Evaluation of Efficacy and Safety of Formoterol in Patients With COPD Compared With Placebo in Patients in Japan, EU

Study Overview
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Brief Summary
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The purpose of this study is to show the efficacy and safety of formoterol for the maintenance treatment of patients with COPD compared with placebo in patients in Japan and in European countries during 12 weeks.

Official Title
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A 12-week, Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-national, Phase III, Efficacy and Safety Study of Inhaled Formoterol 4.5 μg and 9 μg Twice Daily in Japanese and European Patients With Chronic Obstructive Pulmonary Disease (COPD)

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Drug: Formoterol Turbuhaler® 4.5mg
* Drug: Formoterol Turbuhaler® 9 mg
* Drug: Turbuhaler® placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females aged above 40 with a clinical diagnosis of COPD and current COPD symptoms Current or previous smoker with a smoking history of 10 or more pack years Lung function parameters: FEV1/FVC < 70%, post-bronchodilator and post-bronchodilator FEV1 < 80% of predicted normal value Exclusion Criteria: History and/or current clinical diagnosis of asthma or atopic diseases such as allergic rhinitis Use of inhaled glucocorticosteroids within 4 weeks prior to Visit 2 Any relevant cardiovascular disorder as judged by the investigator or any current respiratory tract disorder other than COPD.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: F 4.5 bid<br>Formoterol 4.5 ug twice daily (bid) | Drug: Formoterol Turbuhaler® 4.5mg<br>* 4.5 mg inhaled twice daily<br>* Other names: Oxis;|
| Experimental: F 9.0 bid<br>Formoterol 9.0 ug bid | Drug: Formoterol Turbuhaler® 9 mg<br>* 9 mg inhaled twice daily<br>* Other names: Oxis;|
| Placebo Comparator: PBO<br>Placebo | Drug: Turbuhaler® placebo<br>* placebo inhaled twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced Expiratory Volume in 1 Second (FEV1; L) 60 Minutes Post-dose | FEV1 (expressed as litres [L]) is a spirometric measure of lung function. FEV1 was measured 60 minutes after administration of study drug. The results are expressed as a percentage in relation to the baseline value. | from baseline up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced Vital Capacity (FVC) 60 Minutes Post-dose | Forced Vital Capacity (FVC) is a spirometric measure of lung function. FVC was measured 60 minutes after administration of study drug. The results are expressed as a percentage in relation to the baseline value | from baseline up to 12 weeks | 
| FEV1 Pre-dose | Lung function (FEV1) was measured before administrations of the study drug (pre-dose). The results are expressed as a percentage of mean FEV1 over visists 4-6 in relation to the baseline (visit 3) value | baseline at week 0 and pre-dose at weeks 4, 8 and 12 | 
| FVC Pre-dose | Lung function (FVC) was measured before administrations of the study drug (pre-dose). The results are expressed as a percentage of mean FEV1 over visists 4-6 in relation to the baseline (visit 3) value | baseline at week 0 and pre-dose at weeks 4, 8 and 12 | 
| FEV1 5 Minutes Post-dose | Lung function (FEV1) was measured 5 minutes after the first dose of study drug. The results are expressed as a percentage in relation to the baseline value | baseline and 5 minutes anter first dose | 
| FVC 5 Minutes Post-dose | Lung function (FVC) was measured 5 minutes after the first dose of study drug, The results are expressed as a percentage in relation to the baseline value | baseline and 5 minutes anter first dose | 
| Change in Peak Expiratory Flow (PEF), Morning | Patients were asked to measure and record lung function (peak expiratory flow [PEF] measured in the morning). Average values over the last 10 days of the run-in period and the whole treatment period were calculated. The results are expressed as the change from the run-in period average value | run-in period and 12 week | 
| Change in Peak Expiratory Flow (PEF), Evening | Patients were asked to measure and record lung function (peak expiratory flow [PEF] measured in the evening). Average values over the last 10 days of the run-in period and the whole treatment period were calculated. The results are expressed as the change from the run-in period average value | run-in period and 12 week | 
| Change in Night-time Awakenings Due to Symptoms | Patients were asked to record the night-time awakenings due to symptoms (scored from 0-4 with 4 being the most severe). Period averages over the last 10 days of the run-in period and the whole treatment period were calculated. The results are expressed as the change from the run-in period average value | run-in period up to 12 weeks | 
| Breathlessness | Patients were asked to record breathlessness (scored from 0-4 with 4 being the most severe). Period averages over the last 10 days of the run-in period and the whole treatment period were calculated. The results are expressed as the change from the run-in period average value | run-in period up to 12 weeks | 
| Cough | Patients were asked to record cough (scored from 0-4 with 4 being the most severe). Period averages over the last 10 days of the run-in period and the whole treatment period were calculated. The results are expressed as the change from the run-in period average value | run-in period up to 12 weeks | 
| Use of Reliever Medication | Patients were asked to record reliever medication use. Period averages over the last 10 days of the run-in period and the whole treatment period were calculated. The results are expressed as the change from the run-in period average value | 12 weeks (end of run-in to last visit) | 
| St George's Respiratory Questionnaire (SGRQ) | Patients were asked to complete the St George's Respiratory Questionnaire (SGRQ). Subscale symptom score ranges from 0 to 100% and measures the effect of respiratory symptoms, frequency, and severity on quality of life. A score of 0 indicates the best possible status. Results are expressed as the change from baseline score with a decrease in score indicating improvement. | 12 weeks (end of run-in to last visit) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Obstructive Pulmonary Disease, COPD