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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

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ClinicalTrials.gov Identifier: NCT01047553
Recruitment Status : Completed
First Posted : January 13, 2010
Results First Posted : January 4, 2013
Last Update Posted : January 4, 2013
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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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).

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: Formoterol (OT) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 251 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : December 2009
Actual Primary Completion Date : January 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

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


Outcome Measures
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Primary Outcome Measures :
  1. Clinical Laboratory Test: Haematology -Erythrocytes [ Time Frame: Baseline and week 52 ]
    Mean change from Baseline

  2. Clinical Laboratory Test: Haematology -Haemoglobin [ Time Frame: Baseline and week 52 ]
    Change from baseline

  3. Clinical Laboratory Test: Haematology-Leucocytes [ Time Frame: Baseline and week 52 ]
    Change from baseline

  4. Clinical Laboratory Test: Haematology-Platelet Count [ Time Frame: Baseline and week 52 ]
    Change from baseline

  5. Clinical Laboratory Test: Haematology Eosinophils [ Time Frame: baseline and week 52 ]
    Change from baseline

  6. Clinical Laboratory Test: Haematology Basophil [ Time Frame: Baseline and week 52 ]
    Change from baseline

  7. Clinical Laboratory Test: Haematology-Lymphocytes [ Time Frame: Baseline and week 52 ]
    Change from baseline

  8. Clinical Laboratory Test: Haematology-Monocytes [ Time Frame: Baseline and week 52 ]
    Change from baseline

  9. Clinical Laboratory Test: Haematology -Neutrophils [ Time Frame: Baseline and week 52 ]
    Change from baseline

  10. Clinical Laboratory Test: Clinical Chemistry- S-Alanine Aminotransferase [ Time Frame: Baseline and week 52 ]
    Change from baseline

  11. Clinical Laboratory Test: Clinical Chemistry-S-Aspartate Aminotransferase [ Time Frame: Baseline and week 52 ]
    Change from baseline

  12. Clinical Laboratory Test: Clinical Chemistry-S-Alkaline Phosphatase (ALP) [ Time Frame: Baseline and week 52 ]
    Change from baseline

  13. Clinical Laboratory Test: Clinical Chemistry-S-Creatinine [ Time Frame: Baseline and week 52 ]
    Change from Baseline

  14. Clinical Laboratory Test: Clinical Chemistry-S-Total Bilirubin [ Time Frame: Baseline and week 52 ]
    Change from baseline

  15. Clinical Laboratory Test: Clinical Chemistry-S-Sodium [ Time Frame: Baseline and week 52 ]
    Change from baseline

  16. Clinical Laboratory Test: Clinical Chemistry-S-Potassium [ Time Frame: Baseline and week 52 ]
    Change from baseline

  17. Clinical Laboratory Test: Clinical Chemistry-S- Calcium [ Time Frame: Baseline and week 52 ]
    Change from baseline

  18. Clinical Laboratory Test: Clinical Chemistry-S-Albumin [ Time Frame: Baseline and week 52 ]
    Change from baseline

  19. Clinical Laboratory Test: Clinical Chemistry-S-Total Protein [ Time Frame: Baseline and week 52 ]
    Change from baseline

  20. Clinical Laboratory Test: Clinical Chemistry - S-Blood Urea Nitrogen (BUN) [ Time Frame: Baseline and week 52 ]
    Change from baseline

  21. Vital Signs- Sitting SBP [ Time Frame: Baseline and week 52 ]
    Change from baseline

  22. Vital Signs- Sitting DBP [ Time Frame: Baseline and week 52 ]
    Change from baseline

  23. Vital Signs - Pulse Rate [ Time Frame: Baseline and week 52 ]
    Change from baseline

  24. ECG Variables - Heart Rate [ Time Frame: Baseline and week 52 ]
    Change from baseline

  25. ECG Variables - QT Interval [ Time Frame: Baseline and week 52 ]
    Change from baseline

  26. ECG Variables - QTcB Interval [ Time Frame: Baseline and week 52 ]
    Change from baseline

  27. ECG Variables QTcF Interval [ Time Frame: Baseline and week 52 ]
    Change from baseline

  28. ECG Variables RR Interval [ Time Frame: Baseline and week 52 ]
    Change from baseline


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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.

  9. 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.

  10. 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.

  11. 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


Eligibility Criteria
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Layout table for eligibility information
Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01047553


Locations
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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
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Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01047553    
Other Study ID Numbers: D5122C00002
First Posted: January 13, 2010    Key Record Dates
Results First Posted: January 4, 2013
Last Update Posted: January 4, 2013
Last Verified: December 2012
Keywords provided by AstraZeneca:
Chronic Obstructive Pulmonary Disease
COPD
Japanese
Phase 3
 Safety
OT
Oxis
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Formoterol Fumarate
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action