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The primary purpose of the study is to investigate if Symbicort is more effective than Oxis in increasing forced expiratory volume in one second (FEV1), measured at the clinics, in patients with COPD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Symbicort Turbuhaler 160/4.5 microgram, 2 inhalations twice daily |
|
| 2 | Active Comparator | Oxis Turbuhaler 4.5 microgram, 2 inhalations twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Budesonide/formoterol (Symbicort Turbuhaler) | Drug | 2x160/4.5 microgram, inhalation, twice daily, 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pre-dose Forced Expiratory Volume in One Second (FEV1) | The ratio, expressed as percentage, of the geometric mean of available data for Weeks 0, 4, 8 and 12 to the baseline for each treatment group | Before randomization, 0, 4, 8 and 12 weeks after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 1 Hour Post Dose Forced Expiratory Volume in One Second (FEV1) | The ratio, expressed as percentage, of the geometric mean of available data for Weeks 0, 4, 8 and 12 to the baseline for each treatment group | Before randomization, 0, 4, 8 and 12 weeks after randomization |
| Pre-dose Forced Vital Capacity (FVC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lars-Göran Carlsson, MD | AstraZeneca R&D, Lund, Sweden | Study Chair |
| Yoshinosuke Fukuchi, M.D., PhD | Department of Respiratory medicine, Juntendo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Bangalore | Karnataka | India | |||
| Research Site |
The study started with an enrolment visit, Visit 1, 0 to 4 weeks prior to Visit 2, and 1-2 week run-in period before randomization. At Visit 2 participants had to have pre-bronchodilatory forced expiratory volume in one second (FEV1) less than or equal to 50 percent of the predicted normal value.
The first participant entered the study on 28 January 2010, and the last participant completed the study on 30 March 2011. A total of 1,710 participants were enrolled at 163 centres in 9 countries in Asia and Europe, and 1,293 participants who fulfilled the randomisation criteria were randomised.
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| ID | Title | Description |
|---|---|---|
| FG000 | Symbicort Turbuhaler (Experimental) | Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid) |
| FG001 | Oxis Turbuhaler (Active Comparator) | Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Formoterol (Oxis Turbuhaler) | Drug | 2 X 4.5 microgram, inhalation, twice daily, 12 weeks |
|
|
The ratio, expressed as percentage, of the geometric mean of available data for Weeks 0, 4, 8 and 12 to the baseline for each treatment group |
| Before randomization, 0, 4, 8 and 12 weeks after randomization |
| 1 Hour Post-dose Forced Vital Capacity (FVC) | The ratio, expressed as percentage, of the geometric mean of available data for Weeks 0, 4, 8 and 12 to the baseline for each treatment group | Before randomization, 0, 4, 8 and 12 weeks after randomization |
| Percentage of Participants With Exacerbations | 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. The percentage of participants who had experienced COPD exacerbation at the end of the study for each treatment group. | Daily during 12-week randomization treatment |
| Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation | 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 12-week randomization treatment | Daily during 12-week randomization treatment |
| Morning Peak Expiratory Flow(PEF) | The change from Run-in period average to Treatment period average for each treatment group | Daily during run-in period and daily during 12-week randomization treatment |
| Evening Peak Expiratory Flow (PEF) | The change from Run-in period average to Treatment period average for each treatment group | Daily during run-in period and daily during 12-week randomization treatment |
| Total Number of Day With Exacerbation | Total number of days with COPD exacerbation for each treatment group | Daily during 12-week randomization treatment |
| Morning Forced Expiratory Volume in One Second (FEV1) | The change from Run-in period average to Treatment period average for each treatment group | Daily during run-in period and daily during 12-week randomization treatment |
| Evening Forced Expiratory Volume in One Second (FEV1) | The change from Run-in period average to Treatment period average for each treatment group | Daily during run-in period and daily during 12-week randomization treatment |
| Night-time Awakening Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms | Scored 0 to 1 (0 = no awakening and 1 = awakening). The change from Run-in period average to Treatment period average for each treatment group | Daily during run-in period and daily during 12-week randomization treatment |
| Breathlessness Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms | 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 | Daily during run-in period and daily during 12-week randomization treatment |
| Cough Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms | 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 | Daily during run-in period and daily during 12-week randomization treatment |
| Total Chronic Obstructive Pulmonary Disease (COPD) Symptom Score | 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. | Daily during run-in period and daily during 12-week randomization treatment |
| Use of Rescue Medication | The change from Run-in period average to Treatment period average for each treatment group. | Daily during run-in period and daily during 12-week randomization treatment |
| St George's Respiratory Questionnaire (SGRQ) Total Score | The change from Run-in period average to Treatment period average for each treatment group. The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life). | Daily during run-in period and daily during 12-week randomization treatment |
| Mysore |
| Karnataka |
| India |
| Research Site | Trivandrum | Kerala | India |
| Research Site | Indore | Madhya Pradesh | India |
| Research Site | Nagpur | Maharashtra | India |
| Research Site | New Delhi | National Capital Territory of Delhi | India |
| Research Site | Coimbatore | Tamil Nadu | India |
| Research Site | Nagoya | Aichi-ken | Japan |
| Research Site | Okazaki | Aichi-ken | Japan |
| Research Site | Seto | Aichi-ken | Japan |
| Research Site | Toyota | Aichi-ken | Japan |
| Research Site | Toyota-shi | Aichi-ken | Japan |
| Research Site | Akita | Akita | Japan |
| Research Site | Fukuoka | Fukuoka | Japan |
| Research Site | Yanagawa | Fukuoka | Japan |
| Research Site | Gifu | Gifu | Japan |
| Research Site | Takayama-shi | Gifu | Japan |
| Research Site | Maebashi | Gunma | Japan |
| Research Site | Ōta | Gunma | Japan |
| Research Site | Hiroshima | Hiroshima | Japan |
| Research Site | Asahikawa | Hokkaido | Japan |
| Research Site | Obihiro | Hokkaido | Japan |
| Research Site | Sapporo | Hokkaido | Japan |
| Research Site | Tomakomai | Hokkaido | Japan |
| Research Site | Himeji | Hyōgo | Japan |
| Research Site | Itami | Hyōgo | Japan |
| Research Site | Kobe | Hyōgo | Japan |
| Research Site | Naka-gun | Ibaragi | Japan |
| Research Site | Hitachi | Ibaraki | Japan |
| Research Site | Tsukuba | Ibaraki | Japan |
| Research Site | Kanazawa | Ishikawa-ken | Japan |
| Research Site | Sakaidechō | Kagawa-ken | Japan |
| Research Site | Kagoshima | Kagoshima-ken | Japan |
| Research Site | Fujisawa | Kanagawa | Japan |
| Research Site | Kawasaki-shi | Kanagawa | Japan |
| Research Site | Yokohama | Kanagawa | Japan |
| Research Site | Zama-shi | Kanagawa | Japan |
| Research Site | Kochi | Kochi | Japan |
| Research Site | Kyoto | Kyoto | Japan |
| Research Site | Matsusaka-shi | Mie-ken | Japan |
| Research Site | Murata | Miyagi | Japan |
| Research Site | Sendai | Miyagi | Japan |
| Research Site | Chino-shi | Nagano | Japan |
| Research Site | Matsumoto | Nagano | Japan |
| Research Site | Isahaya-shi | Nagasaki | Japan |
| Research Site | Nagaoka | Niigata | Japan |
| Research Site | Saiki-shi | Oita Prefecture | Japan |
| Research Site | Yufu-shi | Oita Prefecture | Japan |
| Research Site | Kurashiki-shi | Okayama-ken | Japan |
| Research Site | Okayama | Okayama-ken | Japan |
| Research Site | Urasoe-shi | Okinawa | Japan |
| Research Site | Izumi-shi | Osaka | Japan |
| Research Site | Kishiwada | Osaka | Japan |
| Research Site | Moriguchi | Osaka | Japan |
| Research Site | Osaka | Osaka | Japan |
| Researche Site | Sakai-shi | Osaka | Japan |
| Research Site | Saga | Saga-ken | Japan |
| Research Site | Kitakatsushika-gun | Saitama | Japan |
| Research Site | Koshigaya-shi | Saitama | Japan |
| Research Site | Matsue | Shimane | Japan |
| Research Site | Chūō | Tokyo | Japan |
| Research Site | Itabashi-ku | Tokyo | Japan |
| Research Site | Meguro City | Tokyo | Japan |
| Research Site | Minato-ku | Tokyo | Japan |
| Research Site | Setagaya City | Tokyo | Japan |
| Research Site | Shinagawa-ku | Tokyo | Japan |
| Research Site | Suginami-ku | Tokyo | Japan |
| Research Site | Sumida-ku | Tokyo | Japan |
| Research Site | Wakayama | Wakayama | Japan |
| Researche Site | San Fernando City | Pampanga | Philippines |
| Research Site | Davao City | Philippines | Philippines |
| Research Site | Iloilo City | Philippines |
| Research Site | Lipa City, Batangas | Philippines |
| Research Site | Olongapo City | Philippines |
| Research Site | Quezon City | Philippines |
| Research Site | Bialystok | Poland |
| Research Site | Bydgoszcz | Poland |
| Research Site | Chodzież | Poland |
| Research Site | Jarosław | Poland |
| Research Site | Karpacz | Poland |
| Research Site | Krakow | Poland |
| Research Site | Lodz | Poland |
| Research Site | Loma | Poland |
| Research Site | Lublin | Poland |
| Research Site | Ostrów Wielkopolski | Poland |
| Research Site | Piła | Poland |
| Research Site | Poznan | Poland |
| Research Site | Ruda Śląska | Poland |
| Research Site | Słupca | Poland |
| Research Site | Tczew | Poland |
| Research Site | Torun | Poland |
| Research Site | Turek | Poland |
| Research Site | Włoszczowa | Poland |
| Research Site | Zabrze | Poland |
| Research Site | Zawadzkie | Poland |
| Research Site | Żnin | Poland |
| Research Site | Barnaul | Russia | Russia |
| Research Site | Kazan' | Russia | Russia |
| Research Site | Moscow | Russia | Russia |
| Research Site | Saint Petersburg | Russia | Russia |
| Research Site | Yekaterinburg | Russia | Russia |
| Research Site | Novosibirsk | Russia |
| Research Site | Vladikavkaz | Russia |
| Research Site | Ansan | South Korea |
| Research Site | Incheon | South Korea |
| Research Site | Seoul | South Korea |
| Research Site | Chiayi City | Taiwan |
| Research Site | Kaohsiung City | Taiwan |
| Research Site | Keelung | Taiwan |
| Research Site | Taipei | Taiwan |
| Research Site | Dnipropetrovsk | Ukraine |
| Research Site | Donetsk | Ukraine |
| Research Site | Kyiv | Ukraine |
| Research Site | Poltava | Ukraine |
| Research Site | Uzhhorod | Ukraine |
| Research Site | Vinytsa | Ukraine |
| Research Site | Zaporozye | Ukraine |
| Research Site | Ho Chi Minh City | Vietnam | Vietnam |
| Research Site | Hanoi | Vietnam |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Symbicort Turbuhaler (Experimental) | Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid) |
| BG001 | Oxis Turbuhaler (Active Comparator) | Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Full Range | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Pre-dose Forced Expiratory Volume in One Second (FEV1) | The ratio, expressed as percentage, of the geometric mean of available data for Weeks 0, 4, 8 and 12 to the baseline for each treatment group | The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis. | Posted | Geometric Mean | Full Range | percentage of Baseline | Before randomization, 0, 4, 8 and 12 weeks after randomization |
|
|
| ||||||||||||||||||||||||||||
| Secondary | 1 Hour Post Dose Forced Expiratory Volume in One Second (FEV1) | The ratio, expressed as percentage, of the geometric mean of available data for Weeks 0, 4, 8 and 12 to the baseline for each treatment group | The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis. | Posted | Geometric Mean | Full Range | percentage of Baseline | Before randomization, 0, 4, 8 and 12 weeks after randomization |
|
| |||||||||||||||||||||||||||||
| Secondary | Pre-dose Forced Vital Capacity (FVC) | The ratio, expressed as percentage, of the geometric mean of available data for Weeks 0, 4, 8 and 12 to the baseline for each treatment group | The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis. | Posted | Geometric Mean | Full Range | percentage of Baseline | Before randomization, 0, 4, 8 and 12 weeks after randomization |
|
| |||||||||||||||||||||||||||||
| Secondary | 1 Hour Post-dose Forced Vital Capacity (FVC) | The ratio, expressed as percentage, of the geometric mean of available data for Weeks 0, 4, 8 and 12 to the baseline for each treatment group | The analysis set for efficacy was based on the Full Analysis Set (FAS. Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis. | Posted | Geometric Mean | Full Range | percentage of Baseline | Before randomization, 0, 4, 8 and 12 weeks after randomization |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Exacerbations | 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. The percentage of participants who had experienced COPD exacerbation at the end of the study for each treatment group. | The analysis set for efficacy was based on the Full Analysis Set (FAS).Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis. | Posted | Number | percentage of participants | Daily during 12-week randomization treatment |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation | 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 12-week randomization treatment | The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis. | Posted | Number | event | Daily during 12-week randomization treatment |
|
| ||||||||||||||||||||||||||||||
| Secondary | Morning Peak Expiratory Flow(PEF) | The change from Run-in period average to Treatment period average for each treatment group | The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis. | Posted | Mean | Standard Deviation | Liter/minute (L/min) | Daily during run-in period and daily during 12-week randomization treatment |
|
| |||||||||||||||||||||||||||||
| Secondary | Evening Peak Expiratory Flow (PEF) | The change from Run-in period average to Treatment period average for each treatment group | The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis. | Posted | Mean | Standard Deviation | Liter/minute (L/min) | Daily during run-in period and daily during 12-week randomization treatment |
|
| |||||||||||||||||||||||||||||
| Secondary | Total Number of Day With Exacerbation | Total number of days with COPD exacerbation for each treatment group | The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis. | Posted | Number | days | Daily during 12-week randomization treatment |
|
| ||||||||||||||||||||||||||||||
| Secondary | Morning Forced Expiratory Volume in One Second (FEV1) | The change from Run-in period average to Treatment period average for each treatment group | The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis. | Posted | Mean | Standard Deviation | Liter (L) | Daily during run-in period and daily during 12-week randomization treatment |
|
| |||||||||||||||||||||||||||||
| Secondary | Evening Forced Expiratory Volume in One Second (FEV1) | The change from Run-in period average to Treatment period average for each treatment group | The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis. | Posted | Mean | Standard Deviation | Liter (L) | Daily during run-in period and daily during 12-week randomization treatment |
|
| |||||||||||||||||||||||||||||
| Secondary | Night-time Awakening Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms | Scored 0 to 1 (0 = no awakening and 1 = awakening). The change from Run-in period average to Treatment period average for each treatment group | The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis. | Posted | Mean | Standard Deviation | Nights with symptoms | Daily during run-in period and daily during 12-week randomization treatment |
|
| |||||||||||||||||||||||||||||
| Secondary | Breathlessness Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms | 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 | The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | Daily during run-in period and daily during 12-week randomization treatment |
|
| |||||||||||||||||||||||||||||
| Secondary | Cough Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms | 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 | The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | Daily during run-in period and daily during 12-week randomization treatment |
|
| |||||||||||||||||||||||||||||
| Secondary | Total Chronic Obstructive Pulmonary Disease (COPD) Symptom Score | 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. | The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | Daily during run-in period and daily during 12-week randomization treatment |
|
| |||||||||||||||||||||||||||||
| Secondary | Use of Rescue Medication | The change from Run-in period average to Treatment period average for each treatment group. | The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis. | Posted | Mean | Standard Deviation | inhalations/day | Daily during run-in period and daily during 12-week randomization treatment |
|
| |||||||||||||||||||||||||||||
| Secondary | St George's Respiratory Questionnaire (SGRQ) Total Score | The change from Run-in period average to Treatment period average for each treatment group. The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life). | The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | Daily during run-in period and daily during 12-week randomization treatment |
|
|
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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 | Symbicort Turbuhaler (Experimental) | Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid) | 43 | 636 | 61 | 636 | ||
| EG001 | Oxis Turbuhaler (Active Comparator) | Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid) | 45 | 657 | 66 | 657 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| PNEUMOTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| ACUTE RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| HAEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| PNEUMONIA | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| APPENDICITIS | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| PNEUMONIA BACTERIAL | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| BRONCHOPNEUMONIA | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| POSTOPERATIVE ABSCESS | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| COLITIS ISCHAEMIC | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| DIVERTICULUM INTESTINAL HAEMORRHAGIC | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| ILEUS | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| PANCREATIC MASS | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| PERITONITIS | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| COLON CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| |
| GASTRIC CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| |
| HEPATIC NEOPLASM MALIGNANT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| |
| LUNG NEOPLASM MALIGNANT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| |
| METASTASES TO LUNG | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| |
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| ANGINA PECTORIS | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| ANGINA UNSTABLE | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| CARDIAC FAILURE | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| CARDIAC FAILURE CHRONIC | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| CARDIOVASCULAR INSUFFICIENCY | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| CORONARY ARTERY INSUFFICIENCY | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| MYOCARDIAL ISCHAEMIA | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| BRAIN STEM STROKE | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| HYPOXIC-ISCHAEMIC ENCEPHALOPATHY | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| ISCHAEMIC STROKE | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| AMAUROSIS FUGAX | Eye disorders | MedDRA 14.0 | Systematic Assessment |
| |
| CATARACT | Eye disorders | MedDRA 14.0 | Systematic Assessment |
| |
| HYPOGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| CHOLECYSTITIS ACUTE | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| DEATH | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| AORTIC ANEURYSM RUPTURE | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
| |
| COMPUTERISED TOMOGRAM THORAX ABNORMAL | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
Not provided
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D019819 | Budesonide |
| D000068759 | Formoterol Fumarate |
| D000069502 | Budesonide, Formoterol Fumarate Drug Combination |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
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