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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT no 2007-003999-19 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| F 4.5 bid | Experimental | Formoterol 4.5 ug twice daily (bid) |
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| F 9.0 bid | Experimental | Formoterol 9.0 ug bid |
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| PBO | Placebo Comparator | Placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Formoterol Turbuhaler® 4.5mg | Drug | 4.5 mg inhaled twice daily |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lars-Goran Carlsson, MD | AstraZeneca R&D Lund, Sweden | Study Director |
| Miron A Bogdan, MD | Clinica Medic Or, Calea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Gabrovo | Bulgaria | ||||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22085439 | Derived | Bogdan MA, Aizawa H, Fukuchi Y, Mishima M, Nishimura M, Ichinose M. Efficacy and safety of inhaled formoterol 4.5 and 9 mug twice daily in Japanese and European COPD patients: phase III study results. BMC Pulm Med. 2011 Nov 15;11:51. doi: 10.1186/1471-2466-11-51. |
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Outpatients, male or female aged ≥ 40 years with moderate to severe chronic obstructive pulmonary disease (COPD). 766 subjects enrolled; 153 excluded: 96 for incorrect enrollment, 17 for adverse events, 32 for voluntary discontinuation, 1 for non-compliance with protocol, 7 for other reasons. 613 were randomised.
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| ID | Title | Description |
|---|---|---|
| FG000 | Formoterol 4.5 Bid | Formoterol 4.5 ug bid |
| FG001 | Formoterol 9.0 Bid | Formoterol 9.0 ug bid |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Formoterol Turbuhaler® 9 mg | Drug | 9 mg inhaled twice daily |
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| Turbuhaler® placebo | Drug | placebo inhaled twice daily |
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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) |
| Lovech |
| Bulgaria |
| Research Site | Pleven | Bulgaria |
| Research Site | Rousse | Bulgaria |
| Research Site | Sofia | Bulgaria |
| Research Site | Stara Zagora | Bulgaria |
| Research Site | Troyan Municipality | Bulgaria |
| Research Site | Varna | Bulgaria |
| Research Site | Nagoya | Aichi-ken | Japan |
| Research Site | Seto | Aichi-ken | Japan |
| Research Site | Noda | Chiba | Japan |
| Research Site | Touon | Ehime | Japan |
| Research Site | Yanagawa | Fukuoka | Japan |
| Research Site | Ōta | Gunma | Japan |
| Research Site | Ōwa | Gunma | Japan |
| Research Site | Hiroshima | Hiroshima | Japan |
| Research Site | Asahikawa | Hokkaido | Japan |
| Research Site | Chitose | Hokkaido | Japan |
| Research Site | Obihiro | Hokkaido | Japan |
| Research Site | Sapporo | Hokkaido | Japan |
| Research Site | Tomakomai | Hokkaido | Japan |
| Research Site | Yabu | Hyōgo | Japan |
| Research Site | Naka-gun | Ibaraki | Japan |
| Research Site | Morioka | Iwate | Japan |
| Research Site | Kagoshima | Kagoshima-ken | Japan |
| Research Site | Kawasaki | Kangawa | Japan |
| Research Site | Kochi | Kochi | Japan |
| Research Site | Kyoto | Kyoto | Japan |
| Research Site | Sendai | Miyagi | Japan |
| Research Site | Katano | Osaka | Japan |
| Research Site | Kishiwada | Osaka | Japan |
| Research Site | Osaka | Osaka | Japan |
| Research Site | Takatsuiki | Osaka | Japan |
| Research Site | Chiyoda City | Tokyo | Japan |
| Research Site | Wakayama | Wakayama | Japan |
| Research Site | Ube | Yamaguchi | Japan |
| Research Site | Deva | Hunedoara County | Romania |
| Research Site | Bucharest | Romania |
| Research Site | Constanța | Romania |
| Research Site | Iași | Romania |
| Research Site | Kazan' | Russia |
| Research Site | Moscow | Russia |
| Research Site | Saint Petersburg | Russia |
| Research Site | Dnipropetrovsk | Ukraine |
| Research Site | Donetsk | Ukraine |
| Research Site | Kharkiv | Ukraine |
| Research Site | Kyiv | Ukraine |
| FG002 |
| Placebo |
Placebo |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Formoterol 4.5 Bid | Formoterol 4.5 ug bid |
| BG001 | Formoterol 9.0 Bid | Formoterol 9.0 ug bid |
| BG002 | Placebo | Placebo |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Geometric Mean | Full Range | percent of baseline | from baseline up to 12 weeks |
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| Secondary | 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 | Posted | Geometric Mean | Full Range | percent of baseline | from baseline up to 12 weeks |
|
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| Secondary | 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 | Posted | Geometric Mean | Full Range | percent of baseline | baseline at week 0 and pre-dose at weeks 4, 8 and 12 |
|
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| Secondary | 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 | Posted | Geometric Mean | Full Range | percent of baseline | baseline at week 0 and pre-dose at weeks 4, 8 and 12 |
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| Secondary | 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 | Posted | Geometric Mean | Full Range | percent of baseline | baseline and 5 minutes anter first dose |
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| Secondary | 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 | Posted | Geometric Mean | Full Range | percent of baseline | baseline and 5 minutes anter first dose |
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| Secondary | 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 | Posted | Mean | Standard Deviation | L/min | run-in period and 12 week |
|
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| Secondary | 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 | Posted | Mean | Standard Deviation | L/min | run-in period and 12 week |
|
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| Secondary | 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 | Posted | Mean | Standard Deviation | scores on a scale per day | run-in period up to 12 weeks |
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| Secondary | 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 | Posted | Mean | Standard Deviation | scores on a scale per day | run-in period up to 12 weeks |
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| Secondary | 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 | Posted | Mean | Standard Deviation | scores on a scale per day | run-in period up to 12 weeks |
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| Secondary | 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 | Posted | Mean | Standard Deviation | medication doses per day | 12 weeks (end of run-in to last visit) |
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| Secondary | 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. | Posted | Mean | Standard Deviation | Scores on a scale | 12 weeks (end of run-in to last visit) |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Formoterol 4.5 Bid | Formoterol 4.5 ug bid | 6 | 206 | 33 | 206 | ||
| EG001 | Formoterol 9.0 Bid | Formoterol 9.0 ug bid | 7 | 199 | 31 | 199 | ||
| EG002 | Placebo | Placebo | 4 | 208 | 31 | 208 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Lobar Pneumonia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Bladder Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
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| Gastric Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
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| Prostate Caner | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
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| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
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| Hypoglycaemic Unconsciousness | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
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| Angina Pectoris | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Cardiopulmonary Failure | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | aztrial_results_posting@astrazeneca.com |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000068759 | Formoterol Fumarate |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
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| Male |
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