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Completed

NCT Number: NCT01047553

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

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).

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Nagoya, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Formoterol (OT)

Drug

9 μg/dose, Inhaled, twice daily for 52 weeks

Other names: Oxis Turbuhaler®

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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)

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jan 13, 2010
Registry last updated
Jan 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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