Evaluation of 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
NCT ID: NCT02603393
Last Updated: 2019-04-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
1053 participants
INTERVENTIONAL
2015-11-20
2017-07-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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QVA149
QVA149
QVA149 will be supplied in a capsule form in blister packs for use in the Novartis Concept 1 SDDPI
Tiotropium + salmeterol/fluticasone
Tiotropium
Tiotropium will be supplied as commercially available blisters, delivered via HandiHaler®
Salmeterol/fluticasone
Salmeterol/fluticasone propionate dry inhalation powder delivered via Accuhaler™
Interventions
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QVA149
QVA149 will be supplied in a capsule form in blister packs for use in the Novartis Concept 1 SDDPI
Tiotropium
Tiotropium will be supplied as commercially available blisters, delivered via HandiHaler®
Salmeterol/fluticasone
Salmeterol/fluticasone propionate dry inhalation powder delivered via Accuhaler™
Eligibility Criteria
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Inclusion Criteria
* Male and female adults aged ≥ 40 years.
* Patients with moderate to severe airflow obstruction with stable COPD (Stage 2 or Stage 3) according to the 2014 GOLD Guidelines.
* Patients with a post-bronchodilator FEV1 ≥40 and \< 80% of the predicted normal value, and post-bronchodilator FEV1/FVC \< 0.70 at run-in Visit 101. (Post refers to 15 min after inhalation of 400 µg of salbutamol).
* Current or ex-smokers who have a smoking history of at least 10 pack years (e.g. 10 pack years = 1 pack /day x 10 years, or ½ pack/day x 20 years). An ex-smoker is defined as a patient who has not smoked for ≥ 6 months at screening.
* Patients who are on triple treatment at least for the last 6 months (LAMA +LABA/ICS).
Exclusion Criteria
* Patients who have had more than one COPD exacerbation that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization in the last year prior to Visit 1.
* Patients who developed a COPD exacerbation of any severity either 6 weeks before the screening (Visit 1) or between screening (Visit 1) and treatment (Visit 201) will not be eligible but will be permitted to be re-screened after a minimum of 6 weeks after the resolution of the COPD exacerbation.
40 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
CABA, Buenos Aires, Argentina
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Lanús, Buenos Aires, Argentina
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Mar del Plata, Buenos Aires, Argentina
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Mar del Plata, Buenos Aires, Argentina
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Quilmes, Buenos Aires, Argentina
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Concepción del Uruguay, Entre Ríos Province, Argentina
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San Miguel de Tucumán, Tucumán Province, Argentina
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San Miguel de Tucumán, Tucumán Province, Argentina
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CABA, , Argentina
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Ciudad Autonoma de Bs As, , Argentina
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Mendoza, , Argentina
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Amstetten, , Austria
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Feldbach, , Austria
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Feldkirch, , Austria
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Grieskirchen, , Austria
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Thalheim bei Wels, , Austria
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Antwerp, , Belgium
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Erpent, , Belgium
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Éghezée, , Belgium
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Hasselt, , Belgium
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Turnhout, , Belgium
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Gabrovo, , Bulgaria
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Rousse, , Bulgaria
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Stara Zagora, , Bulgaria
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Varna, , Bulgaria
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Vancouver, British Columbia, Canada
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Moncton, New Brunswick, Canada
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Burlington, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Gatineau, Quebec, Canada
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Québec, Quebec, Canada
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Québec, Quebec, Canada
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Québec, Quebec, Canada
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Saint-Charles-Borromée, Quebec, Canada
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Victoriaville, Quebec, Canada
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Rijeka, HRV, Croatia
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Zagreb, , Croatia
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Mělník, Czech Republic, Czechia
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Benešov, , Czechia
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Brandýs nad Labem, , Czechia
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Kyjov, , Czechia
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Pilsen, , Czechia
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Copenhagen NV, , Denmark
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Hvidovre, , Denmark
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Kohtla-Järve, , Estonia
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Tallinn, , Estonia
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Tallinn, , Estonia
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Tartu, , Estonia
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Hanover, Lower Saxony, Germany
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Peine, Lower Saxony, Germany
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Warendorf, North Rhine-Westphalia, Germany
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Koblenz, Rhineland-Palatinate, Germany
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Cottbus, Saxony, Germany
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Bad Wörishofen, , Germany
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Berlin, , Germany
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Bonn, , Germany
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Dresden, , Germany
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Erlangen, , Germany
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Frankfurt, , Germany
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Frankfurt am Main, , Germany
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Hagen, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Leipzig, , Germany
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Leipzig, , Germany
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Leipzig, , Germany
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Lübeck, , Germany
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Magdeburg, , Germany
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Marburg, , Germany
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Menden, , Germany
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Neu-Isenburg, , Germany
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Oschatz, , Germany
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Potsdam, , Germany
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Potsdam, , Germany
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Rudersdorf, , Germany
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Schleswig, , Germany
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Solingen, , Germany
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Wiesloch, , Germany
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Heraklion - Crete, Greece, Greece
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Thessaloniki, GR, Greece
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Athens, , Greece
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Százhalombatta, HUN, Hungary
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Törökbálint, Pest County, Hungary
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Balassagyarmat, , Hungary
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Budapest, , Hungary
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Szekszárd, , Hungary
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Balvi, LVA, Latvia
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Jūrmala, LVA, Latvia
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Liepāja, LV, Latvia
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Riga, LV, Latvia
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Daugavpils, , Latvia
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Krāslava, , Latvia
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Riga, , Latvia
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Riga, , Latvia
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Kaunas, LT, Lithuania
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Klaipėda, , Lithuania
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Klaipėda, , Lithuania
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Utena, , Lithuania
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Vilnius, , Lithuania
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Vilnius, , Lithuania
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Alkmaar, , Netherlands
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Breda, , Netherlands
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Eindhoven, , Netherlands
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Zutphen, , Netherlands
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Wroclaw, Lower Silesian Voivodeship, Poland
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Bialystok, , Poland
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Bialystok, , Poland
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Bialystok, , Poland
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Bieńkówka, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Lublin, , Poland
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Ostrów Wielkopolski, , Poland
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Poznan, , Poland
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Poznan, , Poland
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Sopot, , Poland
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Tarnów, , Poland
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Wroclaw, , Poland
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Ostrowiec Swietokrzyskie, Świętokrzyskie Voivodeship, Poland
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Bucharest, District 1, Romania
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Timișoara, Timiș County, Romania
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Arad, , Romania
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Arad, , Romania
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Brasov, , Romania
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Bucharest, , Romania
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Cluj-Napoca, , Romania
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Deva, , Romania
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Belgrade, Serbia, Serbia
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Belgrade, , Serbia
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Knez-Selo, , Serbia
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Kragujevac, , Serbia
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Valjevo, , Serbia
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Humenné, , Slovakia
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Poprad, , Slovakia
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Prešov, , Slovakia
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Spišská Nová Ves, , Slovakia
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Málaga, Andalusia, Spain
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Centelles, Barcelona, Spain
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Ponferrada, Castille and León, Spain
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Canet de Mar, Catalonia, Spain
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L'Hospitalet de Llobregat, Catalonia, Spain
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Mérida, Extremadura, Spain
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Alzira, Valencia, Spain
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Sant Joan d'Alacant, Valencia, Spain
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Royal Leamington Spa, Warwickshire, United Kingdom
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Crawley, West Sussex, United Kingdom
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Bradford, West Yorkshire, United Kingdom
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Bath, , United Kingdom
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Birmingham, , United Kingdom
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Birmingham, , United Kingdom
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Coventry, , United Kingdom
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Plymouth, , United Kingdom
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Wolverhampton, , United Kingdom
Countries
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References
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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.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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2015-000114-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CQVA149A2316
Identifier Type: -
Identifier Source: org_study_id
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