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

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)

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 Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: Formoterol (OT)

• Study Type: Interventional
• Enrollment (Actual): 251
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Formoterol 9 μg/dose	Drug: Formoterol (OT); 9 μg/dose, Inhaled, twice daily for 52 weeks; Other Names: Oxis Turbuhaler®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Laboratory Test: Haematology -Erythrocytes	Mean change from Baseline	Baseline and week 52
Clinical Laboratory Test: Haematology -Haemoglobin	Change from baseline	Baseline and week 52
Clinical Laboratory Test: Haematology-Leucocytes	Change from baseline	Baseline and week 52
Clinical Laboratory Test: Haematology-Platelet Count	Change from baseline	Baseline and week 52
Clinical Laboratory Test: Haematology Eosinophils	Change from baseline	baseline and week 52
Clinical Laboratory Test: Haematology Basophil	Change from baseline	Baseline and week 52
Clinical Laboratory Test: Haematology-Lymphocytes	Change from baseline	Baseline and week 52
Clinical Laboratory Test: Haematology-Monocytes	Change from baseline	Baseline and week 52
Clinical Laboratory Test: Haematology -Neutrophils	Change from baseline	Baseline and week 52
Clinical Laboratory Test: Clinical Chemistry- S-Alanine Aminotransferase	Change from baseline	Baseline and week 52
Clinical Laboratory Test: Clinical Chemistry-S-Aspartate Aminotransferase	Change from baseline	Baseline and week 52
Clinical Laboratory Test: Clinical Chemistry-S-Alkaline Phosphatase (ALP)	Change from baseline	Baseline and week 52
Clinical Laboratory Test: Clinical Chemistry-S-Creatinine	Change from Baseline	Baseline and week 52
Clinical Laboratory Test: Clinical Chemistry-S-Total Bilirubin	Change from baseline	Baseline and week 52
Clinical Laboratory Test: Clinical Chemistry-S-Sodium	Change from baseline	Baseline and week 52
Clinical Laboratory Test: Clinical Chemistry-S-Potassium	Change from baseline	Baseline and week 52
Clinical Laboratory Test: Clinical Chemistry-S- Calcium	Change from baseline	Baseline and week 52
Clinical Laboratory Test: Clinical Chemistry-S-Albumin	Change from baseline	Baseline and week 52
Clinical Laboratory Test: Clinical Chemistry-S-Total Protein	Change from baseline	Baseline and week 52
Clinical Laboratory Test: Clinical Chemistry - S-Blood Urea Nitrogen (BUN)	Change from baseline	Baseline and week 52
Vital Signs- Sitting SBP	Change from baseline	Baseline and week 52
Vital Signs- Sitting DBP	Change from baseline	Baseline and week 52
Vital Signs - Pulse Rate	Change from baseline	Baseline and week 52
ECG Variables - Heart Rate	Change from baseline	Baseline and week 52
ECG Variables - QT Interval	Change from baseline	Baseline and week 52
ECG Variables - QTcB Interval	Change from baseline	Baseline and week 52
ECG Variables QTcF Interval	Change from baseline	Baseline and week 52
ECG Variables RR Interval	Change from baseline	Baseline and week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: January 12, 2010
• First Submitted That Met QC Criteria: January 12, 2010
• First Posted (Estimate): January 13, 2010

Study Record Updates

• Last Update Posted (Estimate): January 4, 2013
• Last Update Submitted That Met QC Criteria: December 4, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: Safety; COPD; OT; Japanese; Chronic Obstructive Pulmonary Disease; Phase 3; Oxis
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Formoterol Fumarate
• Other Study ID Numbers: D5122C00002