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This study will last up to 3 years. You will visit the clinic up to 14 times. Certain visits will include lung function tests and scans of your bones. The purpose of this study is to determine the effect of the steroid component of an inhaled product on bone mineral density in patients with Chronic Obstructive Pulmonary Disease (COPD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Salmeterol 50 mcg BID | Experimental | Participants randomized to this arm received salmeterol 50 microgram (mcg), formulated with lactose via the DISKUS™ inhaler one inhalation twice daily (BID) one inhalation in the morning and one inhalation in the evening for 156 Weeks. Each DISKUS contained 60 doses of study medication. Participant were provided with albuterol/salbutamol as relief medication. DISCUS is registered trademark product of GlaxoSmithKline. |
|
| Fluticasone Propionate/Salmeterol 250/50 mcg BID | Experimental | Participants randomized to this arm received Fluticasone propionate/salmeterol combination product 250/50 mcg, formulated with lactose via the DISKUS inhaler one inhalation BID, one inhalation in the morning and one inhalation in the evening for 156 Weeks. Each DISKUS contained 60 doses of study medication. Participant were provided with albuterol/salbutamol as relief medication. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Salmeterol 50 mcg BID | Drug | Salmeterol xinafoate 50 mcg strength DISKUS inhaler (formulated with lactose), BID in the morning and evening. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine L1-L4 | BMD, a measure of bone density, reflecting the strength of bones as represented by calcium content. The BMD test detects osteopenia (mild bone loss) and osteoporosis (more severe bone loss, which may cause symptoms). BMD at the lumber spine (L1-L4) was measured via dual energy x-ray absorptiometry (DEXA) (using DEXA equipment) scans at Baseline and every 26 weeks during the study. Acceptable DEXA measurements must be conducted prior to the first dose of randomized study medication. Baseline was defined as the collections taken on Day 1 of treatment period. Change from Baseline was calculated by subtracting the Baseline value from indicated time point value. | Baseline and Week 26, 52, 78, 104, 130, and 156 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in BMD at the Total Hip | BMD, a measure of bone density, reflecting the strength of bones as represented by calcium content. The BMD test detects osteopenia (mild bone loss) and osteoporosis (more severe bone loss, which may cause symptoms).BMD at the total hip was measured via dual energy x-ray absorptiometry (DEXA) (using DEXA equipment) scans at Baseline and every 26 weeks during the study. Acceptable DEXA measurements must be conducted prior to the first dose of randomized study medication. Baseline was defined as the collections taken on day 1 of treatment period. Change from Baseline was calculated by subtracting the Baseline value from indicated time point value. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Berkeley | California | 94705 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | This study has not been published in the scientific literature. |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| SCO40041 | Statistical Analysis Plan | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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A total of 247 participants were screened for this study, of whom 61 were screen failures and 186 participants were randomized in the study.
Total 186 participants, with chronic obstructive pulmonary disease (COPD) were randomized at 31 centers in the United States. Study duration was 14-21 day Single-Blind Run-In period, 156-week treatment period and follow-up phone contact within 2 weeks of treatment stop.
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| ID | Title | Description |
|---|---|---|
| FG000 | Salmeterol 50 mcg BID | Participants randomized to this arm received salmeterol 50 microgram (mcg), formulated with lactose via the DISKUS™ inhaler one inhalation twice daily (BID) one inhalation in the morning and one inhalation in the evening for 156 Weeks. Each DISKUS contained 60 doses of study medication. Participant were provided with albuterol/salbutamol as relief medication. DISCUS is registered trademark product of GlaxoSmithKline. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Fluticasone Propionate/Salmeterol 250/50 mcg BID | Drug | Fluticasone propionate/salmeterol xinafoate combination product 250/50mcg strength DISKUS inhaler (formulated with lactose), BID in the morning and evening. |
|
|
| DISKUS inhaler | Device | Each participant received study medication via the DISKUS, for one of two possible treatment groups. Each DISKUS contained 60 doses of study medication. Participants were instructed to administer medication BID (one inhalation in the morning and one inhalation in the evening) approximately 12 hours apart for 156-week treatment period. |
|
| Baseline and Week 26, 52, 78, 104, 130, and 156 |
| Fullerton |
| California |
| 92835 |
| United States |
| GSK Investigational Site | Rancho Mirage | California | 92270 | United States |
| GSK Investigational Site | San Diego | California | 92103 | United States |
| GSK Investigational Site | Walnut Creek | California | 94598 | United States |
| GSK Investigational Site | Fort Collins | Colorado | 80528 | United States |
| GSK Investigational Site | Wheat Ridge | Colorado | 80033 | United States |
| GSK Investigational Site | Hartford | Connecticut | 06105 | United States |
| GSK Investigational Site | Fort Lauderdale | Florida | 33316 | United States |
| GSK Investigational Site | Jacksonville | Florida | 32205 | United States |
| GSK Investigational Site | Sarasota | Florida | 34239 | United States |
| GSK Investigational Site | Tamarac | Florida | 33321 | United States |
| GSK Investigational Site | Atlanta | Georgia | 30342 | United States |
| GSK Investigational Site | Chicago | Illinois | 60612 | United States |
| GSK Investigational Site | North Chicago | Illinois | 60064 | United States |
| GSK Investigational Site | Wichita | Kansas | 67207 | United States |
| GSK Investigational Site | Boston | Massachusetts | 02135 | United States |
| GSK Investigational Site | Cadillac | Michigan | 49601 | United States |
| GSK Investigational Site | Saint Charles | Missouri | 63301 | United States |
| GSK Investigational Site | Omaha | Nebraska | 68124 | United States |
| GSK Investigational Site | Bronxville | New York | 10708 | United States |
| GSK Investigational Site | Charlotte | North Carolina | 28207 | United States |
| GSK Investigational Site | Portland | Oregon | 97213 | United States |
| GSK Investigational Site | Charleston | South Carolina | 29406-7108 | United States |
| GSK Investigational Site | Greer | South Carolina | 29651 | United States |
| GSK Investigational Site | Simpsonville | South Carolina | 29681 | United States |
| GSK Investigational Site | Spartanburg | South Carolina | 29303 | United States |
| GSK Investigational Site | Kingsport | Tennessee | 37660 | United States |
| GSK Investigational Site | Milan | Tennessee | 38372 | United States |
| GSK Investigational Site | Corsicana | Texas | 75110 | United States |
| GSK Investigational Site | San Antonio | Texas | 78205 | United States |
| GSK Investigational Site | San Antonio | Texas | 78217 | United States |
| GSK Investigational Site | Richmond | Virginia | 23225 | United States |
| GSK Investigational Site | Richmond | Virginia | 23249 | United States |
| GSK Investigational Site | Bellingham | Washington | 98226 | United States |
| GSK Investigational Site | Spokane | Washington | 99202 | United States |
| GSK Investigational Site | Spokane | Washington | 99204 | United States |
For additional information about this study please refer to the GSK Clinical Study Register |
| SCO40041 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SCO40041 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SCO40041 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SCO40041 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SCO40041 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SCO40041 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FG001 | Fluticasone Propionate/Salmeterol 250/50 mcg BID | Participants randomized to this arm received Fluticasone propionate/salmeterol combination product 250/50 mcg, formulated with lactose via the DISKUS inhaler one inhalation BID, one inhalation in the morning and one inhalation in the evening for 156 Weeks. Each DISKUS contained 60 doses of study medication. Participant were provided with albuterol/salbutamol as relief medication. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Salmeterol 50 mcg BID | Participants randomized to this arm received salmeterol 50 mcg, formulated with lactose via the DISKUS inhaler one inhalation BID one inhalation in the morning and one inhalation in the evening for 156 Weeks. Each DISKUS contained 60 doses of study medication. Participant were provided with albuterol/salbutamol as relief medication. |
| BG001 | Fluticasone Propionate/Salmeterol 250/50 mcg BID | Participants randomized to this arm received Fluticasone propionate/salmeterol combination product 250/50 mcg, formulated with lactose via the DISKUS inhaler one inhalation BID, one inhalation in the morning and one inhalation in the evening for 156 Weeks. Each DISKUS contained 60 doses of study medication. Participant were provided with albuterol/salbutamol as relief medication. |
| 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 | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | 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 | Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine L1-L4 | BMD, a measure of bone density, reflecting the strength of bones as represented by calcium content. The BMD test detects osteopenia (mild bone loss) and osteoporosis (more severe bone loss, which may cause symptoms). BMD at the lumber spine (L1-L4) was measured via dual energy x-ray absorptiometry (DEXA) (using DEXA equipment) scans at Baseline and every 26 weeks during the study. Acceptable DEXA measurements must be conducted prior to the first dose of randomized study medication. Baseline was defined as the collections taken on Day 1 of treatment period. Change from Baseline was calculated by subtracting the Baseline value from indicated time point value. | The Safety population - Safety population was defined as all randomized participants who are at least 50% compliant with taking study drug and have a post-Baseline BMD scan. Only those participants available at the specified time points were analyzed. | Posted | Mean | Standard Error | Percent Change | Baseline and Week 26, 52, 78, 104, 130, and 156 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in BMD at the Total Hip | BMD, a measure of bone density, reflecting the strength of bones as represented by calcium content. The BMD test detects osteopenia (mild bone loss) and osteoporosis (more severe bone loss, which may cause symptoms).BMD at the total hip was measured via dual energy x-ray absorptiometry (DEXA) (using DEXA equipment) scans at Baseline and every 26 weeks during the study. Acceptable DEXA measurements must be conducted prior to the first dose of randomized study medication. Baseline was defined as the collections taken on day 1 of treatment period. Change from Baseline was calculated by subtracting the Baseline value from indicated time point value. | Safety Population. Only those participants available at the specified time points were analyzed. | Posted | Mean | Standard Error | Percent Change | Baseline and Week 26, 52, 78, 104, 130, and 156 |
|
Up to 160 weeks
Intent-to-treat population was defined as all randomized participants receiving at least one dose of study drug and was analyzed according to the treatment each participant was scheduled to have received.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Salmeterol 50 mcg BID | Participants randomized to this arm received salmeterol 50 mcg, formulated with lactose via the DISKUS inhaler one inhalation BID one inhalation in the morning and one inhalation in the evening for 156 Weeks. Each DISKUS contained 60 doses of study medication. Participant were provided with albuterol/salbutamol as relief medication. | 7 | 94 | 33 | 94 | 63 | 94 |
| EG001 | Fluticasone Propionate/Salmeterol 250/50 mcg BID | Participants randomized to this arm received Fluticasone propionate/salmeterol combination product 250/50 mcg, formulated with lactose via the DISKUS inhaler one inhalation BID, one inhalation in the morning and one inhalation in the evening for 156 Weeks. Each DISKUS contained 60 doses of study medication. Participant were provided with albuterol/salbutamol as relief medication. | 5 | 92 | 32 | 92 | 72 | 92 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.1 | Systematic Assessment |
| |
| Pneumothorax traumatic | Injury, poisoning and procedural complications | MedDRA 8.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Arterial injury | Injury, poisoning and procedural complications | MedDRA 8.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Bullous lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Cholangitis acute | Hepatobiliary disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.1 | Systematic Assessment |
| |
| Cor pulmonale | Cardiac disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Coronary artery occlusion | Cardiac disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Diverticular perforation | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Heat exhaustion | Injury, poisoning and procedural complications | MedDRA 8.1 | Systematic Assessment |
| |
| Helicobacter gastritis | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.1 | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Oesophageal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.1 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 8.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.1 | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 8.1 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Procedural hypotension | Injury, poisoning and procedural complications | MedDRA 8.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Pulmonary granuloma | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Renal artery occlusion | Renal and urinary disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Renal mass | Renal and urinary disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 8.1 | Systematic Assessment |
| |
| Shock | Vascular disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 8.1 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 8.1 | Systematic Assessment |
| |
| Sudden cardiac death | General disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Troponin increased | Investigations | MedDRA 8.1 | Systematic Assessment |
| |
| Ulcer haemorrhage | General disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Whiplash injury | Injury, poisoning and procedural complications | MedDRA 8.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Candidiasis | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| 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 |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068299 | Salmeterol Xinafoate |
| C494814 | BID protein, human |
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
| Male |
|
| Black |
|
| South Asian |
|
| White/Caucasian |
|
| Week 52 |
|
|
| Week 78 |
|
|
| Week 104 |
|
|
| Week 130 |
|
|
| Week 156 |
|
|
Age split by category (40-64 years old, 65 or older). FEV1 severity based on GOLD Stage (Mild/Moderate, Severe/Very Severe). Activity based on 0-10 Physical Activity Scale (split by median, <7, >=7). Slope estimates based on treatment*time via repeated measures model with unstructured covariance. |
|
|
|