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

Chronic Obstructive Pulmonary Disease Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01047553
• Other study ID #: D5122C00002
• Status: Completed
• Phase: Phase 3
• First received: January 12, 2010
• Last updated: December 4, 2012
• Start date: December 2009
• Est. completion date: July 2011

Study information

• Verified date: December 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and WelfareJapan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 251
• Est. completion date: July 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Formoterol (OT)
9 µg/dose, Inhaled, twice daily for 52 weeks

Locations

Country	Name	City	State
Japan	Research Site	Akita-shi	Akita
Japan	Research Site	AKO	Hyogo
Japan	Research Site	Bunkyo	Tokyo
Japan	Research Site	Chitose	Hokkaido
Japan	Research Site	Chuo	Tokyo
Japan	Research Site	Fujisawa	Kanagawa
Japan	Research Site	Fukuoka
Japan	Research Site	Hitachi	Ibaraki
Japan	Research Site	Kanazawa	Ishikawa
Japan	Research Site	Katsushika-ku	Tokyo
Japan	Research Site	Kawasaki-shi	Kanagawa
Japan	Research Site	Kobe-shi	Hyogo
Japan	Research Site	Kodaira	Tokyo
Japan	Research Site	Koshi	Kumamoto
Japan	Research Site	Kyoto
Japan	Research Site	Matsue	Shimane
Japan	Research Site	Moriguchi	Osaka
Japan	Research Site	Nagaoka	Niigata
Japan	Research Site	Nagoya	Aichi
Japan	Research Site	Obihiro	Hokkaido
Japan	Research Site	Saiki-shi	Oita
Japan	Research Site	Sakaide	Kagawa
Japan	Research Site	Sapporo	Hokkaido
Japan	Research Site	Setagaya	Tokyo
Japan	Research Site	Tosima-ku	Tokyo
Japan	Research Site	Tsukuba	Ibaraki
Japan	Research Site	Yokohama	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Laboratory Test: Haematology -Erythrocytes	Mean change from Baseline	Baseline and week 52	Yes
Primary	Clinical Laboratory Test: Haematology -Haemoglobin	Change from baseline	Baseline and week 52	Yes
Primary	Clinical Laboratory Test: Haematology-Leucocytes	Change from baseline	Baseline and week 52	Yes
Primary	Clinical Laboratory Test: Haematology-Platelet Count	Change from baseline	Baseline and week 52	Yes
Primary	Clinical Laboratory Test: Haematology Eosinophils	Change from baseline	baseline and week 52	Yes
Primary	Clinical Laboratory Test: Haematology Basophil	Change from baseline	Baseline and week 52	Yes
Primary	Clinical Laboratory Test: Haematology-Lymphocytes	Change from baseline	Baseline and week 52	Yes
Primary	Clinical Laboratory Test: Haematology-Monocytes	Change from baseline	Baseline and week 52	Yes
Primary	Clinical Laboratory Test: Haematology -Neutrophils	Change from baseline	Baseline and week 52	Yes
Primary	Clinical Laboratory Test: Clinical Chemistry- S-Alanine Aminotransferase	Change from baseline	Baseline and week 52	Yes
Primary	Clinical Laboratory Test: Clinical Chemistry-S-Aspartate Aminotransferase	Change from baseline	Baseline and week 52	Yes
Primary	Clinical Laboratory Test: Clinical Chemistry-S-Alkaline Phosphatase (ALP)	Change from baseline	Baseline and week 52	Yes
Primary	Clinical Laboratory Test: Clinical Chemistry-S-Creatinine	Change from Baseline	Baseline and week 52	Yes
Primary	Clinical Laboratory Test: Clinical Chemistry-S-Total Bilirubin	Change from baseline	Baseline and week 52	Yes
Primary	Clinical Laboratory Test: Clinical Chemistry-S-Sodium	Change from baseline	Baseline and week 52	Yes
Primary	Clinical Laboratory Test: Clinical Chemistry-S-Potassium	Change from baseline	Baseline and week 52	Yes
Primary	Clinical Laboratory Test: Clinical Chemistry-S- Calcium	Change from baseline	Baseline and week 52	Yes
Primary	Clinical Laboratory Test: Clinical Chemistry-S-Albumin	Change from baseline	Baseline and week 52	Yes
Primary	Clinical Laboratory Test: Clinical Chemistry-S-Total Protein	Change from baseline	Baseline and week 52	Yes
Primary	Clinical Laboratory Test: Clinical Chemistry - S-Blood Urea Nitrogen (BUN)	Change from baseline	Baseline and week 52	Yes
Primary	Vital Signs- Sitting SBP	Change from baseline	Baseline and week 52	Yes
Primary	Vital Signs- Sitting DBP	Change from baseline	Baseline and week 52	Yes
Primary	Vital Signs - Pulse Rate	Change from baseline	Baseline and week 52	Yes
Primary	ECG Variables - Heart Rate	Change from baseline	Baseline and week 52	Yes
Primary	ECG Variables - QT Interval	Change from baseline	Baseline and week 52	Yes
Primary	ECG Variables - QTcB Interval	Change from baseline	Baseline and week 52	Yes
Primary	ECG Variables QTcF Interval	Change from baseline	Baseline and week 52	Yes
Primary	ECG Variables RR Interval	Change from baseline	Baseline and week 52	Yes
Secondary	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	Before randomization, 0, 4, 8, 17, 26, 34, 43 and 52 weeks after randomization	No
Secondary	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	Before randomization, 0, 4, 8, 17, 26, 34, 43 and 52 weeks after randomization	No
Secondary	Morning Peak Expiratory Flow(PEF)	The change from Run-in period average to Treatment period average for each treatment group	Daily during run-in period (14 - 18 days before Randomisation visit)and daily during 52-week randomization treatment	No
Secondary	Evening Peak Expiratory Flow (PEF)	The change from Run-in period average to Treatment period average for each treatment group	Daily during run-in period (14 - 18 days before Randomisation visit) and daily during 52-week randomization treatment	No
Secondary	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	Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment	No
Secondary	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	Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment	No
Secondary	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	Daily during run-in period (14 - 18 days before Randomisation visit) and daily during 52-week randomization treatment	No
Secondary	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.	Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment	No
Secondary	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.	Daily during 52-week randomization treatment	No
Secondary	Use of SABA (Salbutamol) as Reliever Medication	The change from Run-in period average to Treatment period average for each treatment group.	Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment	No
Secondary	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	Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment	No