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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-000114-22 | EudraCT Number |
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This study will evaluate the efficacy and safety of QVA149 (110/50 μg o.d.) vs tiotropium (18 µg o.d.) + salmeterol/fluticasone propionate FDC (50/500 µg b.i.d.) in patients with moderate to severe COPD
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QVA149 | Experimental |
| |
| Tiotropium + salmeterol/fluticasone | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QVA149 | Drug | QVA149 will be supplied in a capsule form in blister packs for use in the Novartis Concept 1 SDDPI |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Post-dose Trough FEV1 | Mean change from baseline in post-dose trough forced expiratory volume in 1 second (FEV1) following 26 weeks of treatment. Trough FEV1 is defined as the mean of the two FEV1 values measured at 23 hr 15 min and 23 hr 45 min after the morning dose taken at site on Day 181. Baseline FEV1 is defined as the average of the pre-dose FEV1 measured at -45 min and -15 min at Day 1. | Baseline, 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Annualized Rate of Moderate or Severe COPD Exacerbations | Moderate or severe COPD exacerbations starting between first dose and one day after last treatment are included. COPD exacerbations that occurred within 7 days of each other are collapsed as one event. | 26 weeks |
| Annualized Rate of COPD Exacerbations Requiring Treatment With Systemic Glucocorticosteroids and/or Antibiotics, Moderate Exacerbations Only |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | CABA | Buenos Aires | C1425BEN | Argentina | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29779416 | Derived | Chapman KR, Hurst JR, Frent SM, Larbig M, Fogel R, Guerin T, Banerji D, Patalano F, Goyal P, Pfister P, Kostikas K, Wedzicha JA. Long-Term Triple Therapy De-escalation to Indacaterol/Glycopyrronium in Patients with Chronic Obstructive Pulmonary Disease (SUNSET): A Randomized, Double-Blind, Triple-Dummy Clinical Trial. Am J Respir Crit Care Med. 2018 Aug 1;198(3):329-339. doi: 10.1164/rccm.201803-0405OC. |
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| ID | Title | Description |
|---|---|---|
| FG000 | QVA149 | 110/50 μg capsules o.d. for inhalation |
| FG001 | Tiotropium + Salmeterol/Fluticasone | tiotropium (18 μg o.d.), and salmeterol/fluticasone propionate FDC (50/500 μg b.i.d.) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 18, 2017 | Jul 9, 2018 |
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| Tiotropium | Drug | Tiotropium will be supplied as commercially available blisters, delivered via HandiHaler® |
|
| Salmeterol/fluticasone | Drug | Salmeterol/fluticasone propionate dry inhalation powder delivered via Accuhaler™ |
|
COPD exacerbations starting between first dose and one day after last treatment are included. COPD exacerbations that occurred within 7 days of each other are collapsed as one event |
| 26 weeks |
| Annualized Rate of COPD Exacerbations Requiring Hospitalisation | COPD exacerbations starting between first dose and one day after last treatment are included. COPD exacerbations that occurred within 7 days of each other are collapsed as one event. | 26 weeks |
| Mean Change From Baseline in Pre-dose Trough FEV1 | Trough FEV1 is defined as the average of the pre-dose FEV1 measurements at -45 min and -15 min prior to dosing at each visit except Day 182 which is the average of the post-dose FEV1 measurements at 23h15min and 23h45min after dosing at Day 181. Baseline FEV1 is considered the Day 1 average of pre-dose measurements. | 26 weeks |
| Mean Change From Baseline in St. George's Respiratory Questionnaire | The St. George Respiratory Questionnaire C (SGRQ-C) is used to provide the health status measurements in this study. Baseline SGRQ-C is defined as the assessment taken right before the first dose of the double-blind drug on Day 1. Higher values correspond to greater impairment of health status. The SGRQ contains 50 items divided into 2 parts covering 3 aspects of health related to COPD: Part I covers "Symptoms" and is concerned with respiratory symptoms, their frequency and severity; Part II covers "Activity" and is concerned with activities that cause or are limited by breathlessness; Part II is also concerned with "Impacts", which covers a range of aspects concerned with social functioning and psychological disturbances resulting from airways disease. A score was calculated for each of these 3 subscales and a "Total" score was calculated. In each case the lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status. | Baseline, 12 weeks |
| Mean Change From Baseline in St. George's Respiratory Questionnaire | The St. George Respiratory Questionnaire C (SGRQ-C) is used to provide the health status measurements in this study. Baseline SGRQ-C is defined as the assessment taken right before the first dose of the double-blind drug on Day 1. Higher values correspond to greater impairment of health status. The SGRQ contains 50 items divided into 2 parts covering 3 aspects of health related to COPD: Part I covers "Symptoms" and is concerned with respiratory symptoms, their frequency and severity; Part II covers "Activity" and is concerned with activities that cause or are limited by breathlessness; Part II is also concerned with "Impacts", which covers a range of aspects concerned with social functioning and psychological disturbances resulting from airways disease. A score was calculated for each of these 3 subscales and a "Total" score was calculated. In each case the lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status. | Baseline, 26 weeks |
| Transition Dyspnea Index (TDI) Score | Transitional Dyspnea Index (TDI) score presents the degree of impairment due to dyspnea. The lower the score the worse the severity of dyspnea. The Baseline Dyspnea Index (BDI) / TDI is an instrument used to assess a participant's level of dyspnea. The BDI and TDI each have three domains: functional impairment, magnitude of task and magnitude of effort. BDI domains were rated from 0 (severe) to 4 (unimpaired) and rates summed for baseline focal score ranged from 0 to 12; lower scores mean worse severity. TDI domains were rated from -3 (major deterioration) to 3 (major improvement) and rates summed for transition focal score ranged from -9 to 9; negative scores indicate deterioration. A TDI focal score of ≥1 was defined as a clinically important improvement from baseline. | 12 weeks |
| Transition Dyspnea Index (TDI) Score | Transitional Dyspnea Index (TDI) score presents the degree of impairment due to dyspnea. The lower the score the worse the severity of dyspnea. The Baseline Dyspnea Index (BDI) / TDI is an instrument used to assess a participant's level of dyspnea. The BDI and TDI each have three domains: functional impairment, magnitude of task and magnitude of effort. BDI domains were rated from 0 (severe) to 4 (unimpaired) and rates summed for baseline focal score ranged from 0 to 12; lower scores mean worse severity. TDI domains were rated from -3 (major deterioration) to 3 (major improvement) and rates summed for transition focal score ranged from -9 to 9; negative scores indicate deterioration. A TDI focal score of ≥1 was defined as a clinically important improvement from baseline. | 26 weeks |
| Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication | Change from baseline in mean daily number of puffs of rescue medication (number of puffs taken in the previous 12 hours) over 26 weeks of treatment. | Baseline, 26 weeks |
| Mean Change From Baseline in Forced Vital Capacity (FVC) | Change from baseline in forced vital capacity following 26 weeks of treatment. Trough FVC is defined as the average of the pre-dose FVC measurements at -45 min and -15 min prior to dosing at each visit except Day 182 which is the average of the post-dose FVC measurements at 23h15min and 23h45min after dosing at Day 181. Baseline is considered the Day 1 average of pre-dose measurements. | Baseline, 26 weeks |
| Lanus |
| Buenos Aires |
| B8000XAV |
| Argentina |
| Novartis Investigative Site | Mar del Plata | Buenos Aires | 7600 | Argentina |
| Novartis Investigative Site | Mar del Plata | Buenos Aires | B7600FZN | Argentina |
| Novartis Investigative Site | Quilmes | Buenos Aires | B1878FNR | Argentina |
| Novartis Investigative Site | Concepción del Uruguay | Entre Ríos Province | 3260 | 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 | CABA | Argentina |
| Novartis Investigative Site | Ciudad Autonoma de Bs As | C1425FVH | Argentina |
| Novartis Investigative Site | Mendoza | M5500CBA | Argentina |
| Novartis Investigative Site | Amstetten | 3300 | Austria |
| Novartis Investigative Site | Feldbach | 8330 | Austria |
| Novartis Investigative Site | Feldkirch | 6800 | Austria |
| Novartis Investigative Site | Grieskirchen | 4710 | Austria |
| Novartis Investigative Site | Thalheim bei Wels | 4600 | Austria |
| Novartis Investigative Site | Antwerp | 2060 | Belgium |
| Novartis Investigative Site | Erpent | 5100 | Belgium |
| Novartis Investigative Site | Éghezée | 5310 | Belgium |
| Novartis Investigative Site | Hasselt | 3500 | Belgium |
| Novartis Investigative Site | Turnhout | 2300 | Belgium |
| Novartis Investigative Site | Gabrovo | 5300 | Bulgaria |
| Novartis Investigative Site | Rousse | 7000 | Bulgaria |
| Novartis Investigative Site | Stara Zagora | 6000 | Bulgaria |
| Novartis Investigative Site | Varna | 9000 | Bulgaria |
| Novartis Investigative Site | Vancouver | British Columbia | V5Z 4E1 | Canada |
| Novartis Investigative Site | Moncton | New Brunswick | E1G 1A7 | Canada |
| Novartis Investigative Site | Burlington | Ontario | L7N 3V2 | Canada |
| Novartis Investigative Site | Toronto | Ontario | M5T 3A9 | Canada |
| Novartis Investigative Site | Toronto | Ontario | M6H 3M2 | Canada |
| Novartis Investigative Site | Gatineau | Quebec | J8Y 6S8 | Canada |
| Novartis Investigative Site | Québec | Quebec | G1G 3Y8 | Canada |
| Novartis Investigative Site | Québec | Quebec | G1W 4R4 | Canada |
| Novartis Investigative Site | Québec | Quebec | G3K 2P8 | Canada |
| Novartis Investigative Site | Saint-Charles-Borromée | Quebec | J6E 2B4 | Canada |
| Novartis Investigative Site | Victoriaville | Quebec | G6P 6P6 | Canada |
| Novartis Investigative Site | Rijeka | HRV | 51000 | Croatia |
| Novartis Investigative Site | Zagreb | 10000 | Croatia |
| Novartis Investigative Site | Mělník | Czech Republic | 267 01 | Czechia |
| Novartis Investigative Site | Benešov | 25601 | Czechia |
| Novartis Investigative Site | Brandýs nad Labem | 25001 | Czechia |
| Novartis Investigative Site | Kyjov | 697 33 | Czechia |
| Novartis Investigative Site | Pilsen | 32800 | Czechia |
| Novartis Investigative Site | Copenhagen NV | 2400 | Denmark |
| Novartis Investigative Site | Hvidovre | 2650 | Denmark |
| Novartis Investigative Site | Kohtla-Järve | 30322 | Estonia |
| Novartis Investigative Site | Tallinn | 10138 | Estonia |
| Novartis Investigative Site | Tallinn | 13419 | Estonia |
| Novartis Investigative Site | Tartu | 51014 | Estonia |
| Novartis Investigative Site | Hanover | Lower Saxony | 30159 | Germany |
| Novartis Investigative Site | Peine | Lower Saxony | 31224 | Germany |
| Novartis Investigative Site | Warendorf | North Rhine-Westphalia | 48231 | Germany |
| Novartis Investigative Site | Koblenz | Rhineland-Palatinate | 56068 | Germany |
| Novartis Investigative Site | Cottbus | Saxony | 03050 | Germany |
| Novartis Investigative Site | Bad Wörishofen | 86825 | Germany |
| Novartis Investigative Site | Berlin | 10117 | Germany |
| Novartis Investigative Site | Berlin | 10119 | Germany |
| Novartis Investigative Site | Berlin | 10367 | Germany |
| Novartis Investigative Site | Berlin | 10625 | Germany |
| Novartis Investigative Site | Berlin | 10717 | Germany |
| Novartis Investigative Site | Berlin | 10787 | Germany |
| Novartis Investigative Site | Berlin | 10969 | Germany |
| Novartis Investigative Site | Berlin | 12157 | Germany |
| Novartis Investigative Site | Berlin | 12159 | Germany |
| Novartis Investigative Site | Berlin | 12203 | Germany |
| Novartis Investigative Site | Berlin | 13156 | Germany |
| Novartis Investigative Site | Bonn | 53123 | Germany |
| Novartis Investigative Site | Dresden | 01069 | Germany |
| Novartis Investigative Site | Erlangen | 91052 | Germany |
| Novartis Investigative Site | Frankfurt | 60596 | Germany |
| Novartis Investigative Site | Frankfurt am Main | 60389 | Germany |
| Novartis Investigative Site | Hagen | 58089 | Germany |
| Novartis Investigative Site | Hamburg | 20354 | Germany |
| Novartis Investigative Site | Hamburg | 22143 | Germany |
| Novartis Investigative Site | Leipzig | 04103 | Germany |
| Novartis Investigative Site | Leipzig | 04109 | Germany |
| Novartis Investigative Site | Leipzig | 04207 | Germany |
| Novartis Investigative Site | Leipzig | 04357 | Germany |
| Novartis Investigative Site | Lübeck | 23552 | Germany |
| Novartis Investigative Site | Magdeburg | 39112 | Germany |
| Novartis Investigative Site | Marburg | 35037 | Germany |
| Novartis Investigative Site | Menden | 58706 | Germany |
| Novartis Investigative Site | Neu-Isenburg | 63263 | Germany |
| Novartis Investigative Site | Oschatz | 04758 | Germany |
| Novartis Investigative Site | Potsdam | 14467 | Germany |
| Novartis Investigative Site | Potsdam | 14469 | Germany |
| Novartis Investigative Site | Rüdersdorf | 15562 | Germany |
| Novartis Investigative Site | Schleswig | 24837 | Germany |
| Novartis Investigative Site | Solingen | 42651 | Germany |
| Novartis Investigative Site | Wiesloch | 69168 | Germany |
| Novartis Investigative Site | Heraklion - Crete | Greece | 711 10 | Greece |
| Novartis Investigative Site | Thessaloniki | GR | 570 10 | Greece |
| Novartis Investigative Site | Athens | 106 76 | Greece |
| Novartis Investigative Site | Százhalombatta | HUN | 2440 | Hungary |
| Novartis Investigative Site | Törökbálint | Pest County | 2045 | Hungary |
| Novartis Investigative Site | Balassagyarmat | 2660 | Hungary |
| Novartis Investigative Site | Budapest | 1121 | Hungary |
| Novartis Investigative Site | Szekszárd | 7100 | Hungary |
| Novartis Investigative Site | Balvi | LVA | 4501 | Latvia |
| Novartis Investigative Site | Jūrmala | LVA | LV-2015 | Latvia |
| Novartis Investigative Site | Liepāja | LV | LV-3414 | Latvia |
| Novartis Investigative Site | Riga | LV | 1011 | Latvia |
| Novartis Investigative Site | Daugavpils | LV-5401 | Latvia |
| Novartis Investigative Site | Krāslava | 5601 | Latvia |
| Novartis Investigative Site | Riga | LV 1002 | Latvia |
| Novartis Investigative Site | Riga | LV-1038 | Latvia |
| Novartis Investigative Site | Kaunas | LT | LT-50128 | Lithuania |
| Novartis Investigative Site | Klaipėda | LT-92231 | Lithuania |
| Novartis Investigative Site | Klaipėda | LT-92288 | Lithuania |
| Novartis Investigative Site | Utena | LT-28151 | Lithuania |
| Novartis Investigative Site | Vilnius | 06122 | Lithuania |
| Novartis Investigative Site | Vilnius | LT-08661 | Lithuania |
| Novartis Investigative Site | Alkmaar | 1814HB | Netherlands |
| Novartis Investigative Site | Breda | 4819 EV | Netherlands |
| Novartis Investigative Site | Eindhoven | 5623 EJ | Netherlands |
| Novartis Investigative Site | Zutphen | 7207 AE | Netherlands |
| Novartis Investigative Site | Wroclaw | Lower Silesian Voivodeship | 53-301 | Poland |
| Novartis Investigative Site | Bialystok | 15-044 | Poland |
| Novartis Investigative Site | Bialystok | 15-270 | Poland |
| Novartis Investigative Site | Bialystok | 15-351 | Poland |
| Novartis Investigative Site | Bieńkówka | 34-212 | Poland |
| Novartis Investigative Site | Krakow | 31-023 | Poland |
| Novartis Investigative Site | Lodz | 90-153 | Poland |
| Novartis Investigative Site | Lublin | 20-045 | Poland |
| Novartis Investigative Site | Ostrów Wielkopolski | 63400 | Poland |
| Novartis Investigative Site | Poznan | 60-214 | Poland |
| Novartis Investigative Site | Poznan | 60-823 | Poland |
| Novartis Investigative Site | Sopot | 81-741 | Poland |
| Novartis Investigative Site | Tarnów | 33-100 | Poland |
| Novartis Investigative Site | Wroclaw | 50-434 | Poland |
| Novartis Investigative Site | Ostrowiec Swietokrzyskie | Świętokrzyskie Voivodeship | 27-400 | Poland |
| Novartis Investigative Site | Bucharest | District 1 | 10457 | Romania |
| Novartis Investigative Site | Timișoara | Timiș County | 300310 | Romania |
| Novartis Investigative Site | Arad | 310013 | Romania |
| Novartis Investigative Site | Arad | 310416 | Romania |
| Novartis Investigative Site | Brasov | 500086 | Romania |
| Novartis Investigative Site | Bucharest | 012051 | Romania |
| Novartis Investigative Site | Bucharest | 050159 | Romania |
| Novartis Investigative Site | Bucharest | 303330 | Romania |
| Novartis Investigative Site | Cluj-Napoca | 400371 | Romania |
| Novartis Investigative Site | Deva | 330162 | Romania |
| Novartis Investigative Site | Belgrade | Serbia | 11000 | Serbia |
| Novartis Investigative Site | Belgrade | 11000 | Serbia |
| Novartis Investigative Site | Knez-Selo | 18204 | Serbia |
| Novartis Investigative Site | Kragujevac | 34000 | Serbia |
| Novartis Investigative Site | Valjevo | 14000 | Serbia |
| Novartis Investigative Site | Humenné | 06601 | Slovakia |
| Novartis Investigative Site | Poprad | 058 01 | Slovakia |
| Novartis Investigative Site | Prešov | 080 01 | Slovakia |
| Novartis Investigative Site | Spišská Nová Ves | 052 01 | Slovakia |
| Novartis Investigative Site | Málaga | Andalusia | 29010 | Spain |
| Novartis Investigative Site | Centelles | Barcelona | 08540 | Spain |
| Novartis Investigative Site | Ponferrada | Castille and León | 24400 | Spain |
| Novartis Investigative Site | Canet de Mar | Catalonia | 08360 | Spain |
| Novartis Investigative Site | L'Hospitalet de Llobregat | Catalonia | 08907 | Spain |
| Novartis Investigative Site | Mérida | Extremadura | 06800 | Spain |
| Novartis Investigative Site | Alzira | Valencia | 46600 | Spain |
| Novartis Investigative Site | Sant Joan d'Alacant | Valencia | 03550 | Spain |
| Novartis Investigative Site | Royal Leamington Spa | Warwickshire | CV32 4RA | United Kingdom |
| Novartis Investigative Site | Crawley | West Sussex | RH10 7DX | United Kingdom |
| Novartis Investigative Site | Bradford | West Yorkshire | BD9 6RJ | United Kingdom |
| Novartis Investigative Site | Bath | BA2 3HT | United Kingdom |
| Novartis Investigative Site | Birmingham | B15 2TH | United Kingdom |
| Novartis Investigative Site | Birmingham | B9 5SS | United Kingdom |
| Novartis Investigative Site | Coventry | CV2 2DX | United Kingdom |
| Novartis Investigative Site | Plymouth | PL5 3JB | United Kingdom |
| Novartis Investigative Site | Wolverhampton | WV10 0QP | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | QVA149 | 110/50 μg capsules o.d. for inhalation |
| BG001 | Tiotropium + Salmeterol/Fluticasone | tiotropium (18 μg o.d.), and salmeterol/fluticasone propionate FDC (50/500 μg 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 |
| ||||||||||||||||
| Race (NIH/OMB) | 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 | Mean Change From Baseline in Post-dose Trough FEV1 | Mean change from baseline in post-dose trough forced expiratory volume in 1 second (FEV1) following 26 weeks of treatment. Trough FEV1 is defined as the mean of the two FEV1 values measured at 23 hr 15 min and 23 hr 45 min after the morning dose taken at site on Day 181. Baseline FEV1 is defined as the average of the pre-dose FEV1 measured at -45 min and -15 min at Day 1. | Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study drug. Patients in the FAS were analyzed according to the treatment they were randomized to. | Posted | Least Squares Mean | Standard Error | Liters | Baseline, 26 weeks |
|
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| Secondary | Annualized Rate of Moderate or Severe COPD Exacerbations | Moderate or severe COPD exacerbations starting between first dose and one day after last treatment are included. COPD exacerbations that occurred within 7 days of each other are collapsed as one event. | Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study drug. Patients in the FAS were analyzed according to the treatment they were randomized to. | Posted | Number | 95% Confidence Interval | COPD exacerbations/year | 26 weeks |
|
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| Secondary | Annualized Rate of COPD Exacerbations Requiring Treatment With Systemic Glucocorticosteroids and/or Antibiotics, Moderate Exacerbations Only | COPD exacerbations starting between first dose and one day after last treatment are included. COPD exacerbations that occurred within 7 days of each other are collapsed as one event | Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study drug. Patients in the FAS were analyzed according to the treatment they were randomized to. | Posted | Number | 95% Confidence Interval | COPD Exacerbations/year | 26 weeks |
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| Secondary | Annualized Rate of COPD Exacerbations Requiring Hospitalisation | COPD exacerbations starting between first dose and one day after last treatment are included. COPD exacerbations that occurred within 7 days of each other are collapsed as one event. | Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study drug. Patients in the FAS were analyzed according to the treatment they were randomized to. | Posted | Number | 95% Confidence Interval | COPD Exacerbations/year | 26 weeks |
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| Secondary | Mean Change From Baseline in Pre-dose Trough FEV1 | Trough FEV1 is defined as the average of the pre-dose FEV1 measurements at -45 min and -15 min prior to dosing at each visit except Day 182 which is the average of the post-dose FEV1 measurements at 23h15min and 23h45min after dosing at Day 181. Baseline FEV1 is considered the Day 1 average of pre-dose measurements. | Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study drug. Patients in the FAS were analyzed according to the treatment they were randomized to. | Posted | Least Squares Mean | Standard Error | Liters | 26 weeks |
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| Secondary | Mean Change From Baseline in St. George's Respiratory Questionnaire | The St. George Respiratory Questionnaire C (SGRQ-C) is used to provide the health status measurements in this study. Baseline SGRQ-C is defined as the assessment taken right before the first dose of the double-blind drug on Day 1. Higher values correspond to greater impairment of health status. The SGRQ contains 50 items divided into 2 parts covering 3 aspects of health related to COPD: Part I covers "Symptoms" and is concerned with respiratory symptoms, their frequency and severity; Part II covers "Activity" and is concerned with activities that cause or are limited by breathlessness; Part II is also concerned with "Impacts", which covers a range of aspects concerned with social functioning and psychological disturbances resulting from airways disease. A score was calculated for each of these 3 subscales and a "Total" score was calculated. In each case the lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status. | Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study drug. Patients in the FAS were analyzed according to the treatment they were randomized to. | Posted | Least Squares Mean | Standard Error | Score on a scale | Baseline, 12 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in St. George's Respiratory Questionnaire | The St. George Respiratory Questionnaire C (SGRQ-C) is used to provide the health status measurements in this study. Baseline SGRQ-C is defined as the assessment taken right before the first dose of the double-blind drug on Day 1. Higher values correspond to greater impairment of health status. The SGRQ contains 50 items divided into 2 parts covering 3 aspects of health related to COPD: Part I covers "Symptoms" and is concerned with respiratory symptoms, their frequency and severity; Part II covers "Activity" and is concerned with activities that cause or are limited by breathlessness; Part II is also concerned with "Impacts", which covers a range of aspects concerned with social functioning and psychological disturbances resulting from airways disease. A score was calculated for each of these 3 subscales and a "Total" score was calculated. In each case the lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status. | Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study drug. patients in the FAS were analyzed according to the treatment they were randomized to. | Posted | Least Squares Mean | Standard Error | Score on a scale | Baseline, 26 weeks |
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| Secondary | Transition Dyspnea Index (TDI) Score | Transitional Dyspnea Index (TDI) score presents the degree of impairment due to dyspnea. The lower the score the worse the severity of dyspnea. The Baseline Dyspnea Index (BDI) / TDI is an instrument used to assess a participant's level of dyspnea. The BDI and TDI each have three domains: functional impairment, magnitude of task and magnitude of effort. BDI domains were rated from 0 (severe) to 4 (unimpaired) and rates summed for baseline focal score ranged from 0 to 12; lower scores mean worse severity. TDI domains were rated from -3 (major deterioration) to 3 (major improvement) and rates summed for transition focal score ranged from -9 to 9; negative scores indicate deterioration. A TDI focal score of ≥1 was defined as a clinically important improvement from baseline. | Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study drug. Patients in the FAS were analyzed according to the treatment they were randomized to. | Posted | Least Squares Mean | Standard Error | Score on a scale | 12 weeks |
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| Secondary | Transition Dyspnea Index (TDI) Score | Transitional Dyspnea Index (TDI) score presents the degree of impairment due to dyspnea. The lower the score the worse the severity of dyspnea. The Baseline Dyspnea Index (BDI) / TDI is an instrument used to assess a participant's level of dyspnea. The BDI and TDI each have three domains: functional impairment, magnitude of task and magnitude of effort. BDI domains were rated from 0 (severe) to 4 (unimpaired) and rates summed for baseline focal score ranged from 0 to 12; lower scores mean worse severity. TDI domains were rated from -3 (major deterioration) to 3 (major improvement) and rates summed for transition focal score ranged from -9 to 9; negative scores indicate deterioration. A TDI focal score of ≥1 was defined as a clinically important improvement from baseline. | Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study drug. Patients in the FAS were analyzed according to the treatment they were randomized to. | Posted | Least Squares Mean | Standard Error | Score on a scale | 26 weeks |
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| Secondary | Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication | Change from baseline in mean daily number of puffs of rescue medication (number of puffs taken in the previous 12 hours) over 26 weeks of treatment. | Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study drug. Patients in the FAS were analyzed according to the treatment they were randomized to. | Posted | Least Squares Mean | Standard Error | Number of puffs per day | Baseline, 26 weeks |
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| Secondary | Mean Change From Baseline in Forced Vital Capacity (FVC) | Change from baseline in forced vital capacity following 26 weeks of treatment. Trough FVC is defined as the average of the pre-dose FVC measurements at -45 min and -15 min prior to dosing at each visit except Day 182 which is the average of the post-dose FVC measurements at 23h15min and 23h45min after dosing at Day 181. Baseline is considered the Day 1 average of pre-dose measurements. | Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study drug. Patients in the FAS were analyzed according to the treatment they were randomized to. | Posted | Least Squares Mean | Standard Error | Liters | Baseline, 26 weeks |
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The study consists of four epochs: screening (1 week), run-in (4 weeks), blinded treatment (26 weeks) and follow-up (4 weeks).
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 | QVA149 | 110/50 μg capsules o.d. for inhalation | 4 | 527 | 32 | 527 | 398 | 527 |
| EG001 | Tio+Salm/Flut | tiotropium (18 μg o.d.), and salmeterol/fluticasone propionate FDC (50/500 μg b.i.d.) | 5 | 526 | 34 | 526 | 392 | 526 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haemorrhagic anaemia | Blood and lymphatic system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Inappropriate antidiuretic hormone secretion | Endocrine disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Anal fissure | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Ophthalmic herpes zoster | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| Multiple injuries | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
| |
| Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Bladder neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Systematic Assessment |
| |
| Cholesteatoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Systematic Assessment |
| |
| Colon neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Systematic Assessment |
| |
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Systematic Assessment |
| |
| Pituitary tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Systematic Assessment |
| |
| Renal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Aortic aneurysm rupture | Vascular disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Aortic dissection | Vascular disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Peripheral artery occlusion | Vascular disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Peripheral artery stenosis | Vascular disorders | MedDRA (20.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrioventricular block first degree | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Oropharyngeal candidiasis | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Upper respiratory tract infection bacterial | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (20.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (20.0) | 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 or disclosure of trial results in their entirety
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | novartis.email@novartis.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Aug 9, 2017 | Jul 9, 2018 | Prot_001.pdf |
| 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 |
|---|---|
| C554862 | indacaterol-glycopyrronium combination |
| D000069447 | Tiotropium Bromide |
| D000068297 | Fluticasone-Salmeterol Drug Combination |
| ID | Term |
|---|---|
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D000068299 | Salmeterol Xinafoate |
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D000588 | Amines |
| 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 |
Not provided
Not provided
| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
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tiotropium (18 μg o.d.), and salmeterol/fluticasone propionate FDC (50/500 μg b.i.d.)
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tiotropium (18 μg o.d.), and salmeterol/fluticasone propionate FDC (50/500 μg b.i.d.)
|
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| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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