Clinical trial NCT02603393: 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
Official title: A 26-week, Randomized, Double Blind, Parallel-group Multicenter Study to Assess 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD, QVA149
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2015-11-11
Enrollment: 1053
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Mean Change From Baseline in Post-dose Trough FEV1
timeFrame: Baseline, 26 weeks
Secondary outcomes:
measure: Annualized Rate of Moderate or Severe COPD Exacerbations
timeFrame: 26 weeks
measure: Annualized Rate of COPD Exacerbations Requiring Treatment With Systemic Glucocorticosteroids and/or Antibiotics, Moderate Exacerbations Only
timeFrame: 26 weeks
measure: Annualized Rate of COPD Exacerbations Requiring Hospitalisation
timeFrame: 26 weeks
measure: Mean Change From Baseline in Pre-dose Trough FEV1
timeFrame: 26 weeks
measure: Mean Change From Baseline in St. George's Respiratory Questionnaire
timeFrame: Baseline, 12 weeks
measure: Mean Change From Baseline in St. George's Respiratory Questionnaire
timeFrame: Baseline, 26 weeks
measure: Transition Dyspnea Index (TDI) Score
timeFrame: 12 weeks
measure: Transition Dyspnea Index (TDI) Score
timeFrame: 26 weeks
measure: Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication
timeFrame: Baseline, 26 weeks
measure: Mean Change From Baseline in Forced Vital Capacity (FVC)
timeFrame: Baseline, 26 weeks
Other outcomes:
Locations:
city: Caba
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Lanus
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Mar del Plata
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Mar del Plata
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Quilmes
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Concepcion del Uruguay
country: Argentina
facility: Novartis Investigative Site
state: Entre Rios
city: San Miguel de Tucuman
country: Argentina
facility: Novartis Investigative Site
state: Tucuman
city: San Miguel de Tucuman
country: Argentina
facility: Novartis Investigative Site
state: Tucuman
city: Caba
country: Argentina
facility: Novartis Investigative Site
city: Ciudad Autonoma de Bs As
country: Argentina
facility: Novartis Investigative Site
city: Mendoza
country: Argentina
facility: Novartis Investigative Site
city: Amstetten
country: Austria
facility: Novartis Investigative Site
city: Feldbach
country: Austria
facility: Novartis Investigative Site
city: Feldkirch
country: Austria
facility: Novartis Investigative Site
city: Grieskirchen
country: Austria
facility: Novartis Investigative Site
city: Thalheim bei Wels
country: Austria
facility: Novartis Investigative Site
city: Antwerpen
country: Belgium
facility: Novartis Investigative Site
city: Eghezee
country: Belgium
facility: Novartis Investigative Site
city: Erpent
country: Belgium
facility: Novartis Investigative Site
city: Hasselt
country: Belgium
facility: Novartis Investigative Site
city: Turnhout
country: Belgium
facility: Novartis Investigative Site
city: Gabrovo
country: Bulgaria
facility: Novartis Investigative Site
city: Ruse
country: Bulgaria
facility: Novartis Investigative Site
city: Stara Zagora
country: Bulgaria
facility: Novartis Investigative Site
city: Varna
country: Bulgaria
facility: Novartis Investigative Site
city: Vancouver
country: Canada
facility: Novartis Investigative Site
state: British Columbia
city: Moncton
country: Canada
facility: Novartis Investigative Site
state: New Brunswick
city: Burlington
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Gatineau
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: St-Charles-Borromée
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Victoriaville
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Quebec
country: Canada
facility: Novartis Investigative Site
city: Quebec
country: Canada
facility: Novartis Investigative Site
city: Quebec
country: Canada
facility: Novartis Investigative Site
city: Rijeka
country: Croatia
facility: Novartis Investigative Site
state: HRV
city: Zagreb
country: Croatia
facility: Novartis Investigative Site
city: Melnik
country: Czechia
facility: Novartis Investigative Site
state: Czech Republic
city: Benesov
country: Czechia
facility: Novartis Investigative Site
city: Brandys nad Labem
country: Czechia
facility: Novartis Investigative Site
city: Kyjov
country: Czechia
facility: Novartis Investigative Site
city: Plzen
country: Czechia
facility: Novartis Investigative Site
city: Copenhagen NV
country: Denmark
facility: Novartis Investigative Site
city: Hvidovre
country: Denmark
facility: Novartis Investigative Site
city: Kohtla-Jarve
country: Estonia
facility: Novartis Investigative Site
city: Tallinn
country: Estonia
facility: Novartis Investigative Site
city: Tallinn
country: Estonia
facility: Novartis Investigative Site
city: Tartu
country: Estonia
facility: Novartis Investigative Site
city: Hannover
country: Germany
facility: Novartis Investigative Site
state: Niedersachsen
city: Peine
country: Germany
facility: Novartis Investigative Site
state: Niedersachsen
city: Warendorf
country: Germany
facility: Novartis Investigative Site
state: Nordrhein-Westfalen
city: Koblenz
country: Germany
facility: Novartis Investigative Site
state: Rheinland-Pfalz
city: Cottbus
country: Germany
facility: Novartis Investigative Site
state: Sachsen
city: Bad Woerishofen
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Bonn
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Erlangen
country: Germany
facility: Novartis Investigative Site
city: Frankfurt am Main
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Hagen
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Lubeck
country: Germany
facility: Novartis Investigative Site
city: Magdeburg
country: Germany
facility: Novartis Investigative Site
city: Marburg
country: Germany
facility: Novartis Investigative Site
city: Menden
country: Germany
facility: Novartis Investigative Site
city: Neu Isenburg
country: Germany
facility: Novartis Investigative Site
city: Oschatz
country: Germany
facility: Novartis Investigative Site
city: Potsdam
country: Germany
facility: Novartis Investigative Site
city: Potsdam
country: Germany
facility: Novartis Investigative Site
city: Rudersdorf
country: Germany
facility: Novartis Investigative Site
city: Schleswig
country: Germany
facility: Novartis Investigative Site
city: Solingen
country: Germany
facility: Novartis Investigative Site
city: Wiesloch
country: Germany
facility: Novartis Investigative Site
city: Thessaloniki
country: Greece
facility: Novartis Investigative Site
state: GR
city: Athens
country: Greece
facility: Novartis Investigative Site
city: Heraklion - Crete
country: Greece
facility: Novartis Investigative Site
city: Szazhalombatta
country: Hungary
facility: Novartis Investigative Site
state: HUN
city: Torokbalint
country: Hungary
facility: Novartis Investigative Site
state: Pest
city: Balassagyarmat
country: Hungary
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Szekszard
country: Hungary
facility: Novartis Investigative Site
city: Balvi
country: Latvia
facility: Novartis Investigative Site
state: LVA
city: Jurmala
country: Latvia
facility: Novartis Investigative Site
state: LVA
city: Liepaja
country: Latvia
facility: Novartis Investigative Site
state: LV
city: Riga
country: Latvia
facility: Novartis Investigative Site
state: LV
city: Daugavpils
country: Latvia
facility: Novartis Investigative Site
city: Kraslava
country: Latvia
facility: Novartis Investigative Site
city: Riga
country: Latvia
facility: Novartis Investigative Site
city: Riga
country: Latvia
facility: Novartis Investigative Site
city: Kaunas
country: Lithuania
facility: Novartis Investigative Site
state: LT
city: Klaipeda
country: Lithuania
facility: Novartis Investigative Site
city: Klaipeda
country: Lithuania
facility: Novartis Investigative Site
city: Utena
country: Lithuania
facility: Novartis Investigative Site
city: Vilnius
country: Lithuania
facility: Novartis Investigative Site
city: Vilnius
country: Lithuania
facility: Novartis Investigative Site
city: Alkmaar
country: Netherlands
facility: Novartis Investigative Site
city: Breda
country: Netherlands
facility: Novartis Investigative Site
city: Eindhoven
country: Netherlands
facility: Novartis Investigative Site
city: Zutphen
country: Netherlands
facility: Novartis Investigative Site
city: Wroclaw
country: Poland
facility: Novartis Investigative Site
state: Dolnoslaskie
city: Ostrowiec Swietokrzyskie
country: Poland
facility: Novartis Investigative Site
state: Swietokrzyskie
city: Bialystok
country: Poland
facility: Novartis Investigative Site
city: Bialystok
country: Poland
facility: Novartis Investigative Site
city: Bialystok
country: Poland
facility: Novartis Investigative Site
city: Bienkowka
country: Poland
facility: Novartis Investigative Site
city: Krakow
country: Poland
facility: Novartis Investigative Site
city: Lodz
country: Poland
facility: Novartis Investigative Site
city: Lublin
country: Poland
facility: Novartis Investigative Site
city: Ostrów Wielkopolski
country: Poland
facility: Novartis Investigative Site
city: Poznan
country: Poland
facility: Novartis Investigative Site
city: Poznan
country: Poland
facility: Novartis Investigative Site
city: Sopot
country: Poland
facility: Novartis Investigative Site
city: Tarnow
country: Poland
facility: Novartis Investigative Site
city: Wroclaw
country: Poland
facility: Novartis Investigative Site
city: Bucuresti
country: Romania
facility: Novartis Investigative Site
state: District 1
city: Timisoara
country: Romania
facility: Novartis Investigative Site
state: Timis
city: Arad
country: Romania
facility: Novartis Investigative Site
city: Arad
country: Romania
facility: Novartis Investigative Site
city: Brasov
country: Romania
facility: Novartis Investigative Site
city: Bucharest
country: Romania
facility: Novartis Investigative Site
city: Bucharest
country: Romania
facility: Novartis Investigative Site
city: Bucuresti
country: Romania
facility: Novartis Investigative Site
city: Cluj Napoca
country: Romania
facility: Novartis Investigative Site
city: Deva
country: Romania
facility: Novartis Investigative Site
city: Belgrade
country: Serbia
facility: Novartis Investigative Site
city: Beograd
country: Serbia
facility: Novartis Investigative Site
city: Knez Selo
country: Serbia
facility: Novartis Investigative Site
city: Kragujevac
country: Serbia
facility: Novartis Investigative Site
city: Valjevo
country: Serbia
facility: Novartis Investigative Site
city: Humenne
country: Slovakia
facility: Novartis Investigative Site
city: Poprad
country: Slovakia
facility: Novartis Investigative Site
city: Presov
country: Slovakia
facility: Novartis Investigative Site
city: Spisska Nova Ves
country: Slovakia
facility: Novartis Investigative Site
city: Malaga
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Centelles
country: Spain
facility: Novartis Investigative Site
state: Barcelona
city: Ponferrada
country: Spain
facility: Novartis Investigative Site
state: Castilla Y Leon
city: Canet de Mar
country: Spain
facility: Novartis Investigative Site
state: Cataluna
city: L´Hospitalet de Llobregat
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Alzira
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: San Juan de Alicante
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Merida
country: Spain
facility: Novartis Investigative Site
state: Extremadura
city: Leamington Spa
country: United Kingdom
facility: Novartis Investigative Site
state: Warwickshire
city: Crawley
country: United Kingdom
facility: Novartis Investigative Site
state: West Sussex
city: Bradford
country: United Kingdom
facility: Novartis Investigative Site
state: West Yorkshire
city: Bath
country: United Kingdom
facility: Novartis Investigative Site
city: Birmingham
country: United Kingdom
facility: Novartis Investigative Site
city: Birmingham
country: United Kingdom
facility: Novartis Investigative Site
city: Coventry
country: United Kingdom
facility: Novartis Investigative Site
city: Plymouth
country: United Kingdom
facility: Novartis Investigative Site
city: Wolverhampton
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: 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.