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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

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

QVA149

Tiotropium

Salmeterol/fluticasone

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring COPD, QVA149

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

QVA149

Tiotropium + salmeterol/fluticasone

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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

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.

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.

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.

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

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.

Transition Dyspnea Index (TDI) Score

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.

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 Information

NCT ID

NCT02603393

First Posted

September 17, 2015

Last Updated

January 25, 2019

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT02603393

Brief Title

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

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

November 20, 2015 (Actual)

Primary Completion Date

July 18, 2017 (Actual)

Study Completion Date

July 18, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD, QVA149

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

1053 (Actual)

8. Arms, Groups, and Interventions

Arm Title

QVA149

Arm Type

Experimental

Arm Title

Tiotropium + salmeterol/fluticasone

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

QVA149

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Tiotropium

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Salmeterol/fluticasone

Intervention Description

Salmeterol/fluticasone propionate dry inhalation powder delivered via Accuhaler™

Primary Outcome Measure Information:

Title

Mean Change From Baseline in Post-dose Trough FEV1

Description

Time Frame

Baseline, 26 weeks

Secondary Outcome Measure Information:

Title

Annualized Rate of Moderate or Severe COPD Exacerbations

Description

Time Frame

26 weeks

Title

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

Description

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

Time Frame

26 weeks

Title

Annualized Rate of COPD Exacerbations Requiring Hospitalisation

Description

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.

Time Frame

26 weeks

Title

Mean Change From Baseline in Pre-dose Trough FEV1

Description

Time Frame

26 weeks

Title

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

Description

Time Frame

Baseline, 12 weeks

Title

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

Description

Time Frame

Baseline, 26 weeks

Title

Transition Dyspnea Index (TDI) Score

Description

Time Frame

12 weeks

Title

Transition Dyspnea Index (TDI) Score

Description

Time Frame

26 weeks

Title

Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication

Description

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.

Time Frame

Baseline, 26 weeks

Title

Mean Change From Baseline in Forced Vital Capacity (FVC)

Description

Time Frame

Baseline, 26 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1425BEN

Country

Argentina

Facility Name

Novartis Investigative Site

City

Lanus

State/Province

Buenos Aires

ZIP/Postal Code

B8000XAV

Country

Argentina

Facility Name

Novartis Investigative Site

City

Mar del Plata

State/Province

Buenos Aires

ZIP/Postal Code

7600

Country

Argentina

Facility Name

Novartis Investigative Site

City

Mar del Plata

State/Province

Buenos Aires

ZIP/Postal Code

B7600FZN

Country

Argentina

Facility Name

Novartis Investigative Site

City

Quilmes

State/Province

Buenos Aires

ZIP/Postal Code

B1878FNR

Country

Argentina

Facility Name

Novartis Investigative Site

City

Concepcion del Uruguay

State/Province

Entre Rios

ZIP/Postal Code

3260

Country

Argentina

Facility Name

Novartis Investigative Site

City

San Miguel de Tucuman

State/Province

Tucuman

ZIP/Postal Code

4000

Country

Argentina

Facility Name

Novartis Investigative Site

City

San Miguel de Tucuman

State/Province

Tucuman

ZIP/Postal Code

T4000IFL

Country

Argentina

Facility Name

Novartis Investigative Site

City

Caba

Country

Argentina

Facility Name

Novartis Investigative Site

City

Ciudad Autonoma de Bs As

ZIP/Postal Code

C1425FVH

Country

Argentina

Facility Name

Novartis Investigative Site

City

Mendoza

ZIP/Postal Code

M5500CBA

Country

Argentina

Facility Name

Novartis Investigative Site

City

Amstetten

ZIP/Postal Code

3300

Country

Austria

Facility Name

Novartis Investigative Site

City

Feldbach

ZIP/Postal Code

8330

Country

Austria

Facility Name

Novartis Investigative Site

City

Feldkirch

ZIP/Postal Code

6800

Country

Austria

Facility Name

Novartis Investigative Site

City

Grieskirchen

ZIP/Postal Code

4710

Country

Austria

Facility Name

Novartis Investigative Site

City

Thalheim bei Wels

ZIP/Postal Code

4600

Country

Austria

Facility Name

Novartis Investigative Site

City

Antwerpen

ZIP/Postal Code

2060

Country

Belgium

Facility Name

Novartis Investigative Site

City

Eghezee

ZIP/Postal Code

5310

Country

Belgium

Facility Name

Novartis Investigative Site

City

Erpent

ZIP/Postal Code

5100

Country

Belgium

Facility Name

Novartis Investigative Site

City

Hasselt

ZIP/Postal Code

3500

Country

Belgium

Facility Name

Novartis Investigative Site

City

Turnhout

ZIP/Postal Code

2300

Country

Belgium

Facility Name

Novartis Investigative Site

City

Gabrovo

ZIP/Postal Code

5300

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Ruse

ZIP/Postal Code

7000

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Stara Zagora

ZIP/Postal Code

6000

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Varna

ZIP/Postal Code

9000

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 4E1

Country

Canada

Facility Name

Novartis Investigative Site

City

Moncton

State/Province

New Brunswick

ZIP/Postal Code

E1G 1A7

Country

Canada

Facility Name

Novartis Investigative Site

City

Burlington

State/Province

Ontario

ZIP/Postal Code

L7N 3V2

Country

Canada

Facility Name

Novartis Investigative Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5T 3A9

Country

Canada

Facility Name

Novartis Investigative Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M6H 3M2

Country

Canada

Facility Name

Novartis Investigative Site

City

Gatineau

State/Province

Quebec

ZIP/Postal Code

J8Y 6S8

Country

Canada

Facility Name

Novartis Investigative Site

City

St-Charles-Borromée

State/Province

Quebec

ZIP/Postal Code

J6E 2B4

Country

Canada

Facility Name

Novartis Investigative Site

City

Victoriaville

State/Province

Quebec

ZIP/Postal Code

G6P 6P6

Country

Canada

Facility Name

Novartis Investigative Site

City

Quebec

ZIP/Postal Code

G1G 3Y8

Country

Canada

Facility Name

Novartis Investigative Site

City

Quebec

ZIP/Postal Code

G1W 4R4

Country

Canada

Facility Name

Novartis Investigative Site

City

Quebec

ZIP/Postal Code

G3K 2P8

Country

Canada

Facility Name

Novartis Investigative Site

City

Rijeka

State/Province

HRV

ZIP/Postal Code

51000

Country

Croatia

Facility Name

Novartis Investigative Site

City

Zagreb

ZIP/Postal Code

10000

Country

Croatia

Facility Name

Novartis Investigative Site

City

Melnik

State/Province

Czech Republic

ZIP/Postal Code

267 01

Country

Czechia

Facility Name

Novartis Investigative Site

City

Benesov

ZIP/Postal Code

25601

Country

Czechia

Facility Name

Novartis Investigative Site

City

Brandys nad Labem

ZIP/Postal Code

25001

Country

Czechia

Facility Name

Novartis Investigative Site

City

Kyjov

ZIP/Postal Code

697 33

Country

Czechia

Facility Name

Novartis Investigative Site

City

Plzen

ZIP/Postal Code

32800

Country

Czechia

Facility Name

Novartis Investigative Site

City

Copenhagen NV

ZIP/Postal Code

2400

Country

Denmark

Facility Name

Novartis Investigative Site

City

Hvidovre

ZIP/Postal Code

2650

Country

Denmark

Facility Name

Novartis Investigative Site

City

Kohtla-Jarve

ZIP/Postal Code

30322

Country

Estonia

Facility Name

Novartis Investigative Site

City

Tallinn

ZIP/Postal Code

10138

Country

Estonia

Facility Name

Novartis Investigative Site

City

Tallinn

ZIP/Postal Code

13419

Country

Estonia

Facility Name

Novartis Investigative Site

City

Tartu

ZIP/Postal Code

51014

Country

Estonia

Facility Name

Novartis Investigative Site

City

Hannover

State/Province

Niedersachsen

ZIP/Postal Code

30159

Country

Germany

Facility Name

Novartis Investigative Site

City

Peine

State/Province

Niedersachsen

ZIP/Postal Code

31224

Country

Germany

Facility Name

Novartis Investigative Site

City

Warendorf

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

48231

Country

Germany

Facility Name

Novartis Investigative Site

City

Koblenz

State/Province

Rheinland-Pfalz

ZIP/Postal Code

56068

Country

Germany

Facility Name

Novartis Investigative Site

City

Cottbus

State/Province

Sachsen

ZIP/Postal Code

03050

Country

Germany

Facility Name

Novartis Investigative Site

City

Bad Woerishofen

ZIP/Postal Code

86825

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10119

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10367

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10625

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10717

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10787

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10969

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

12157

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

12159

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

12203

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

13156

Country

Germany

Facility Name

Novartis Investigative Site

City

Bonn

ZIP/Postal Code

53123

Country

Germany

Facility Name

Novartis Investigative Site

City

Dresden

ZIP/Postal Code

01069

Country

Germany

Facility Name

Novartis Investigative Site

City

Erlangen

ZIP/Postal Code

91052

Country

Germany

Facility Name

Novartis Investigative Site

City

Frankfurt am Main

ZIP/Postal Code

60389

Country

Germany

Facility Name

Novartis Investigative Site

City

Frankfurt

ZIP/Postal Code

60596

Country

Germany

Facility Name

Novartis Investigative Site

City

Hagen

ZIP/Postal Code

58089

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

20354

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

22143

Country

Germany

Facility Name

Novartis Investigative Site

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

Novartis Investigative Site

City

Leipzig

ZIP/Postal Code

04109

Country

Germany

Facility Name

Novartis Investigative Site

City

Leipzig

ZIP/Postal Code

04207

Country

Germany

Facility Name

Novartis Investigative Site

City

Leipzig

ZIP/Postal Code

04357

Country

Germany

Facility Name

Novartis Investigative Site

City

Lubeck

ZIP/Postal Code

23552

Country

Germany

Facility Name

Novartis Investigative Site

City

Magdeburg

ZIP/Postal Code

39112

Country

Germany

Facility Name

Novartis Investigative Site

City

Marburg

ZIP/Postal Code

35037

Country

Germany

Facility Name

Novartis Investigative Site

City

Menden

ZIP/Postal Code

58706

Country

Germany

Facility Name

Novartis Investigative Site

City

Neu Isenburg

ZIP/Postal Code

63263

Country

Germany

Facility Name

Novartis Investigative Site

City

Oschatz

ZIP/Postal Code

04758

Country

Germany

Facility Name

Novartis Investigative Site

City

Potsdam

ZIP/Postal Code

14467

Country

Germany

Facility Name

Novartis Investigative Site

City

Potsdam

ZIP/Postal Code

14469

Country

Germany

Facility Name

Novartis Investigative Site

City

Rudersdorf

ZIP/Postal Code

15562

Country

Germany

Facility Name

Novartis Investigative Site

City

Schleswig

ZIP/Postal Code

24837

Country

Germany

Facility Name

Novartis Investigative Site

City

Solingen

ZIP/Postal Code

42651

Country

Germany

Facility Name

Novartis Investigative Site

City

Wiesloch

ZIP/Postal Code

69168

Country

Germany

Facility Name

Novartis Investigative Site

City

Thessaloniki

State/Province

ZIP/Postal Code

570 10

Country

Greece

Facility Name

Novartis Investigative Site

City

Athens

ZIP/Postal Code

106 76

Country

Greece

Facility Name

Novartis Investigative Site

City

Heraklion - Crete

ZIP/Postal Code

711 10

Country

Greece

Facility Name

Novartis Investigative Site

City

Szazhalombatta

State/Province

HUN

ZIP/Postal Code

2440

Country

Hungary

Facility Name

Novartis Investigative Site

City

Torokbalint

State/Province

Pest

ZIP/Postal Code

2045

Country

Hungary

Facility Name

Novartis Investigative Site

City

Balassagyarmat

ZIP/Postal Code

2660

Country

Hungary

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1121

Country

Hungary

Facility Name

Novartis Investigative Site

City

Szekszard

ZIP/Postal Code

7100

Country

Hungary

Facility Name

Novartis Investigative Site

City

Balvi

State/Province

LVA

ZIP/Postal Code

4501

Country

Latvia

Facility Name

Novartis Investigative Site

City

Jurmala

State/Province

LVA

ZIP/Postal Code

LV-2015

Country

Latvia

Facility Name

Novartis Investigative Site

City

Liepaja

State/Province

ZIP/Postal Code

LV-3414

Country

Latvia

Facility Name

Novartis Investigative Site

City

Riga

State/Province

ZIP/Postal Code

1011

Country

Latvia

Facility Name

Novartis Investigative Site

City

Daugavpils

ZIP/Postal Code

LV-5401

Country

Latvia

Facility Name

Novartis Investigative Site

City

Kraslava

ZIP/Postal Code

5601

Country

Latvia

Facility Name

Novartis Investigative Site

City

Riga

ZIP/Postal Code

LV 1002

Country

Latvia

Facility Name

Novartis Investigative Site

City

Riga

ZIP/Postal Code

LV-1038

Country

Latvia

Facility Name

Novartis Investigative Site

City

Kaunas

State/Province

ZIP/Postal Code

LT-50128

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Klaipeda

ZIP/Postal Code

LT-92231

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Klaipeda

ZIP/Postal Code

LT-92288

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Utena

ZIP/Postal Code

LT-28151

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Vilnius

ZIP/Postal Code

06122

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Vilnius

ZIP/Postal Code

LT-08661

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Alkmaar

ZIP/Postal Code

1814HB

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Breda

ZIP/Postal Code

4819 EV

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Eindhoven

ZIP/Postal Code

5623 EJ

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Zutphen

ZIP/Postal Code

7207 AE

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Wroclaw

State/Province

Dolnoslaskie

ZIP/Postal Code

53-301

Country

Poland

Facility Name

Novartis Investigative Site

City

Ostrowiec Swietokrzyskie

State/Province

Swietokrzyskie

ZIP/Postal Code

27-400

Country

Poland

Facility Name

Novartis Investigative Site

City

Bialystok

ZIP/Postal Code

15-044

Country

Poland

Facility Name

Novartis Investigative Site

City

Bialystok

ZIP/Postal Code

15-270

Country

Poland

Facility Name

Novartis Investigative Site

City

Bialystok

ZIP/Postal Code

15-351

Country

Poland

Facility Name

Novartis Investigative Site

City

Bienkowka

ZIP/Postal Code

34-212

Country

Poland

Facility Name

Novartis Investigative Site

City

Krakow

ZIP/Postal Code

31-023

Country

Poland

Facility Name

Novartis Investigative Site

City

Lodz

ZIP/Postal Code

90-153

Country

Poland

Facility Name

Novartis Investigative Site

City

Lublin

ZIP/Postal Code

20-045

Country

Poland

Facility Name

Novartis Investigative Site

City

Ostrów Wielkopolski

ZIP/Postal Code

63400

Country

Poland

Facility Name

Novartis Investigative Site

City

Poznan

ZIP/Postal Code

60-214

Country

Poland

Facility Name

Novartis Investigative Site

City

Poznan

ZIP/Postal Code

60-823

Country

Poland

Facility Name

Novartis Investigative Site

City

Sopot

ZIP/Postal Code

81-741

Country

Poland

Facility Name

Novartis Investigative Site

City

Tarnow

ZIP/Postal Code

33-100

Country

Poland

Facility Name

Novartis Investigative Site

City

Wroclaw

ZIP/Postal Code

50-434

Country

Poland

Facility Name

Novartis Investigative Site

City

Bucuresti

State/Province

District 1

ZIP/Postal Code

10457

Country

Romania

Facility Name

Novartis Investigative Site

City

Timisoara

State/Province

Timis

ZIP/Postal Code

300310

Country

Romania

Facility Name

Novartis Investigative Site

City

Arad

ZIP/Postal Code

310013

Country

Romania

Facility Name

Novartis Investigative Site

City

Arad

ZIP/Postal Code

310416

Country

Romania

Facility Name

Novartis Investigative Site

City

Brasov

ZIP/Postal Code

500086

Country

Romania

Facility Name

Novartis Investigative Site

City

Bucharest

ZIP/Postal Code

050159

Country

Romania

Facility Name

Novartis Investigative Site

City

Bucharest

ZIP/Postal Code

303330

Country

Romania

Facility Name

Novartis Investigative Site

City

Bucuresti

ZIP/Postal Code

012051

Country

Romania

Facility Name

Novartis Investigative Site

City

Cluj Napoca

ZIP/Postal Code

400371

Country

Romania

Facility Name

Novartis Investigative Site

City

Deva

ZIP/Postal Code

330162

Country

Romania

Facility Name

Novartis Investigative Site

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Novartis Investigative Site

City

Beograd

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Novartis Investigative Site

City

Knez Selo

ZIP/Postal Code

18204

Country

Serbia

Facility Name

Novartis Investigative Site

City

Kragujevac

ZIP/Postal Code

34000

Country

Serbia

Facility Name

Novartis Investigative Site

City

Valjevo

ZIP/Postal Code

14000

Country

Serbia

Facility Name

Novartis Investigative Site

City

Humenne

ZIP/Postal Code

06601

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Poprad

ZIP/Postal Code

058 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Presov

ZIP/Postal Code

080 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Spisska Nova Ves

ZIP/Postal Code

052 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Malaga

State/Province

Andalucia

ZIP/Postal Code

29010

Country

Spain

Facility Name

Novartis Investigative Site

City

Centelles

State/Province

Barcelona

ZIP/Postal Code

08540

Country

Spain

Facility Name

Novartis Investigative Site

City

Ponferrada

State/Province

Castilla Y Leon

ZIP/Postal Code

24400

Country

Spain

Facility Name

Novartis Investigative Site

City

Canet de Mar

State/Province

Cataluna

ZIP/Postal Code

08360

Country

Spain

Facility Name

Novartis Investigative Site

City

L´Hospitalet de Llobregat

State/Province

Cataluña

ZIP/Postal Code

08907

Country

Spain

Facility Name

Novartis Investigative Site

City

Alzira

State/Province

Comunidad Valenciana

ZIP/Postal Code

46600

Country

Spain

Facility Name

Novartis Investigative Site

City

San Juan de Alicante

State/Province

Comunidad Valenciana

ZIP/Postal Code

03550

Country

Spain

Facility Name

Novartis Investigative Site

City

Merida

State/Province

Extremadura

ZIP/Postal Code

06800

Country

Spain

Facility Name

Novartis Investigative Site

City

Leamington Spa

State/Province

Warwickshire

ZIP/Postal Code

CV32 4RA

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Crawley

State/Province

West Sussex

ZIP/Postal Code

RH10 7DX

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Bradford

State/Province

West Yorkshire

ZIP/Postal Code

BD9 6RJ

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Bath

ZIP/Postal Code

BA2 3HT

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Birmingham

ZIP/Postal Code

B15 2TH

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Birmingham

ZIP/Postal Code

B9 5SS

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Coventry

ZIP/Postal Code

CV2 2DX

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Plymouth

ZIP/Postal Code

PL5 3JB

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Wolverhampton

ZIP/Postal Code

WV10 0QP

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

29779416

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.

Results Reference

derived

Learn more about this trial

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

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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

Chronic Obstructive Pulmonary Disease (COPD)

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial