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

December 4, 2012 updated by: AstraZeneca

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
251

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Clinical Laboratory Test: Haematology -Erythrocytes
Time Frame: Baseline and week 52
Mean change from Baseline
Baseline and week 52
Clinical Laboratory Test: Haematology -Haemoglobin
Time Frame: Baseline and week 52
Change from baseline
Baseline and week 52
Clinical Laboratory Test: Haematology-Leucocytes
Time Frame: Baseline and week 52
Change from baseline
Baseline and week 52
Clinical Laboratory Test: Haematology-Platelet Count
Time Frame: Baseline and week 52
Change from baseline
Baseline and week 52
Clinical Laboratory Test: Haematology Eosinophils
Time Frame: baseline and week 52
Change from baseline
baseline and week 52
Clinical Laboratory Test: Haematology Basophil
Time Frame: Baseline and week 52
Change from baseline
Baseline and week 52
Clinical Laboratory Test: Haematology-Lymphocytes
Time Frame: Baseline and week 52
Change from baseline
Baseline and week 52
Clinical Laboratory Test: Haematology-Monocytes
Time Frame: Baseline and week 52
Change from baseline
Baseline and week 52
Clinical Laboratory Test: Haematology -Neutrophils
Time Frame: Baseline and week 52
Change from baseline
Baseline and week 52
Clinical Laboratory Test: Clinical Chemistry- S-Alanine Aminotransferase
Time Frame: Baseline and week 52
Change from baseline
Baseline and week 52
Clinical Laboratory Test: Clinical Chemistry-S-Aspartate Aminotransferase
Time Frame: Baseline and week 52
Change from baseline
Baseline and week 52
Clinical Laboratory Test: Clinical Chemistry-S-Alkaline Phosphatase (ALP)
Time Frame: Baseline and week 52
Change from baseline
Baseline and week 52
Clinical Laboratory Test: Clinical Chemistry-S-Creatinine
Time Frame: Baseline and week 52
Change from Baseline
Baseline and week 52
Clinical Laboratory Test: Clinical Chemistry-S-Total Bilirubin
Time Frame: Baseline and week 52
Change from baseline
Baseline and week 52
Clinical Laboratory Test: Clinical Chemistry-S-Sodium
Time Frame: Baseline and week 52
Change from baseline
Baseline and week 52
Clinical Laboratory Test: Clinical Chemistry-S-Potassium
Time Frame: Baseline and week 52
Change from baseline
Baseline and week 52
Clinical Laboratory Test: Clinical Chemistry-S- Calcium
Time Frame: Baseline and week 52
Change from baseline
Baseline and week 52
Clinical Laboratory Test: Clinical Chemistry-S-Albumin
Time Frame: Baseline and week 52
Change from baseline
Baseline and week 52
Clinical Laboratory Test: Clinical Chemistry-S-Total Protein
Time Frame: Baseline and week 52
Change from baseline
Baseline and week 52
Clinical Laboratory Test: Clinical Chemistry - S-Blood Urea Nitrogen (BUN)
Time Frame: Baseline and week 52
Change from baseline
Baseline and week 52
Vital Signs- Sitting SBP
Time Frame: Baseline and week 52
Change from baseline
Baseline and week 52
Vital Signs- Sitting DBP
Time Frame: Baseline and week 52
Change from baseline
Baseline and week 52
Vital Signs - Pulse Rate
Time Frame: Baseline and week 52
Change from baseline
Baseline and week 52
ECG Variables - Heart Rate
Time Frame: Baseline and week 52
Change from baseline
Baseline and week 52
ECG Variables - QT Interval
Time Frame: Baseline and week 52
Change from baseline
Baseline and week 52
ECG Variables - QTcB Interval
Time Frame: Baseline and week 52
Change from baseline
Baseline and week 52
ECG Variables QTcF Interval
Time Frame: Baseline and week 52
Change from baseline
Baseline and week 52
ECG Variables RR Interval
Time Frame: Baseline and week 52
Change from baseline
Baseline and week 52

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Forced Expiratory Volume in One Second (FEV1)
Time Frame: 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
Before randomization, 0, 4, 8, 17, 26, 34, 43 and 52 weeks after randomization
Forced Vital Capacity (FVC)
Time Frame: 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
Before randomization, 0, 4, 8, 17, 26, 34, 43 and 52 weeks after randomization
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
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)
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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.
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
Time Frame: 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.
Daily during 52-week randomization treatment
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
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
Time Frame: 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
Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 12, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 13, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 4, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D5122C00002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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