research Site
state: Tokyo
city: Setagaya
country: Japan
facility: Research Site
state: Tokyo
city: Tosima-ku
country: Japan
facility: Research Site
state: Tokyo
city: Fukuoka
country: Japan
facility: Research Site
city: Kyoto
country: Japan
facility: Research Site
Study officials:
References: