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The primary objective of this study is to compare the efficacy of Symbicort SMART (Symbicort Turbuhaler 160/4.5μg, one inhalation twice daily plus as needed) with Symbicort Turbuhaler 160/4.5μg, one inhalation twice daily plus terbutaline Turbuhaler 0.4 mg as needed, as asthma therapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Symbicort Turbuhaler 160/4.5 µg one inhalation bid (twice daily) + Symbicort Turbuhaler 160/4.5 µg as needed |
|
| 2 | Active Comparator | Symbicort Turbuhaler 160/4.5 µg one inhalation bid (twice daily) + terbutaline Turbuhaler 0.4 mg as needed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Symbicort Turbuhaler | Drug | 160/4.5 µg |
| |
| Terbutaline Turbuhaler |
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Participants Who Had Experienced Asthma Exacerbation(s) at the End of the Study | Asthma exacerbation was defined as deterioration in asthma leading to oral glucocorticosteroid [GCS] treatment, hospitalization, or emergency room [ER] treatment. | week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Asthma Exacerbations | Asthma exacerbation was defined as deterioration in asthma leading to oral GCS treatment, hospitalization, or ER treatment. Number of asthma exacerbations during 52 weeks treatment was presented here. | up to 52 weeks |
| Morning Peak Expiratory Flow (PEF) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tomas Andersson, MD | AstraZeneca R&D Lund | Study Director |
| Tito Atienza, M.D. | Mary Mediatrix Medical Center, Lipa City, Philippines | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Buenos Aires | Argentina | Argentina | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32718193 | Derived | Zhang O, Minku LL, Gonem S. Detecting asthma exacerbations using daily home monitoring and machine learning. J Asthma. 2021 Nov;58(11):1518-1527. doi: 10.1080/02770903.2020.1802746. Epub 2020 Aug 14. |
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The study started with an enrolment visit, Visit 1, 1-7 days prior to Visit 2 (run-in). At Visit 2 patients had to have a reversibility of ≥12% relative to baseline and their pre-bronchodilatory Forced expiratory volume in one second (FEV1) had to be ≥50% of the predicted normal value.
The first participant entered the study on 16 February 2009, and the last participant completed the study on 23 February 2011. A total of 3209 participants were enrolled at 148 centres in 13 countries in Asia, America and Europe, and 2091 participants who fulfilled the randomisation criteria were randomised.
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| ID | Title | Description |
|---|---|---|
| FG000 | Symbicort SMART | Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed |
| FG001 | Symbicort+Terbutaline As Needed |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
0.4 mg |
|
The mean value from a 52-week treatment period. |
| 52-week treatment period |
| Evening PEF | The mean value from a 52-week treatment period. | 2-week run-in period (14 - 18 days before randomization - week 0) and a 52-week treatment period |
| Forced Expiratory Volume in One Second (FEV1) | The mean value for Weeks 4, 12, 24, 36 and 52 was analysed. | 4, 12, 24, 36 and 52 weeks after randomization |
| Use of As-needed Medication | The mean value of total daily number of inhalations from the treatment period for use of as-needed medication (daytime, night-time). | 52-week treatment period |
| Asthma Symptom Score | The mean value from the treatment period for Total Asthma Symptom Score (total score: 0 is best - no asthma symptoms; 6 is worst). | 52-week treatment period |
| Nights With Awakening(s) Due to Asthma Symptoms | The mean value from the treatment period was presented here. | 52-week treatment period |
| The Percentage of Participants Who Had Experienced First Mild Asthma Exacerbations | Mild asthma exacerbation was defined as morning PEF ≥20% below baseline, daily as-needed medication use ≥2 inhalations above baseline, or a night with awakening due to asthma symptoms. The percentage of participants who had experienced mild asthma exacerbation(s) at the end of the study was presented here. | up to 52 weeks |
| Symptom-free Days (no Symptoms and no Awakenings) | A symptom-free day was defined as a day without daytime or night-time symptoms and without night-time awakenings due to asthma symptoms. The mean value was presented here. | 52-week treatment period |
| Percentage of As-needed-free Days | An as-needed-free day is defined as a night and day with no use of as-needed medication. The mean value from the treatment period was presented here. | 52-week treatment period |
| Percentage of Asthma-control Days (no Asthma Symptoms, no Awakenings, and no As-needed Use) | An asthma-control day was defined as a a night and day with no asthma symptoms, no awakenings due to asthma symptoms, and no as-needed medication use. The mean value from the treatment period was presented here. | 52-week treatment period |
| Asthma Control Questionnaire (ACQ) | The ACQ developed by Juniper and colleagues (Juniper et al 1999) was used without the FEV1 and Beta 2-agonist questions. The Asthma Control Questionnaire has 5 questions that are assessed on a 7-point scale from 0 to 6 where 0 represents good control and 6 represents poor control. The overall score is the mean of the five responses. At least 4 out of the 5 questions must have been answered to provide a value. The mean of the overall score for Weeks 4 to 52 was presented here. | 4, 12, 24, 36 and 52 weeks after randomization |
| Capital Federal |
| Buenos Aires |
| Argentina |
| Research Site | Mar del Plata | Buenos Aires | Argentina |
| Research Site | Monte Grande | Buenos Aires | Argentina |
| Research Site | Quilmes | Buenos Aires | Argentina |
| Research Site | Rosario | Santa Fe Province | Argentina |
| Research Site | Santa Fe | Santa Fe Province | Argentina |
| Research Site | San Miguel de Tucumán | Tucumán Province | Argentina |
| Research Site | Ciudad de Buenos Aires | Argentina |
| Research Site | Porto Alegre | Brasil | Brazil |
| Research Site | Belo Horizonte | Minas Gerais | Brazil |
| Research Site | Juiz de Fora | Minas Gerais | Brazil |
| Research Site | Rio de Janeiro | Rio de Janeiro | Brazil |
| Research Site | Porto Alegre | Rio Grande do Sul | Brazil |
| Research Site | Florianópolis | Santa Catarina | Brazil |
| Research Site | Santo André | São Paulo | Brazil |
| Research Site | Shenyang | Liaoning | China |
| Research Site | Hangzhou | Zhejiang | China |
| Research Site | Chongqing | China |
| Research Site | Guangzhou | China |
| Research Site | Nanjing | China |
| Research Site | Qingdao | China |
| Research Site | Shanghai | China |
| Research Site | Xi'an | China |
| Research Site | Tres Ríos | Cartago Province | Costa Rica |
| Research Site | Barrio San Bosco | Provincia de San José | Costa Rica |
| Research Site | Budapest | Hungary |
| Research Site | Cegléd | Hungary |
| Research Site | Debrecen | Hungary |
| Research Site | Deszk | Hungary |
| Research Site | Gyula | Hungary |
| Research Site | Nyíregyháza | Hungary |
| Research Site | Százhalombatta | Hungary |
| Research Site | Bangalore | Karnataka | India |
| Research Site | Mangalore | Karnataka | India |
| Research Site | Mysore | Karnataka | India |
| Research Site | Trivandrum | Kerala | India |
| Research Site | Mumbai | Maharashtra | India |
| Research Site | Nagpur | Maharashtra | India |
| Research Site | Pune | Maharashtra | India |
| Research Site | Jaipur | Rajasthan | India |
| Research Site | Coimabatore | Tamil Nadu | India |
| Research Site | Noida | India |
| Research Site | Komaki | Aichi-ken | Japan |
| Research Site | Seto | Aichi-ken | Japan |
| Research Site | Asahi | Chiba | Japan |
| Research Site | Matsuyama | Ehime | Japan |
| Research Site | Fukuoka | Fukuoka | Japan |
| Research Site | Kitakyushu | Fukuoka | Japan |
| Research Site | Yanagawa | Fukuoka | Japan |
| Research Site | Isesaki | Gunma | Japan |
| Research Site | Ōwa | Gunma | Japan |
| Research Site | Fukuyama | Hiroshima | Japan |
| Research Site | Hiroshima | Hiroshima | Japan |
| Research Site | Asahikawa | Hokkaido | Japan |
| Research Site | Chitose | Hokkaido | Japan |
| Research Site | Sapporo | Hokkaido | Japan |
| Research Site | Tomakomai | Hokkaido | Japan |
| Research Site | Ako | Hyōgo | Japan |
| Research Site | Himeji | Hyōgo | Japan |
| Research Site | Kobe | Hyōgo | Japan |
| Research Site | Hitachi | Ibaraki | Japan |
| Research Site | Naka-gun | Ibaraki | Japan |
| Research Site | Morioka | Iwate | Japan |
| Research Site | Sakaidechō | Kagawa-ken | Japan |
| Research Site | Kagoshima | Kagoshima-ken | Japan |
| Research Site | Kawasaki | Kanagawa | Japan |
| Research Site | Kawasaki-shi | Kanagawa | Japan |
| Research Site | Yokohama | Kanagawa | Japan |
| Research Site | Kochi | Kochi | Japan |
| Research Site | Kyoto | Kyoto | Japan |
| Research Site | Sendai | Miyagi | Japan |
| Research Site | Nagaoka | Niigata | Japan |
| Research Site | Niigata | Niigata | Japan |
| Research Site | Beppu | Oita Prefecture | Japan |
| Research Site | Ōita | Oita Prefecture | Japan |
| Research Site | Kurashiki | Okayama-ken | Japan |
| Research Site | Okayama | Okayama-ken | Japan |
| Research Site | Sakai | Osaka | Japan |
| Research Site | Matsue | Shimane | Japan |
| Research Site | Utsunomiya | Tochigi | Japan |
| Research Site | Chūō | Tokyo | Japan |
| Research Site | Kodaira | Tokyo | Japan |
| Research Site | Kokubunji | Tokyo | Japan |
| Research Site | Machida | Tokyo | Japan |
| Research Site | Nakano-ku | Tokyo | Japan |
| Research Site | tabashi City | Tokyo | Japan |
| Research Site | Toshima-ku | Tokyo | Japan |
| Research Site | Kubang Kerian | Kelantan | Malaysia |
| Research Site | Kuantan | Pahang | Malaysia |
| Research Site | Batu Caves | Selangor | Malaysia |
| Research Site | George Town | Malaysia |
| Research Site | Kuala Lumpur | Malaysia |
| Research Site | Lima | Lima Province | Peru |
| Research Site | Surco | Lima region | Peru |
| Research Site | Lipa City | Batangas | Philippines |
| Research Site | Davao City | Philippines | Philippines |
| Research Site | Iloilo City | Philippines |
| Research Site | Manila | Philippines |
| Research Site | Quezon City | Philippines |
| Research Site | Bucheon-si | South Korea |
| Research Site | Cheongju-si | South Korea |
| Research Site | Seoul | South Korea |
| Research Site | Suwon | South Korea |
| Research Site | Bangkoknoi | Bangkok | Thailand |
| Research Site | Hat Yai | Changwat Songkhla | Thailand |
| Research Site | Naimuang | Nakhonratchasima | Thailand |
| Research Site | Bangkok | Thailand | Thailand |
| Research Site | Khon Kaen | Thailand |
Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Symbicort SMART | Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed |
| BG001 | Symbicort+Terbutaline As Needed | Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed |
| 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 | The Percentage of Participants Who Had Experienced Asthma Exacerbation(s) at the End of the Study | Asthma exacerbation was defined as deterioration in asthma leading to oral glucocorticosteroid [GCS] treatment, hospitalization, or emergency room [ER] treatment. | The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline. | Posted | Number | percentage of participants | week 52 |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Asthma Exacerbations | Asthma exacerbation was defined as deterioration in asthma leading to oral GCS treatment, hospitalization, or ER treatment. Number of asthma exacerbations during 52 weeks treatment was presented here. | The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline. | Posted | Number | Asthma exacerbations | up to 52 weeks |
|
| ||||||||||||||||||||||||||||||
| Secondary | Morning Peak Expiratory Flow (PEF) | The mean value from a 52-week treatment period. | The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline. | Posted | Mean | Standard Deviation | Liter/minute (L/min) | 52-week treatment period |
|
| |||||||||||||||||||||||||||||
| Secondary | Evening PEF | The mean value from a 52-week treatment period. | The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline. | Posted | Mean | Standard Deviation | L/min | 2-week run-in period (14 - 18 days before randomization - week 0) and a 52-week treatment period |
|
| |||||||||||||||||||||||||||||
| Secondary | Forced Expiratory Volume in One Second (FEV1) | The mean value for Weeks 4, 12, 24, 36 and 52 was analysed. | The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline. | Posted | Geometric Mean | Standard Deviation | Liter (L) | 4, 12, 24, 36 and 52 weeks after randomization |
|
| |||||||||||||||||||||||||||||
| Secondary | Use of As-needed Medication | The mean value of total daily number of inhalations from the treatment period for use of as-needed medication (daytime, night-time). | The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline. | Posted | Mean | Standard Deviation | inhalations/day | 52-week treatment period |
|
| |||||||||||||||||||||||||||||
| Secondary | Asthma Symptom Score | The mean value from the treatment period for Total Asthma Symptom Score (total score: 0 is best - no asthma symptoms; 6 is worst). | The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline. | Posted | Mean | Standard Deviation | units on a scale | 52-week treatment period |
|
| |||||||||||||||||||||||||||||
| Secondary | Nights With Awakening(s) Due to Asthma Symptoms | The mean value from the treatment period was presented here. | The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline. | Posted | Mean | Standard Deviation | Nights With Awakening(s) | 52-week treatment period |
|
| |||||||||||||||||||||||||||||
| Secondary | The Percentage of Participants Who Had Experienced First Mild Asthma Exacerbations | Mild asthma exacerbation was defined as morning PEF ≥20% below baseline, daily as-needed medication use ≥2 inhalations above baseline, or a night with awakening due to asthma symptoms. The percentage of participants who had experienced mild asthma exacerbation(s) at the end of the study was presented here. | The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline. | Posted | Number | percentage of participants | up to 52 weeks |
|
| ||||||||||||||||||||||||||||||
| Secondary | Symptom-free Days (no Symptoms and no Awakenings) | A symptom-free day was defined as a day without daytime or night-time symptoms and without night-time awakenings due to asthma symptoms. The mean value was presented here. | The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline. | Posted | Mean | Standard Deviation | symptom-free days | 52-week treatment period |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of As-needed-free Days | An as-needed-free day is defined as a night and day with no use of as-needed medication. The mean value from the treatment period was presented here. | The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline. | Posted | Mean | Standard Deviation | percentage of as-needed-free days | 52-week treatment period |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Asthma-control Days (no Asthma Symptoms, no Awakenings, and no As-needed Use) | An asthma-control day was defined as a a night and day with no asthma symptoms, no awakenings due to asthma symptoms, and no as-needed medication use. The mean value from the treatment period was presented here. | The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline. | Posted | Mean | Standard Deviation | percentage of asthma-control days | 52-week treatment period |
|
| |||||||||||||||||||||||||||||
| Secondary | Asthma Control Questionnaire (ACQ) | The ACQ developed by Juniper and colleagues (Juniper et al 1999) was used without the FEV1 and Beta 2-agonist questions. The Asthma Control Questionnaire has 5 questions that are assessed on a 7-point scale from 0 to 6 where 0 represents good control and 6 represents poor control. The overall score is the mean of the five responses. At least 4 out of the 5 questions must have been answered to provide a value. The mean of the overall score for Weeks 4 to 52 was presented here. | The analysis set for efficacy was based on the full analysis set (FAS) in line with the ICH E9 guideline. | Posted | Mean | Standard Deviation | units on a scale | 4, 12, 24, 36 and 52 weeks after randomization |
|
|
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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 SMART | Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed | 41 | 1,049 | 279 | 1,049 | ||
| EG001 | Symbicort+Terbutaline As Needed | Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed | 74 | 1,042 | 293 | 1,042 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Myocardial Infarction | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Angina Pectoris | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Angina Unstable | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Coronary Artery Disease | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cleft Lip | Congenital, familial and genetic disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Meniere's Disease | Ear and labyrinth disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Basedow's Disease | Endocrine disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Retinal Detachment | Eye disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Abdominal Hernia | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Acute Abdomen | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Anal Fissure | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Colonic Polyp | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Gastric Polyps | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hernia Obstructive | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hepatotoxicity | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Drug Hypersensitivity | Immune system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Tracheobronchitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection Bacterial | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Acute Sinusitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Breast Abscess | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| H1n1 Influenza | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Lower Respiratory Tract Infection Bacterial | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Otitis Media Chronic | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Pneumonia Bacterial | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Tooth Abscess | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Varicella | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Viral Infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Traumatic Brain Injury | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Foot Fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Joint Injury | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Lower Limb Fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Muscle Strain | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Patella Fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Sternal Fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| Type 2 Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Rheumatoid Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Uterine Leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Breast Cancer In Situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Intestinal Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Metastatic Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Rectal Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Abortion Spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 13.1 | Systematic Assessment |
| |
| Abortion Threatened | Pregnancy, puerperium and perinatal conditions | MedDRA 13.1 | Systematic Assessment |
| |
| Premature Baby | Pregnancy, puerperium and perinatal conditions | MedDRA 13.1 | Systematic Assessment |
| |
| Major Depression | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Breast Calcifications | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dysfunctional Uterine Bleeding | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Endometriosis | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Infertility Male | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Nasal Septum Deviation | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Viral Upper Respiratory Tract Infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | aztrial_results_posting@astrazeneca.com |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069502 | Budesonide, Formoterol Fumarate Drug Combination |
| ID | Term |
|---|---|
| D000068759 | Formoterol Fumarate |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D019819 | Budesonide |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
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