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 - Full Text View

Purpose

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).

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease	Drug: Formoterol (OT)	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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)

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease) Potassium

Drug Information available for: Formoterol fumarate Formoterol Arformoterol Tartrate

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Forced Expiratory Volume in One Second (FEV1) [ Time Frame: Before randomization, 0, 4, 8, 17, 26, 34, 43 and 52 weeks after randomization ] [ Designated as safety issue: No ]
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) [ Time Frame: Before randomization, 0, 4, 8, 17, 26, 34, 43 and 52 weeks after randomization ] [ Designated as safety issue: No ]
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) [ Time Frame: Daily during run-in period (14 - 18 days before Randomisation visit)and daily during 52-week randomization treatment ] [ Designated as safety issue: No ]
The change from Run-in period average to Treatment period average for each treatment group
Evening Peak Expiratory Flow (PEF) [ Time Frame: Daily during run-in period (14 - 18 days before Randomisation visit) and daily during 52-week randomization treatment ] [ Designated as safety issue: No ]
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 [ Time Frame: Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment ] [ Designated as safety issue: No ]
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 [ Time Frame: Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment ] [ Designated as safety issue: No ]
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 [ Time Frame: Daily during run-in period (14 - 18 days before Randomisation visit) and daily during 52-week randomization treatment ] [ Designated as safety issue: No ]
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 [ Time Frame: Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment ] [ Designated as safety issue: No ]
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 [ Time Frame: Daily during 52-week randomization treatment ] [ Designated as safety issue: No ]
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 [ Time Frame: Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment ] [ Designated as safety issue: No ]
The change from Run-in period average to Treatment period average for each treatment group.
St George's Respiratory Questionnaire (SGRQ) Total Score [ Time Frame: Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment ] [ Designated as safety issue: No ]
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

Enrollment:	251
Study Start Date:	December 2009
Study Completion Date:	July 2011
Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Formoterol 9 μg/dose	Drug: Formoterol (OT) 9 μg/dose, Inhaled, twice daily for 52 weeks Other Name: Oxis Turbuhaler®

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01047553

Locations

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

Sponsors and Collaborators

AstraZeneca

More Information

No publications provided

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT01047553 History of Changes
Other Study ID Numbers:	D5122C00002
Study First Received:	January 12, 2010
Results First Received:	July 18, 2012
Last Updated:	December 4, 2012
Health Authority:	Japan: Ministry of Health, Labor and Welfare Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by AstraZeneca:

Chronic Obstructive Pulmonary Disease
COPD
Japanese
Phase 3

Safety
OT
Oxis

Additional relevant MeSH terms:

Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Formoterol
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013