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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-023621-37 | EudraCT Number |
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The purpose of this study is to compare the efficacy and safety/tolerability of indacaterol and glycopyrronium (QVA149) (fixed-dose combination) with fluticasone/salmeterol over a 26-week period in patients with moderate to severe COPD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QVA149 | Experimental | Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol. |
|
| fluticasone/salmeterol | Active Comparator | Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| indacaterol and glycopyrronium (QVA149) | Drug | QVA149 capsules delivered via dry powder inhaler (SDDPI), once daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12 | Forced Expiratory Volume in one second (FEV1) was calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. FEV1 was normalized by 12 hours (divided by time). This outcome measures absolute values at week 26. Results are obtained from linear mixed model. | Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Standardized Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12 Hours | Standardized Forced Expiratory Volume in 1 Second (FEV1) was measured with spirometry conducted according to internationally accepted standards. Measurements were made between 0 and 12 hours after treatment. FEV1 was normalized by 12 hours (divided by time). This outcome measures absolute values at week 12. Results are obtained from linear mixed model. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Malmedy | Belgium | 4960 | Belgium | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24321804 | Derived | Vogelmeier CF, Bateman ED, Pallante J, Alagappan VK, D'Andrea P, Chen H, Banerji D. Efficacy and safety of once-daily QVA149 compared with twice-daily salmeterol-fluticasone in patients with chronic obstructive pulmonary disease (ILLUMINATE): a randomised, double-blind, parallel group study. Lancet Respir Med. 2013 Mar;1(1):51-60. doi: 10.1016/S2213-2600(12)70052-8. Epub 2012 Dec 6. |
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A total of 523 patients were randomized. A total of 522 patients (99.8%) were included in the Full analysis Set (FAS) and Safety set. One patient was excluded who was randomized in error and did not receive study medication.
All eligible patients were randomized to one of the 2 arms in a 1:1 ratio for 26 weeks of treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | QVA149 | Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol. |
| FG001 | Fluticasone/Salmeterol | Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo to fluticasone/salmeterol | Drug | Placebo to fluticasone/salmeterol delivered via Accuhaler® device, twice daily. |
|
| fluticasone/salmeterol | Drug | Fluticasone/salmeterol dry inhalation powder delivered via Accuhaler® device, twice daily. |
|
| Placebo to indacaterol and glycopyrronium (QVA149) | Drug | Placebo to QVA149 delivered via dry powder inhaler (SDDPI), once daily |
|
| Week 12 |
| Forced Vital Capacity at All-time Points (Week 12) | Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed via spirometry. A positive change from baseline in FVC indicates improvement in lung function. This outcome measures absolute values at -45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose week 12. Results are obtained from linear mixed model. | -45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose on week 12 |
| Forced Vital Capacity at All-time Points (Week 26) | Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed via spirometry. A positive change from baseline in FVC indicates improvement in lung function. This outcome measures absolute values at -45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose on week 26. Results are obtained from linear mixed model. | -45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose on week 26 |
| Focal Score of the Transitional Dyspnea Index (TDI) | Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement. | 12 weeks and 26 weeks |
| Total Score of the St. George's Respiratory Questionnaire (SGRQ-C) | The total score of the St. George's Respiratory Questionnaire (SGRQ-C) is a health related quality of life questionnaire consisting of 51 items in three components: symptoms, activity, and impacts. The lowest possible value is zero and the highest 100. Higher values correspond to greater impairment in quality of life. | 12 weeks and 26 weeks |
| Mean Change From Baseline in Daily Number of Puffs of Rescue Medication | Participants maintained a diary to record the daily number of puffs of rescue medication used to treat COPD symptoms. | Baseline, 12 weeks and 26 weeks |
| Change From Baseline in Symptom Scores Reported Using the Ediary | Participants maintained an ediary to record daily symptom scores (AM and PM) over 12 weeks and 26 weeks of treatment. This analysis compares the mean symptom scores over 12 weeks and 26 weeks compared to baseline. The diary records morning and evening daily clinical symptoms including cough, wheezing, shortness of breath, sputum volume, sputum purulence, night time awakenings and rescue medication use. Scale ranges: ranges are 0 to 3 with varying scale descriptions that pertain to the question being asked. 0 is the minimum score = "none" or "No symptoms" or "never" or "No"
| 12 weeks and 26 weeks |
| Inspiratory Capacity (IC) at All-time Points (12 Weeks) | After 12 weeks of treatment, Inspiratory Capacity (IC) was measured via spirometry, conducted according to internationally accepted standards. The mean of 3 acceptable measurements was calculated and reported in liters. | 12 weeks |
| Inspiratory Capacity (IC) at All-time Points (26 Weeks) | After 26 weeks of treatment, Inspiratory Capacity (IC) was measured via spirometry, conducted according to internationally accepted standards. The mean of 3 acceptable measurements was calculated and reported in liters. | 26 weeks |
| Number of Participants With Adverse Events | The assessment of safety was based on Adverse Events. A summary of adverse events is presented with this outcome, additional details are provided in Adverse Events Section. | 26 weeks |
| Luxembourg |
| Luxembourg |
| 1210 |
| Belgium |
| Novartis Investigative Site | Aalst | 9300 | Belgium |
| Novartis Investigative Site | Brussels | 1000 | Belgium |
| Novartis Investigative Site | Hasselt | 3500 | Belgium |
| Novartis Investigative Site | Jambes | 5100 | Belgium |
| Novartis Investigative Site | Jette | 1090 | Belgium |
| Novartis Investigative Site | Cvikov | Czech Republic | 471 54 | Czechia |
| Novartis Investigative Site | Jindřichův Hradec | Czech Republic | 377 01 | Czechia |
| Novartis Investigative Site | Mělník | Czech Republic | 276 01 | Czechia |
| Novartis Investigative Site | Pardubice | Czech Republic | 530 09 | Czechia |
| Novartis Investigative Site | Prague | Czech Republic | 108 00 | Czechia |
| Novartis Investigative Site | Prague | Czech Republic | 130 00 | Czechia |
| Novartis Investigative Site | Teplice | Czech Republic | 415 01 | Czechia |
| Novartis Investigative Site | Kyjov | CZE | 697 70 | Czechia |
| Novartis Investigative Site | Tartu | Estonia | 51014 | Estonia |
| Novartis Investigative Site | Tallinn | 13419 | Estonia |
| Novartis Investigative Site | Berlin | Germany | 10117 | Germany |
| Novartis Investigative Site | Berlin | Germany | 14050 | Germany |
| Novartis Investigative Site | Leipzig | Germany | 04207 | Germany |
| Novartis Investigative Site | Saarbrücken | Germany | 66111 | Germany |
| Novartis Investigative Site | Aschaffenburg | 63739 | Germany |
| Novartis Investigative Site | Bad Wörishofen | 86825 | Germany |
| Novartis Investigative Site | Bamberg | 96049 | Germany |
| Novartis Investigative Site | Berlin | 13057 | Germany |
| Novartis Investigative Site | Berlin | 13086 | Germany |
| Novartis Investigative Site | Berlin | 13507 | Germany |
| Novartis Investigative Site | Berlin | 13581 | Germany |
| Novartis Investigative Site | Berlin | 14050 | Germany |
| Novartis Investigative Site | Berlin | D-12165 | Germany |
| Novartis Investigative Site | Bielefeld | 33617 | Germany |
| Novartis Investigative Site | Bochum | 44787 | Germany |
| Novartis Investigative Site | Bonn | 53123 | Germany |
| Novartis Investigative Site | Borstel | 23845 | Germany |
| Novartis Investigative Site | Düren | 52349 | Germany |
| Novartis Investigative Site | Eschwege | 37269 | Germany |
| Novartis Investigative Site | Frankfurt | 60596 | Germany |
| Novartis Investigative Site | Freudenberg | 57258 | Germany |
| Novartis Investigative Site | Fulda | 36039 | Germany |
| Novartis Investigative Site | Fürstenwalde | 15517 | Germany |
| Novartis Investigative Site | Gelsenkirchen | 45879 | Germany |
| Novartis Investigative Site | Göttingen | 37075 | Germany |
| Novartis Investigative Site | Gummersbach | 51643 | Germany |
| Novartis Investigative Site | Güstrow | 18273 | Germany |
| Novartis Investigative Site | Hagen | 59065 | Germany |
| Novartis Investigative Site | Hamburg | 20253 | Germany |
| Novartis Investigative Site | Hamburg | 20354 | Germany |
| Novartis Investigative Site | Hamburg | 20357 | Germany |
| Novartis Investigative Site | Hanover | 30167 | Germany |
| Novartis Investigative Site | Hildesheim | 31134 | Germany |
| Novartis Investigative Site | Lübeck | 23558 | Germany |
| Novartis Investigative Site | München | 80539 | Germany |
| Novartis Investigative Site | Oschersleben | 39387 | Germany |
| Novartis Investigative Site | Ratingen | 40878 | Germany |
| Novartis Investigative Site | Rheine | 48431 | Germany |
| Novartis Investigative Site | Schwerte | 58239 | Germany |
| Novartis Investigative Site | Solingen | 42651 | Germany |
| Novartis Investigative Site | Ulm | 89081 | Germany |
| Novartis Investigative Site | Wissen | 57537 | Germany |
| Novartis Investigative Site | Cegléd | Hungary | 2700 | Hungary |
| Novartis Investigative Site | Debrecen | Hungary | 4032 | Hungary |
| Novartis Investigative Site | Szarvas | Hungary | 5540 | Hungary |
| Novartis Investigative Site | Budapest | 1191 | Hungary |
| Novartis Investigative Site | Eger | 3300 | Hungary |
| Novartis Investigative Site | Gödöllő | 2100 | Hungary |
| Novartis Investigative Site | Mosonmagyaróvár | 9200 | Hungary |
| Novartis Investigative Site | Szeged | 6770 | Hungary |
| Novartis Investigative Site | Törökbálint | 2045 | Hungary |
| Novartis Investigative Site | Alytus | LT-62114 | Lithuania |
| Novartis Investigative Site | Kaunas | 44320 | Lithuania |
| Novartis Investigative Site | Klaipėda | 92288 | Lithuania |
| Novartis Investigative Site | Klaipėda | LT-92231 | Lithuania |
| Novartis Investigative Site | Utena | LT-28151 | Lithuania |
| Novartis Investigative Site | Vilnius | 06001 | Lithuania |
| Novartis Investigative Site | Ålesund | 6017 | Norway |
| Novartis Investigative Site | Kongsvinger | 2212 | Norway |
| Novartis Investigative Site | Skedsmokorset | 2020 | Norway |
| Novartis Investigative Site | Stavanger | 4005 | Norway |
| Novartis Investigative Site | Trondheim | 7006 | Norway |
| Novartis Investigative Site | Wŏnju | Gangwon-do | 220-701 | South Korea |
| Novartis Investigative Site | Seoul | Seoul | 130-709 | South Korea |
| Novartis Investigative Site | Daegu | 705-717 | South Korea |
| Novartis Investigative Site | Seoul | 100-032 | South Korea |
| Novartis Investigative Site | Seoul | 130-702 | South Korea |
| Novartis Investigative Site | Seoul | 143-729 | South Korea |
| Novartis Investigative Site | Seoul | 152-703 | South Korea |
| Novartis Investigative Site | Alicante | Alicante | 03114 | Spain |
| Novartis Investigative Site | Barcelona | Catalonia | 08025 | Spain |
| Novartis Investigative Site | Sabadell | Catalonia | 08208 | Spain |
| Novartis Investigative Site | Sant Boi de Llobregat | Catalonia | 08830 | Spain |
| Novartis Investigative Site | Pamplona | Navarre | 31008 | Spain |
| Novartis Investigative Site | Oviedo | Principality of Asturias | 33006 | Spain |
| Novartis Investigative Site | Valladolid | Valladolid | 47011 | Spain |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | QVA149 | Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol. |
| BG001 | Fluticasone/Salmeterol | Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149). |
| 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 | Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12 | Forced Expiratory Volume in one second (FEV1) was calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. FEV1 was normalized by 12 hours (divided by time). This outcome measures absolute values at week 26. Results are obtained from linear mixed model. | The Full Analysis Set (FAS) included all randomized patients who received at least one dose of study drug. FAS were used to analyze all efficacy endpoints, unless otherwise stated. Following the intention-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to. | Posted | Least Squares Mean | Standard Error | liters | Week 26 |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Standardized Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12 Hours | Standardized Forced Expiratory Volume in 1 Second (FEV1) was measured with spirometry conducted according to internationally accepted standards. Measurements were made between 0 and 12 hours after treatment. FEV1 was normalized by 12 hours (divided by time). This outcome measures absolute values at week 12. Results are obtained from linear mixed model. | The Full Analysis Set (FAS) includes all randomized patients who received at least one dose of study drug. FAS were used to analyze all efficacy endpoints, unless otherwise stated. Following the intention-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to. | Posted | Least Squares Mean | Standard Error | liters | Week 12 |
|
| |||||||||||||||||||||||||||||
| Secondary | Forced Vital Capacity at All-time Points (Week 12) | Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed via spirometry. A positive change from baseline in FVC indicates improvement in lung function. This outcome measures absolute values at -45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose week 12. Results are obtained from linear mixed model. | The Full Analysis Set (FAS) includes all randomized patients who received at least one dose of study drug. FAS were used to analyze all efficacy endpoints, unless otherwise stated. Following the intention-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to. | Posted | Least Squares Mean | Standard Error | liters | -45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose on week 12 |
|
| |||||||||||||||||||||||||||||
| Secondary | Forced Vital Capacity at All-time Points (Week 26) | Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed via spirometry. A positive change from baseline in FVC indicates improvement in lung function. This outcome measures absolute values at -45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose on week 26. Results are obtained from linear mixed model. | The Full Analysis Set (FAS) includes all randomized patients who received at least one dose of study drug. FAS were used to analyze all efficacy endpoints, unless otherwise stated. Following the intention-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to. | Posted | Least Squares Mean | Standard Error | liters | -45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose on week 26 |
| ||||||||||||||||||||||||||||||
| Secondary | Focal Score of the Transitional Dyspnea Index (TDI) | Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement. | The Full Analysis Set (FAS) includes all randomized patients who received at least one dose of study drug. FAS were used to analyze all efficacy endpoints, unless otherwise stated. Following the intention-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to. | Posted | Least Squares Mean | Standard Error | units on a scale | 12 weeks and 26 weeks |
|
| |||||||||||||||||||||||||||||
| Secondary | Total Score of the St. George's Respiratory Questionnaire (SGRQ-C) | The total score of the St. George's Respiratory Questionnaire (SGRQ-C) is a health related quality of life questionnaire consisting of 51 items in three components: symptoms, activity, and impacts. The lowest possible value is zero and the highest 100. Higher values correspond to greater impairment in quality of life. | The Full Analysis Set (FAS) includes all randomized patients who received at least one dose of study drug. FAS were used to analyze all efficacy endpoints, unless otherwise stated. Following the intention-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to. | Posted | Least Squares Mean | Standard Error | units on a scale | 12 weeks and 26 weeks |
|
| |||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in Daily Number of Puffs of Rescue Medication | Participants maintained a diary to record the daily number of puffs of rescue medication used to treat COPD symptoms. | The Full Analysis Set (FAS) includes all randomized patients who received at least one dose of study drug. FAS were used to analyze all efficacy endpoints, unless otherwise stated. Following the intention-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to. | Posted | Least Squares Mean | Standard Error | puffs | Baseline, 12 weeks and 26 weeks |
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Symptom Scores Reported Using the Ediary | Participants maintained an ediary to record daily symptom scores (AM and PM) over 12 weeks and 26 weeks of treatment. This analysis compares the mean symptom scores over 12 weeks and 26 weeks compared to baseline. The diary records morning and evening daily clinical symptoms including cough, wheezing, shortness of breath, sputum volume, sputum purulence, night time awakenings and rescue medication use. Scale ranges: ranges are 0 to 3 with varying scale descriptions that pertain to the question being asked. 0 is the minimum score = "none" or "No symptoms" or "never" or "No"
| The Full Analysis Set (FAS) includes all randomized patients who received at least one dose of study drug. FAS were used to analyze all efficacy endpoints, unless otherwise stated. Following the intention-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to. | Posted | Least Squares Mean | Standard Error | units on a scale | 12 weeks and 26 weeks |
| ||||||||||||||||||||||||||||||
| Secondary | Inspiratory Capacity (IC) at All-time Points (12 Weeks) | After 12 weeks of treatment, Inspiratory Capacity (IC) was measured via spirometry, conducted according to internationally accepted standards. The mean of 3 acceptable measurements was calculated and reported in liters. | Inspiratory capacity was measured for a subset of patients QVA149 group: (78 patients (30.2%)) at baseline and 49-73 patients contributing observations at post-baseline visits. flut/salm group: (86 patients (32.6%)) at baseline and 60-79 patients contributing observations at post-baseline visits. | Posted | Least Squares Mean | Standard Error | Liters | 12 weeks |
|
| |||||||||||||||||||||||||||||
| Secondary | Inspiratory Capacity (IC) at All-time Points (26 Weeks) | After 26 weeks of treatment, Inspiratory Capacity (IC) was measured via spirometry, conducted according to internationally accepted standards. The mean of 3 acceptable measurements was calculated and reported in liters. | Inspiratory capacity was measured for a subset of patients QVA149 group: (78 patients (30.2%)) at baseline and 49-73 patients contributing observations at post-baseline visits. flut/salm group: (86 patients (32.6%)) at baseline and 60-79 patients contributing observations at post-baseline visits. | Posted | Least Squares Mean | Standard Error | Liters | 26 weeks |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events | The assessment of safety was based on Adverse Events. A summary of adverse events is presented with this outcome, additional details are provided in Adverse Events Section. | Safety set includes all participants who received at least one dose of study drug. | Posted | Number | participants | 26 weeks |
|
|
Not provided
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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 | QVA149 | Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol. | 13 | 258 | 73 | 258 | ||
| EG001 | Fluticasone/Salmeterol | Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149). | 14 | 264 | 82 | 264 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute coronary syndrome | Cardiac 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 |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Myopathy | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Oesophageal carcinoma | 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 |
| |
| Small cell lung cancer stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Carotid artery occlusion | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Epididymitis | Reproductive system and breast 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 |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Peripheral artery aneurysm | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Venous insufficiency | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Venous thrombosis limb | 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 (i.e., data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis | 41 61 324 1111 |
| 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 |
| D006024 | Glycopyrrolate |
| C554862 | indacaterol-glycopyrronium combination |
| D000068299 | Salmeterol Xinafoate |
| D000068297 | Fluticasone-Salmeterol Drug Combination |
| ID | Term |
|---|---|
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009861 | Onium Compounds |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000068298 | Fluticasone |
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
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