Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2011-003732-31 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to compare the effectiveness and safety of indacaterol with salmeterol /fluticasone propionate treatment in patients with moderate chronic obstructive pulmonary disease who, on entry to the study are being treated with salmeterol /fluticasone propionate.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Indacaterol | Experimental | Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®) |
|
| Salmeterol/fluticasone propionate | Active Comparator | Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indacaterol | Drug | Indacaterol is delivered via a SDDPI. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Trough Forced Expiratory Volume in One Second (FEV1) at 12 Weeks (Imputed With LOCF): Treatment Comparisons | Spirometry conducted to internationally accepted standards. Trough FEV1 defined as the mean of the FEV1 measurements at 23 h 10 min and 23 h 45 min post the Day 84 morning dose. The primary variable (imputed with last observation carried forward) will be analysed using a mixed model for the Per Protocol Set (PPS). The model will contain treatment as a fixed effect with the baseline FEV1 measurement, FEV1 prior to inhalation and FEV1 10-15 min post inhalation of salbutamol (components of reversibility at Visit 1) as covariates. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Trough FEV1 (L) at Week 26 (Imputed With LOCF): Treatment Comparisons | Trough FEV1 is defined as the average of the 23 h 10 min and the 23 h 45 min values taken in the clinic at Visit 11. | 26 weeks |
| FEV1 (L) at Individual Time Points After 12 Weeks Treatment: Treatment Comparisons |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Caba | Argentina | C1119ACN | Argentina | ||
| Novartis Investigative Site |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Indacaterol | Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®) |
| FG001 | Salmeterol/Fluticasone Propionate |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Salmeterol |
| Drug |
Salmeterol/fluticasone is delivered via a MDDPI |
|
FEV1 at each time point, for each visit, will be analyzed using the same mixed model as specified for the primary analysis. Least squares means will be displayed by treatment group. |
| 12 weeks |
| FEV1 (L) at Individual Time Points After 26 Weeks Treatment: Treatment Comparisons | FEV1 at each time point, for each visit, will be analyzed using the same mixed model as specified for the primary analysis. Least squares means will be displayed by treatment group . | 26 weeks |
| FVC Over 26 Weeks of Treatment | FVC at each time point, for each visit, will be analyzed using the same mixed model as specified for the primary analysis. Least squares means will be displayed by treatment group. | 12 and 26 weeks |
| Analysis of AUC (5 Min - 4 h) for FEV1 (L) at Week 12 and Week 26: Treatment Comparison | The standardized (with respect to the length of time) AUC for FEV1 will be calculated between 5 min and 4 h post morning dose as the sum of trapezoids divided by the length of time at Day 84 (Visit 6) and Day 182 (Visit 10). Scheduled (not actual) time points are to be used. FEV1 measurements taken within 6 h of rescue use will be set to missing before the standardized AUC is calculated. | 12 and 26 weeks |
| TDI Focal Score at Week 12 and Week 26: Treatment Comparisons | The Transition Dyspnea Index (TDI) total score after 12 and 26 weeks of treatment will be analyzed using the same mixed model as specified for the primary analysis with the Baseline Dyspnea Index (BDI) total score as the baseline.Total score ranging - 9 to + 9. The lower the score, the more deterioration in severity of dyspnea. One additional option in each category, which does not contribute to the score, allows for circumstances in which impairment is due to reasons other than dyspnea. | 12 and 26 weeks |
| Number of COPD Exacerbations Per Patient Over 26 Weeks: Treatment Comparisons (Without Imputation; Full Analysis Set) | The number of exacerbations during the 26 week treatment period will be analyzed using a generalized linear model assuming a negative binomial distribution. | 26 weeks |
| Mean Daily Number of Puffs of Rescue Medication Used Over 26 Weeks of Treatment | The mean daily number of puffs of rescue medication taken by the patient will be derived. If the number of puffs is missing for part of the day (either morning or evening) then a half day will be used in the denominator. Rescue medication data recorded during the 14 day run-in period will be used to calculate the baseline. The mean change from baseline in the daily number of puffs of rescue medication will be analyzed using the same mixed model as specified for the primary analysis, with the baseline FEV1 replaced with the baseline daily rescue use. | 12 and 26 weeks |
| Rescue Medication Use Over 26 Weeks: Percentage of 'Days With no Rescue Use' | A 'day with no rescue use' is defined from diary data as any day where the patient has taken no puffs of rescue medication. The percentage of 'days with no rescue use' will be derived and analyzed as for the percentage of 'nights with no nighttime awakenings'. | 26 weeks |
| St Georges Respiratory Questionnaire for COPD | A Total and three component scores are calculated: Symptoms; Activity; Impacts. Each component of the questionnaire is scored separately:The score for each component is calculated separately by dividing the summed weights by the maximum possible weight for that component and expressing the result as a percentage: Score = 100 x Summed weights from all positive items in that component divided by Sum of weights for all items in that component The Total score is calculated in similar way: Score = 100 x Summed weights from all positive items in the questionnaire divided by Sum of weights for all items in the questionnaire Sum of maximum possible weights for each component and Total: Symptoms 566.2 Activity 982.9 Impacts 1652.8 Total (sum of maximum for all three components) 3201.9 The proportion of patients who achieve a clinically important improvement of at least 4 units in the total SGRQ will be analyzed. The higher the score the more symptoms of disease are present. | 12 and 26 weeks |
| Buenos Aires |
| Buenos Aires |
| 1425 |
| Argentina |
| Novartis Investigative Site | Buenos Aires | Buenos Aires | B6500EZL | Argentina |
| Novartis Investigative Site | Buenos Aires | Buenos Aires | C1120AAC | Argentina |
| Novartis Investigative Site | Buenos Aires | Buenos Aires | C1125ABE | Argentina |
| Novartis Investigative Site | C A B A | Buenos Aires | Argentina |
| Novartis Investigative Site | Caba | Buenos Aires | 1028 | Argentina |
| Novartis Investigative Site | Caba | Buenos Aires | 1122 | Argentina |
| Novartis Investigative Site | Caba | Buenos Aires | 1209 | Argentina |
| Novartis Investigative Site | Caba | Buenos Aires | 1425 | Argentina |
| Novartis Investigative Site | Caba | Buenos Aires | B8000XAV | Argentina |
| Novartis Investigative Site | Caba | Buenos Aires | C1056ABJ | Argentina |
| Novartis Investigative Site | Caba | Buenos Aires | C1122AAK | Argentina |
| Novartis Investigative Site | Caba | Buenos Aires | C1280AEB | Argentina |
| Novartis Investigative Site | Caba | Buenos Aires | C1414AIF | Argentina |
| Novartis Investigative Site | Caba | Buenos Aires | C1425DQI | Argentina |
| Novartis Investigative Site | La Plata | Buenos Aires | 1900 | Argentina |
| Novartis Investigative Site | Mar del Plata | Buenos Aires | 7600 | Argentina |
| Novartis Investigative Site | Mar del Plata | Buenos Aires | B7600DHK | Argentina |
| Novartis Investigative Site | Quilmes | Buenos Aires | B1878FNR | Argentina |
| Novartis Investigative Site | Córdoba | Córdoba Province | X5016KEH | Argentina |
| Novartis Investigative Site | Villa María | Córdoba Province | X5900JKA | Argentina |
| Novartis Investigative Site | Concepción del Uruguay | Entre Ríos Province | 3260 | Argentina |
| Novartis Investigative Site | Mendoza | Mendoza Province | 5500 | Argentina |
| Novartis Investigative Site | Mendoza | Mendoza Province | M5500CBA | Argentina |
| Novartis Investigative Site | Santa Fe | Rosario | S2000DBS | Argentina |
| Novartis Investigative Site | Salta | Salta Province | 4000 | Argentina |
| Novartis Investigative Site | Rosario | Santa Fe Province | S2000CXH | Argentina |
| Novartis Investigative Site | Santa Fe | Santa Fe Province | S3000FIL | Argentina |
| Novartis Investigative Site | San Miguel de Tucumán | Tucumán Province | 4000 | Argentina |
| Novartis Investigative Site | San Miguel de Tucumán | Tucumán Province | T4000IFL | Argentina |
| Novartis Investigative Site | Buenos Aires | C1440BRR | Argentina |
| Novartis Investigative Site | Bogota | Cundinamarca | Colombia |
| Novartis Investigative Site | Barranquilla | Colombia |
| Novartis Investigative Site | Bogotá | Colombia |
| Novartis Investigative Site | Acquaviva delle Fonti | BA | 70021 | Italy |
| Novartis Investigative Site | Cassano delle Murge | BA | 70020 | Italy |
| Novartis Investigative Site | Treviglio | BG | 24047 | Italy |
| Novartis Investigative Site | Bologna | BO | 40138 | Italy |
| Novartis Investigative Site | Caserta | CE | 81100 | Italy |
| Novartis Investigative Site | Forlì | FC | 47100 | Italy |
| Novartis Investigative Site | Cona | FE | 44100 | Italy |
| Novartis Investigative Site | Foggia | FG | 71100 | Italy |
| Novartis Investigative Site | Cassino | FR | 03043 | Italy |
| Novartis Investigative Site | Genova | GE | 16132 | Italy |
| Novartis Investigative Site | Messina | ME | 98158 | Italy |
| Novartis Investigative Site | Milan | MI | 20123 | Italy |
| Novartis Investigative Site | Milan | MI | 20126 | Italy |
| Novartis Investigative Site | Milan | MI | 20142 | Italy |
| Novartis Investigative Site | Sesto San Giovanni | Mi | 20099 | Italy |
| Novartis Investigative Site | Cittadella | PD | 35013 | Italy |
| Novartis Investigative Site | Pisa | PI | 56124 | Italy |
| Novartis Investigative Site | Pordenone | PN | 33170 | Italy |
| Novartis Investigative Site | Parma | PR | 43100 | Italy |
| Novartis Investigative Site | Pavia | PV | 27100 | Italy |
| Novartis Investigative Site | Salerno | SA | 84131 | Italy |
| Novartis Investigative Site | Cuasso al Monte | VA | 21050 | Italy |
| Novartis Investigative Site | Tradate | VA | 21049 | Italy |
| Novartis Investigative Site | Negrar | VR | 37024 | Italy |
| Novartis Investigative Site | Verona | VR | 37126 | Italy |
| Novartis Investigative Site | Wilayah Persekutuan | Kuala Lumpur | 50590 | Malaysia |
| Novartis Investigative Site | Kuching | Sarawak | 93586 | Malaysia |
| Novartis Investigative Site | Pulau Pinang | 10990 | Malaysia |
| Novartis Investigative Site | Guadalajara | Jalisco | 44100 | Mexico |
| Novartis Investigative Site | Mexico City | Mexico City | 11950 | Mexico |
| Novartis Investigative Site | Mexico City | Mexico City | 14050 | Mexico |
| Novartis Investigative Site | Monterrey | Nuevo León | 64718 | Mexico |
| Novartis Investigative Site | Querétaro City | Querétaro | 76000 | Mexico |
| Novartis Investigative Site | San Luis Potosí City | San Luis Potosí | 78200 | Mexico |
| Novartis Investigative Site | Breda | Netherlands | 4819 EV | Netherlands |
| Novartis Investigative Site | Helmond | Netherlands | 5707 HA | Netherlands |
| Novartis Investigative Site | Rotterdam | 3045 PM | Netherlands |
| Novartis Investigative Site | Loja | Andalusia | 18300 | Spain |
| Novartis Investigative Site | Sanlúcar de Barrameda | Andalusia | 11540 | Spain |
| Novartis Investigative Site | Valladolid | Castille and León | 47011 | Spain |
| Novartis Investigative Site | Barcelona | Catalonia | 08024 | Spain |
| Novartis Investigative Site | Canet de Mar | Catalonia | 08360 | Spain |
| Novartis Investigative Site | Corbera de Llobregat | Catalonia | 08757 | Spain |
| Novartis Investigative Site | Lleida | Catalonia | 25198 | Spain |
| Novartis Investigative Site | Madrid | Madrid | 28029 | Spain |
| Novartis Investigative Site | Pozuelo de Alarcón | Madrid | 28223 | Spain |
| Novartis Investigative Site | Muenchenstein | Switzerland | 4241 | Switzerland |
| Novartis Investigative Site | Basel | 4031 | Switzerland |
| Novartis Investigative Site | Biel | 2500 | Switzerland |
| Novartis Investigative Site | Gossau | 9200 | Switzerland |
| Novartis Investigative Site | Newcastle upon Tyne | Newcastle-upon-Tyne | NE7 7DN | United Kingdom |
| Novartis Investigative Site | Dundee | Perthshire | DD1 2BU | United Kingdom |
| Novartis Investigative Site | Hants | Southampton | SO9 5NY | United Kingdom |
| Novartis Investigative Site | Bradford | BD9 6RJ | United Kingdom |
| Novartis Investigative Site | Chester | CH2 1UL | United Kingdom |
| Novartis Investigative Site | East Yorkshire | HU16 5JQ | United Kingdom |
| Novartis Investigative Site | Kettering | NN16 8UZ | United Kingdom |
| Novartis Investigative Site | Lancaster | LA1 4RP | United Kingdom |
| Novartis Investigative Site | Surrey | KT16 0PZ | United Kingdom |
Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Indacaterol | Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®) |
| BG001 | Salmeterol/Fluticasone Propionate | Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.) |
| 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 |
|
| 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 One Second (FEV1) at 12 Weeks (Imputed With LOCF): Treatment Comparisons | Spirometry conducted to internationally accepted standards. Trough FEV1 defined as the mean of the FEV1 measurements at 23 h 10 min and 23 h 45 min post the Day 84 morning dose. The primary variable (imputed with last observation carried forward) will be analysed using a mixed model for the Per Protocol Set (PPS). The model will contain treatment as a fixed effect with the baseline FEV1 measurement, FEV1 prior to inhalation and FEV1 10-15 min post inhalation of salbutamol (components of reversibility at Visit 1) as covariates. | full analysis set | Posted | Least Squares Mean | Standard Error | Liters | 12 weeks |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Trough FEV1 (L) at Week 26 (Imputed With LOCF): Treatment Comparisons | Trough FEV1 is defined as the average of the 23 h 10 min and the 23 h 45 min values taken in the clinic at Visit 11. | Full analysis set | Posted | Least Squares Mean | Standard Error | Liters | 26 weeks |
|
| |||||||||||||||||||||||||||||
| Secondary | FEV1 (L) at Individual Time Points After 12 Weeks Treatment: Treatment Comparisons | FEV1 at each time point, for each visit, will be analyzed using the same mixed model as specified for the primary analysis. Least squares means will be displayed by treatment group. | Full analysis set | Posted | Least Squares Mean | Standard Error | Liters | 12 weeks |
|
| |||||||||||||||||||||||||||||
| Secondary | FEV1 (L) at Individual Time Points After 26 Weeks Treatment: Treatment Comparisons | FEV1 at each time point, for each visit, will be analyzed using the same mixed model as specified for the primary analysis. Least squares means will be displayed by treatment group . | Full analysis set | Posted | Least Squares Mean | Standard Error | Liters | 26 weeks |
|
| |||||||||||||||||||||||||||||
| Secondary | FVC Over 26 Weeks of Treatment | FVC at each time point, for each visit, will be analyzed using the same mixed model as specified for the primary analysis. Least squares means will be displayed by treatment group. | Full analysis set | Posted | Least Squares Mean | Standard Error | Liters | 12 and 26 weeks |
|
| |||||||||||||||||||||||||||||
| Secondary | Analysis of AUC (5 Min - 4 h) for FEV1 (L) at Week 12 and Week 26: Treatment Comparison | The standardized (with respect to the length of time) AUC for FEV1 will be calculated between 5 min and 4 h post morning dose as the sum of trapezoids divided by the length of time at Day 84 (Visit 6) and Day 182 (Visit 10). Scheduled (not actual) time points are to be used. FEV1 measurements taken within 6 h of rescue use will be set to missing before the standardized AUC is calculated. | Full analysis set | Posted | Least Squares Mean | Standard Error | Liters | 12 and 26 weeks |
|
| |||||||||||||||||||||||||||||
| Secondary | TDI Focal Score at Week 12 and Week 26: Treatment Comparisons | The Transition Dyspnea Index (TDI) total score after 12 and 26 weeks of treatment will be analyzed using the same mixed model as specified for the primary analysis with the Baseline Dyspnea Index (BDI) total score as the baseline.Total score ranging - 9 to + 9. The lower the score, the more deterioration in severity of dyspnea. One additional option in each category, which does not contribute to the score, allows for circumstances in which impairment is due to reasons other than dyspnea. | Posted | Least Squares Mean | Standard Error | Units on a scale | 12 and 26 weeks |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of COPD Exacerbations Per Patient Over 26 Weeks: Treatment Comparisons (Without Imputation; Full Analysis Set) | The number of exacerbations during the 26 week treatment period will be analyzed using a generalized linear model assuming a negative binomial distribution. | Posted | Number | participants | 26 weeks |
|
| |||||||||||||||||||||||||||||||
| Secondary | Mean Daily Number of Puffs of Rescue Medication Used Over 26 Weeks of Treatment | The mean daily number of puffs of rescue medication taken by the patient will be derived. If the number of puffs is missing for part of the day (either morning or evening) then a half day will be used in the denominator. Rescue medication data recorded during the 14 day run-in period will be used to calculate the baseline. The mean change from baseline in the daily number of puffs of rescue medication will be analyzed using the same mixed model as specified for the primary analysis, with the baseline FEV1 replaced with the baseline daily rescue use. | Posted | Mean | Standard Deviation | number of puffs | 12 and 26 weeks |
|
| ||||||||||||||||||||||||||||||
| Secondary | Rescue Medication Use Over 26 Weeks: Percentage of 'Days With no Rescue Use' | A 'day with no rescue use' is defined from diary data as any day where the patient has taken no puffs of rescue medication. The percentage of 'days with no rescue use' will be derived and analyzed as for the percentage of 'nights with no nighttime awakenings'. | Full Analysis Set | Posted | Least Squares Mean | Standard Error | % of Days | 26 weeks |
|
| |||||||||||||||||||||||||||||
| Secondary | St Georges Respiratory Questionnaire for COPD | A Total and three component scores are calculated: Symptoms; Activity; Impacts. Each component of the questionnaire is scored separately:The score for each component is calculated separately by dividing the summed weights by the maximum possible weight for that component and expressing the result as a percentage: Score = 100 x Summed weights from all positive items in that component divided by Sum of weights for all items in that component The Total score is calculated in similar way: Score = 100 x Summed weights from all positive items in the questionnaire divided by Sum of weights for all items in the questionnaire Sum of maximum possible weights for each component and Total: Symptoms 566.2 Activity 982.9 Impacts 1652.8 Total (sum of maximum for all three components) 3201.9 The proportion of patients who achieve a clinically important improvement of at least 4 units in the total SGRQ will be analyzed. The higher the score the more symptoms of disease are present. | Full Analysis set | Posted | Least Squares Mean | Standard Error | scores on a scale | 12 and 26 weeks |
|
Not provided
Not provided
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 | Indacaterol 150 μg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®) | 5 | 293 | 70 | 293 | ||
| EG001 | Salmeterol/Fluticasone | Salmeterol 50 μg /fluticasone propionate 500 μg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.) | 17 | 288 | 85 | 288 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Duodenitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Mesothelioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Neurilemmoma benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pneumothorax spontaneous | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Peripheral artery thrombosis | 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 data (ie, 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 |
|
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