Evaluation of Efficacy and Safety of Formoterol in Patients With COPD Compared With Placebo in Patients in Japan, EU
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Registration Number
- NCT00628862
- Lead Sponsor
- AstraZeneca
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 613
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description F 4.5 bid Formoterol Turbuhaler® 4.5mg Formoterol 4.5 ug twice daily (bid) F 9.0 bid Formoterol Turbuhaler® 9 mg Formoterol 9.0 ug bid PBO Turbuhaler® placebo Placebo
- Primary Outcome Measures
Name Time Method Forced Expiratory Volume in 1 Second (FEV1; L) 60 Minutes Post-dose from baseline up to 12 weeks 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.
- Secondary Outcome Measures
Name Time Method FVC Pre-dose baseline at week 0 and pre-dose at weeks 4, 8 and 12 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
Forced Vital Capacity (FVC) 60 Minutes Post-dose from baseline up to 12 weeks 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
FEV1 Pre-dose baseline at week 0 and pre-dose at weeks 4, 8 and 12 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
FEV1 5 Minutes Post-dose baseline and 5 minutes anter first 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
FVC 5 Minutes Post-dose baseline and 5 minutes anter first 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
Change in Peak Expiratory Flow (PEF), Morning run-in period and 12 week 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
Change in Peak Expiratory Flow (PEF), Evening run-in period and 12 week 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
Change in Night-time Awakenings Due to Symptoms run-in period up to 12 weeks 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
Breathlessness run-in period up to 12 weeks 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
Cough run-in period up to 12 weeks 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
Use of Reliever Medication 12 weeks (end of run-in to last visit) 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
St George's Respiratory Questionnaire (SGRQ) 12 weeks (end of run-in to last visit) 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.
Trial Locations
- Locations (1)
Research Site
🇺🇦Kyiv, Ukraine