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This study evaluated the safety and efficacy of 26 weeks treatment with indacaterol, placebo or salmeterol in patients with chronic obstructive pulmonary disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Indacaterol 150 μg | Experimental | Indacaterol 150 μg once daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Placebo to Salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study. |
|
| Placebo | Placebo Comparator | Placebo to Indacaterol once daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Placebo to Salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study. |
|
| Salmeterol 50 μg | Active Comparator | Salmeterol 50 μg twice daily delivered via a proprietary dry powder inhaler in the morning and in the evening. Placebo to Indacaterol daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indacaterol 150 μg | Drug | Indacaterol 150 μg once daily (o.d) inhaled |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment | Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 hour 10 minute and 23 hour 45 minute post-dose FEV1 readings. Mixed model used baseline FEV1, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and 1 hour post inhalation of ipratropium as covariates. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| St. George's Respiratory Questionnaire (SGRQ) Total Score After 12 Weeks of Treatment | SGRQ is a health related quality of life questionnaire consisting of 76 items in three sections: symptoms, activity and impacts. The total score is 0 to 100 with a higher score indicating poorer health status. The mixed model used baseline SGRQ total score, FEV1 prior to and 30 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and one hour post inhalation of ipratropium as covariates. |
Not provided
Inclusion Criteria:
Clinical diagnosis of moderate to severe Chronic Obstructive Pulmonary Disease (COPD) as per the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2006 Guidelines (mandatory) and including:
("Post" defined as within 30 minutes of inhalation of 400 µg salbutamol)
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharma AG | Novartis Pharmaceuticals | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Edmonton | Canada | ||||
| Novartis Investigator Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22158330 | Derived | Yelensky R, Li Y, Lewitzky S, Leroy E, Hurwitz C, Rodman D, Trifilieff A, Paulding CA. A pharmacogenetic study of ADRB2 polymorphisms and indacaterol response in COPD patients. Pharmacogenomics J. 2012 Dec;12(6):484-8. doi: 10.1038/tpj.2011.54. Epub 2011 Dec 13. | |
| 21397482 | Derived | Jones PW, Mahler DA, Gale R, Owen R, Kramer B. Profiling the effects of indacaterol on dyspnoea and health status in patients with COPD. Respir Med. 2011 Jun;105(6):892-9. doi: 10.1016/j.rmed.2011.02.013. Epub 2011 Mar 11. |
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1002 participants were randomized. 3 randomized participants in the Indacaterol group and 1 randomized participant in the Salmeterol group did not receive study medication and were not included in the intent-to-treat milestone.
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| ID | Title | Description |
|---|---|---|
| FG000 | Indacaterol 150 μg | Indacaterol 150 μg once daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Placebo to Salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Salmeterol 50 μg |
| Drug |
Salmeterol 50 μg twice daily (b.i.d) delivered via a proprietary dry powder inhaler |
|
| Placebo to Indacaterol | Drug | Placebo to Indacaterol inhaled via SDDPI. |
|
| Placebo to Salmeterol | Drug | Placebo to salmeterol delivered via a proprietary dry powder inhaler |
|
| Week 12 |
| Percentage of COPD "Days of Poor Control" During 26 Weeks of Treatment | Participants rated their symptoms on a scale of 0=none to 3=severe. A Chronic Obstructive Pulmonary Disease (COPD) "day of poor control" was defined as any day in the participants diary with a score >=2 (moderate or severe) for at least 2 of 5 symptoms (cough, wheeze, production of sputum, color of sputum, breathlessness). The mixed model used baseline percentage of "days of poor control", FEV1 prior to and 30 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and one hour post inhalation of ipratropium as covariates. | Up to 26 weeks |
| Edmonton |
| Canada |
| Novartis Investigator Site | London | Canada |
| Novartis Investigator Site | Mirabel | Canada |
| Novartis Investigator Site | Montreal | Canada |
| Novartis Investigator Site | Toronto | Canada |
| Novartis Investigator site | Barranquilla | Colombia |
| Novartis Investigator Site | Bogota D.C. | Colombia |
| Novartis Investigator Site | Medellín | Colombia |
| Novartis Investigator Site | Cvikov | Czechia |
| Novartis Investigator Site | Lovosice | Czechia |
| novartis Investigator site | Novy Jocin | Czechia |
| Novartis Investigator Site | Pardubice | Czechia |
| Novartis Investigator Site | Prague | Czechia |
| Novartis Investigative Site | Žatec | Czechia |
| Novartis Investigator Site | Aalborg | Denmark |
| Novartis Investigator Site | Aarhus | Denmark |
| Novartis Investigative Site | Copenhagen | Denmark |
| Novartis Investigator Site | Copenhagen | Denmark |
| Novartis Investigator Site | Frederikssund | Denmark |
| Novartis investigator site | Hellerup | Denmark |
| Novartis Investigator site | Hvidovre | Denmark |
| Novartis investigator site | Odense | Denmark |
| Novartis Investigator Site | Roslev | Denmark |
| Novartis Investigative Site | Silkeborg | Denmark |
| Novartis Investgative Site | Søborg | Denmark |
| Novartis Investigator Site | Vaerloese | Denmark |
| Novartis Investigator Site | Hus | Finland |
| Novartis Investigator Site | Jyväskylä | Finland |
| Novartis Investigator Site | Lahti | Finland |
| Novartis Investigator Site | Oulu | Finland |
| Novartis Investigator Site | Tampere | Finland |
| Novartis Investigator Site | Turku | Finland |
| Novartis Investigative Site | Ambroise | France |
| Novartis Investigative Site | Beuvry | France |
| Novartis Investgative Site | Férolles-Attilly | France |
| Novartis Investigator Site | Nice | France |
| Novartis Investigator Site | Bad Segeberg | Germany |
| Novartis Investigator Site | Berlin | Germany |
| Novartis Investigator Site | Bielefeld | Germany |
| Novartis Investigator Site | Bochum | Germany |
| Novartis Investigator Site | Bonn | Germany |
| Novartis Investigator Site | Brühl | Germany |
| Novartis Investigator Site | Cologne | Germany |
| Novartis Investigator Site | Cottbus | Germany |
| Novartis Investigator Site | Dortmund | Germany |
| Novartis Investigator Site | Düren | Germany |
| Novartis Investigator Site | Eggenfelden | Germany |
| Novartis investigator site | Eschwege | Germany |
| Novartis Investigator Site | Forchheim | Germany |
| Novartis Investigator Site | Freudenberg | Germany |
| Novartis Investigator Site | Fürth | Germany |
| Novartis Investigator Site | Gelsenkirchen | Germany |
| Novartis Investigator Site | Gummersbach | Germany |
| Novartis Investigator Site | Hagen | Germany |
| Novartis Investigator Site | Hanover | Germany |
| Novartis Investigator Site | Kassel | Germany |
| Novartis Investigator Site | Kempten | Germany |
| Novartis Investigator Site | Landsberg am Lech | Germany |
| Novartis Investigator Site | Langenfeld | Germany |
| Novartis Investigator Site | Leipzig | Germany |
| Novartis Investigator Site | Mainz | Germany |
| Novartis Investigator Site | Munich | Germany |
| Novartis Investigator Site | München | Germany |
| Novartis Investigator Site | Neuss | Germany |
| Novartis Investigator Site | Nuremberg | Germany |
| Novartis Investigator Site | Oschersleben | Germany |
| Novartis Investigator Site | Ruhmannsfelden | Germany |
| Novartis Investigator site | Sinsheim | Germany |
| Novartis Investigator Site | Solingen | Germany |
| Novartis Investigator Site | Steinfort-borghorst | Germany |
| Novartis Investigator Site | Vilshofen | Germany |
| Novartis Investigator Site | Wallerfing | Germany |
| Novartis Investigator Site | Witten | Germany |
| Novartis Investigator Site | Budapest | Hungary |
| Novartis investigator site | Debrechen | Hungary |
| Novartis Investigator Site | Deszk | Hungary |
| Novartis Investigator Site | Mosonmagyaróvár | Hungary |
| Novartis Investigator Site | Székesfehérvár | Hungary |
| Novartis investigator site | Reykhavik | Iceland |
| Novartis Investigator Site | Chennai | India |
| Novartis Investigator Site | Coimbatore | India |
| Novartis Investigator Site | Goā | India |
| Novartis Investigator Site | Hyderabad | India |
| Novartis Investigator Site | Jaipur | India |
| Novartis Investigator Site | Kerala | India |
| Novartis Investigator Site | Mangalore | India |
| Novartis Investigator Site | Mumbai | India |
| Novartis Investigator Site | Vellore | India |
| Novartis Investigator Site | Ancona | Italy |
| Novartis Investigator Site | Arenzano | Italy |
| Novartis Investigative Site | Ascoli Piceno | Italy |
| Novartis Investigator Site | Brescia | Italy |
| Novartis Investigator Site | Cagliari | Italy |
| Novartis investigator site | Chieti | Italy |
| Novartis Investigator Site | Ferrara | Italy |
| Novartis Investigator Site | Milan | Italy |
| Novartis Investigator Site | Milan | Italy |
| Novartis Investigator Site | Orbassano | Italy |
| Novartis Investigator Site | Palermo | Italy |
| Novartis Investigator Site | Reggio Emilia | Italy |
| Novartis Investigator Site | Rome | Italy |
| Novartis Investigator Site | Sexten | Italy |
| Novartis Investigator Site | Siena | Italy |
| Novartis Investigator Site | Terni | Italy |
| Novartis Investigator Site | Callao | Peru |
| Novartis Investigator Site | Miraflores | Peru |
| Novartis Investigator Site | San Borja | Peru |
| Novartis Investigator Site | San Isidro | Peru |
| Novartis Investigator Site | San Martín de Porres | Peru |
| Novartis Investigator Site | Surco | Peru |
| Novartis Investigator Site | Kazan' | Russia |
| Novartis Investigator Site | Moscow | Russia |
| Novartis Investigator Site | Saint Petersburg | Russia |
| Novartis Investigator Site | Samara | Russia |
| Novartis Investigator Site | Yaroslavl | Russia |
| Novartis Investigator Site | Yekaterinburg | Russia |
| Novartis Investigator Site | Bardejov | Slovakia |
| Novartis Investigator Site | Bratislava | Slovakia |
| Novartis Investigator Site | Košice | Slovakia |
| Novartis Investigator Site | Kovice | Slovakia |
| Novartis Investigator Site | Spišská Nová Ves | Slovakia |
| Novartis Investigator Site | Changhua | Taiwan |
| Novartis Investigator Site | Kaohsiung City | Taiwan |
| Novartis Investigator Site | Kaohusing | Taiwan |
| Novartis Investigator Site | Lin-ko | Taiwan |
| Novartis Investigator Site | Taichung | Taiwan |
| Novartis Investigator Site | Taipei | Taiwan |
| 21227674 | Derived | Worth H, Chung KF, Felser JM, Hu H, Rueegg P. Cardio- and cerebrovascular safety of indacaterol vs formoterol, salmeterol, tiotropium and placebo in COPD. Respir Med. 2011 Apr;105(4):571-9. doi: 10.1016/j.rmed.2010.11.027. Epub 2011 Jan 11. |
| FG001 | Salmeterol 50 μg | Salmeterol 50 μg twice daily delivered via a proprietary dry powder inhaler in the morning and in the evening. Placebo to Indacaterol daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study. |
| FG002 | Placebo | Placebo to indacaterol inhaled via SDDPI. Placebo to salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study. |
| Intent-to-treat: Received Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Indacaterol 150 μg | Indacaterol 150 μg once daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Placebo to Salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study. |
| BG001 | Salmeterol 50 μg | Salmeterol 50 μg twice daily delivered via a proprietary dry powder inhaler in the morning and in the evening. Placebo to Indacaterol daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study. |
| BG002 | Placebo | Placebo to indacaterol inhaled via SDDPI. Placebo to salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study. |
| BG003 | 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 | All baseline measures are based on the intent-to-treat population that included all randomized participants who received at least one dose of study medication. | Mean | Standard Deviation | 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 | Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment | Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 hour 10 minute and 23 hour 45 minute post-dose FEV1 readings. Mixed model used baseline FEV1, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and 1 hour post inhalation of ipratropium as covariates. | Intent-to-treat population included all randomized participants who received at least one dose of study medication. The end point was analyzed only for those participants who had Trough FEV1 data at week 12. Missing data were imputed using Last Observation carried Forward (LOCF). | Posted | Least Squares Mean | Standard Error | Liters | Week 12 |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | St. George's Respiratory Questionnaire (SGRQ) Total Score After 12 Weeks of Treatment | SGRQ is a health related quality of life questionnaire consisting of 76 items in three sections: symptoms, activity and impacts. The total score is 0 to 100 with a higher score indicating poorer health status. The mixed model used baseline SGRQ total score, FEV1 prior to and 30 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and one hour post inhalation of ipratropium as covariates. | Intent-to-treat population included all randomized participants who received at least one dose of study medication. The endpoint was analyzed only for those participants who had SGRQ data at week 12. Missing data were imputed using Last Observation carried Forward (LOCF). | Posted | Least Squares Mean | Standard Error | Score on a scale | Week 12 |
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of COPD "Days of Poor Control" During 26 Weeks of Treatment | Participants rated their symptoms on a scale of 0=none to 3=severe. A Chronic Obstructive Pulmonary Disease (COPD) "day of poor control" was defined as any day in the participants diary with a score >=2 (moderate or severe) for at least 2 of 5 symptoms (cough, wheeze, production of sputum, color of sputum, breathlessness). The mixed model used baseline percentage of "days of poor control", FEV1 prior to and 30 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and one hour post inhalation of ipratropium as covariates. | Intent-to-treat population included all randomized participants who received at least one dose of study medication. The endpoint was analyzed only for those participants who had data for this outcome measure. | Posted | Least Squares Mean | Standard Error | Percentage of days | Up to 26 weeks |
|
26 weeks
Safety population consisting of all participants who received at least one dose of study medication.
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 | Indacaterol 150 μg | Indacaterol 150 μg once daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Placebo to Salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study. | 29 | 330 | 69 | 330 | ||
| EG001 | Salmeterol 50 μg | Salmeterol 50 μg twice daily delivered via a proprietary dry powder inhaler in the morning and in the evening. Placebo to Indacaterol daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study. | 19 | 333 | 68 | 333 | ||
| EG002 | Placebo | Placebo to Indacaterol once daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Placebo to Salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study. | 26 | 335 | 71 | 335 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Bundle branch block left | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cor pulmonale acute | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Sick sinus syndrome | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Tricuspid valve incompetence | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Goitre | Endocrine disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Upper respiratory tract infection bacterial | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Subdural haemorrhage | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Traumatic intracranial haemorrhage | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Adenocarcinoma pancreas | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Diffuse large B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Brachial plexopathy | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Alcoholism | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Renal failure chronic | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. any publications from a single-site are postponed until the publication of the pooled date (i.e., data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
| 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 |
|---|---|
| C510790 | indacaterol |
| D000068299 | Salmeterol Xinafoate |
| ID | Term |
|---|---|
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
Not provided
Not provided
| Male |
|
| OG002 | Placebo | Placebo to indacaterol inhaled via SDDPI. Placebo to salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study. |
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| OG002 | Placebo | Placebo to indacaterol inhaled via SDDPI. Placebo to salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study. |
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