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 has been completed.

Sponsor:

Information provided by (Responsible Party):

AstraZeneca

ClinicalTrials.gov Identifier:

NCT01047553

First received: January 12, 2010

Last updated: December 4, 2012

Last verified: December 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	January 12, 2010
Last Updated Date	December 4, 2012
Start Date ^ICMJE	December 2009
Primary Completion Date	January 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 4, 2012)	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
Original Primary Outcome Measures ^ICMJE (submitted: January 12, 2010)	To investigate safety of formoterol and standard COPD treatment in a Japanese population of moderate to severe COPD patients treated for 52 weeks by means of adverse events (AEs), vital signs, laboratory variables, and ECG [ Time Frame: 52 Weeks ] [ Designated as safety issue: Yes ]
Change History	Complete list of historical versions of study NCT01047553 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 4, 2012)	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
Original Secondary Outcome Measures ^ICMJE (submitted: January 12, 2010)	To investigate the long-term efficacy profile of formoterol treatment in patients treated for 52 weeks by means of lung function tests, COPD symptoms, use of rescue medication, SGRQ, and number of exacerbations [ Time Frame: 52 Weeks ] [ Designated as safety issue: Yes ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	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
Official Title ^ICMJE	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)
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).
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Chronic Obstructive Pulmonary Disease
Intervention ^ICMJE	Drug: Formoterol (OT) 9 μg/dose, Inhaled, twice daily for 52 weeks Other Name: Oxis Turbuhaler®
Study Arm (s)	Experimental: 1 Formoterol 9 μg/dose Intervention: Drug: Formoterol (OT)
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	251
Completion Date	July 2011
Primary Completion Date	January 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	40 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Japan

Administrative Information
NCT Number ^ICMJE	NCT01047553
Other Study ID Numbers ^ICMJE	D5122C00002
Has Data Monitoring Committee	Yes
Responsible Party	AstraZeneca
Study Sponsor ^ICMJE	AstraZeneca
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	AstraZeneca
Verification Date	December 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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