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

NCT02603393 | Completed Phase 4 Results

• 2 other identifiers: CQVA149A23162015-000114-22
• Study Type: interventional
• Target: 1,053
• Locations: 20 countries
• Sites: 159

Brief Summary

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

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD, QVA149

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (10)

• Annualized Rate of Moderate or Severe COPD Exacerbations

  26 weeks

• Annualized Rate of COPD Exacerbations Requiring Treatment With Systemic Glucocorticosteroids and/or Antibiotics, Moderate Exacerbations Only

  26 weeks

• Annualized Rate of COPD Exacerbations Requiring Hospitalisation

  26 weeks

• Mean Change From Baseline in Pre-dose Trough FEV1

  26 weeks

• Mean Change From Baseline in St. George's Respiratory Questionnaire

  Baseline, 12 weeks

Study Arms (2)

QVA149

EXPERIMENTAL

Drug: QVA149

Tiotropium + salmeterol/fluticasone

ACTIVE COMPARATOR

Drug: Tiotropium; Drug: Salmeterol/fluticasone

Interventions

QVA149 DRUG

QVA149 will be supplied in a capsule form in blister packs for use in the Novartis Concept 1 SDDPI

QVA149

Tiotropium DRUG

Tiotropium will be supplied as commercially available blisters, delivered via HandiHaler®

Tiotropium + salmeterol/fluticasone

Salmeterol/fluticasone DRUG

Salmeterol/fluticasone propionate dry inhalation powder delivered via Accuhaler™

Tiotropium + salmeterol/fluticasone

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have signed Informed Consent Form prior to initiation of any study-related procedure.
• 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).

You may not qualify if:

• Patients who have not achieved acceptable spirometry results at Visit 101 in accordance with ATS (American Thoracic Society)/ERS (European Respiratory Society) criteria for acceptability (one retest may be performed for patients that don't meet the acceptability 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (167)

Novartis Investigative Site

CABA, Buenos Aires, C1425BEN, Argentina

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Lanús, Buenos Aires, B8000XAV, Argentina

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Mar del Plata, Buenos Aires, 7600, Argentina

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Mar del Plata, Buenos Aires, B7600FZN, Argentina

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Novartis Investigative Site

Quilmes, Buenos Aires, B1878FNR, Argentina

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Novartis Investigative Site

Concepción del Uruguay, Entre Ríos Province, 3260, Argentina

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San Miguel de Tucumán, Tucumán Province, 4000, Argentina

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San Miguel de Tucumán, Tucumán Province, T4000IFL, Argentina

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CABA, Argentina

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Ciudad Autonoma de Bs As, C1425FVH, Argentina

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Mendoza, M5500CBA, Argentina

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Amstetten, 3300, Austria

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Feldbach, 8330, Austria

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Feldkirch, 6800, Austria

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Grieskirchen, 4710, Austria

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Thalheim bei Wels, 4600, Austria

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Antwerp, 2060, Belgium

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Erpent, 5100, Belgium

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Éghezée, 5310, Belgium

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Hasselt, 3500, Belgium

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Turnhout, 2300, Belgium

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Gabrovo, 5300, Bulgaria

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Rousse, 7000, Bulgaria

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Stara Zagora, 6000, Bulgaria

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Varna, 9000, Bulgaria

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Vancouver, British Columbia, V5Z 4E1, Canada

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Moncton, New Brunswick, E1G 1A7, Canada

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Burlington, Ontario, L7N 3V2, Canada

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Toronto, Ontario, M5T 3A9, Canada

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Toronto, Ontario, M6H 3M2, Canada

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Gatineau, Quebec, J8Y 6S8, Canada

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Québec, Quebec, G1G 3Y8, Canada

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Québec, Quebec, G1W 4R4, Canada

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Québec, Quebec, G3K 2P8, Canada

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Saint-Charles-Borromée, Quebec, J6E 2B4, Canada

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Victoriaville, Quebec, G6P 6P6, Canada

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Rijeka, HRV, 51000, Croatia

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Zagreb, 10000, Croatia

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Mělník, Czech Republic, 267 01, Czechia

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Benešov, 25601, Czechia

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Brandýs nad Labem, 25001, Czechia

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Kyjov, 697 33, Czechia

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Pilsen, 32800, Czechia

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Copenhagen NV, 2400, Denmark

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Hvidovre, 2650, Denmark

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Kohtla-Järve, 30322, Estonia

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Tallinn, 10138, Estonia

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Tallinn, 13419, Estonia

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Tartu, 51014, Estonia

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Hanover, Lower Saxony, 30159, Germany

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Peine, Lower Saxony, 31224, Germany

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Warendorf, North Rhine-Westphalia, 48231, Germany

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Koblenz, Rhineland-Palatinate, 56068, Germany

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Cottbus, Saxony, 03050, Germany

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Bad Wörishofen, 86825, Germany

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Berlin, 10117, Germany

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Berlin, 10119, Germany

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Berlin, 10367, Germany

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Berlin, 10625, Germany

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Berlin, 10717, Germany

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Berlin, 10787, Germany

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Berlin, 10969, Germany

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Berlin, 12157, Germany

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Berlin, 12159, Germany

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Berlin, 12203, Germany

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Berlin, 13156, Germany

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Bonn, 53123, Germany

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Dresden, 01069, Germany

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Erlangen, 91052, Germany

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Frankfurt, 60596, Germany

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Frankfurt am Main, 60389, Germany

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Hagen, 58089, Germany

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Hamburg, 20354, Germany

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Hamburg, 22143, Germany

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Leipzig, 04103, Germany

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Leipzig, 04109, Germany

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Leipzig, 04207, Germany

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Leipzig, 04357, Germany

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Lübeck, 23552, Germany

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Magdeburg, 39112, Germany

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Marburg, 35037, Germany

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Menden, 58706, Germany

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Neu-Isenburg, 63263, Germany

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Oschatz, 04758, Germany

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Potsdam, 14467, Germany

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Potsdam, 14469, Germany

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Rüdersdorf, 15562, Germany

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Schleswig, 24837, Germany

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Solingen, 42651, Germany

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Wiesloch, 69168, Germany

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Heraklion - Crete, Greece, 711 10, Greece

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Thessaloniki, GR, 570 10, Greece

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Athens, 106 76, Greece

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Százhalombatta, HUN, 2440, Hungary

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Törökbálint, Pest County, 2045, Hungary

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Balassagyarmat, 2660, Hungary

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Budapest, 1121, Hungary

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Szekszárd, 7100, Hungary

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Balvi, LVA, 4501, Latvia

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Jūrmala, LVA, LV-2015, Latvia

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Liepāja, LV, LV-3414, Latvia

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Riga, LV, 1011, Latvia

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Daugavpils, LV-5401, Latvia

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Krāslava, 5601, Latvia

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Riga, LV 1002, Latvia

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Riga, LV-1038, Latvia

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Kaunas, LT, LT-50128, Lithuania

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Klaipėda, LT-92231, Lithuania

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Klaipėda, LT-92288, Lithuania

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Utena, LT-28151, Lithuania

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Vilnius, 06122, Lithuania

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Vilnius, LT-08661, Lithuania

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Alkmaar, 1814HB, Netherlands

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Breda, 4819 EV, Netherlands

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Eindhoven, 5623 EJ, Netherlands

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Zutphen, 7207 AE, Netherlands

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Wroclaw, Lower Silesian Voivodeship, 53-301, Poland

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Bialystok, 15-044, Poland

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Bialystok, 15-270, Poland

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Bialystok, 15-351, Poland

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Bieńkówka, 34-212, Poland

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Krakow, 31-023, Poland

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Lodz, 90-153, Poland

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Lublin, 20-045, Poland

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Ostrów Wielkopolski, 63400, Poland

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Poznan, 60-214, Poland

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Poznan, 60-823, Poland

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Sopot, 81-741, Poland

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Tarnów, 33-100, Poland

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Wroclaw, 50-434, Poland

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Ostrowiec Swietokrzyskie, Świętokrzyskie Voivodeship, 27-400, Poland

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Bucharest, District 1, 10457, Romania

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Timișoara, Timiș County, 300310, Romania

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Arad, 310013, Romania

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Arad, 310416, Romania

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Brasov, 500086, Romania

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Bucharest, 012051, Romania

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Bucharest, 050159, Romania

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Bucharest, 303330, Romania

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Cluj-Napoca, 400371, Romania

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Deva, 330162, Romania

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Belgrade, Serbia, 11000, Serbia

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Belgrade, 11000, Serbia

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Knez-Selo, 18204, Serbia

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Kragujevac, 34000, Serbia

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Valjevo, 14000, Serbia

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Humenné, 06601, Slovakia

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Poprad, 058 01, Slovakia

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Prešov, 080 01, Slovakia

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Spišská Nová Ves, 052 01, Slovakia

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Málaga, Andalusia, 29010, Spain

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Centelles, Barcelona, 08540, Spain

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Ponferrada, Castille and León, 24400, Spain

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Canet de Mar, Catalonia, 08360, Spain

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L'Hospitalet de Llobregat, Catalonia, 08907, Spain

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Mérida, Extremadura, 06800, Spain

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Alzira, Valencia, 46600, Spain

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Sant Joan d'Alacant, Valencia, 03550, Spain

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Royal Leamington Spa, Warwickshire, CV32 4RA, United Kingdom

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Crawley, West Sussex, RH10 7DX, United Kingdom

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Bradford, West Yorkshire, BD9 6RJ, United Kingdom

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Bath, BA2 3HT, United Kingdom

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Birmingham, B15 2TH, United Kingdom

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Birmingham, B9 5SS, United Kingdom

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Coventry, CV2 2DX, United Kingdom

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Plymouth, PL5 3JB, United Kingdom

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Wolverhampton, WV10 0QP, United Kingdom

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Related Publications (1)

• 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.

  PMID: 29779416 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

indacaterol-glycopyrronium combination; Tiotropium Bromide; Fluticasone-Salmeterol Drug Combination

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Salmeterol Xinafoate; Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Amines; Phenethylamines; Ethylamines; Fluticasone; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

novartis.email@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2015
• First Posted: November 11, 2015
• Study Start: November 20, 2015
• Primary Completion: July 18, 2017
• Study Completion: July 18, 2017
• Last Updated: April 29, 2019
• Results First Posted: April 29, 2019

Record last verified: 2019-01

Locations

ES (4); GB (9); CZ (5); PL (15); RO (10); AR (11); HU (5); NL (4); DK (2); AU (5); SL (4); GR (3); CA (11); CR (2); LA (8); DE (41); SE (5); LI (6); BE (5); BU (4)