Chronic Obstructive Pulmonary Disease (COPD)Phase 4NCT02603393

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

A Phase 4 study testing QVA149, Tiotropium and Salmeterol/fluticasone in people with Chronic Obstructive Pulmonary Disease (COPD), run by Novartis Pharmaceuticals at 167 sites in 21 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Chronic Obstructive Pulmonary Disease (COPD)
What is being tested?: QVA149, Tiotropium and Salmeterol/fluticasone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,053 participants
Where: 167 sitesin 21 countries
Study dates: 20 Nov 2015to 18 Jul 2017
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

Who cannot join

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

Trial locations and contacts

167 sites in 21 countries.

Country

City, postcode or hospital

167 sites in 21 countries

Germany41 sites

Novartis Investigative Site
Bad Wörishofen, 86825
Novartis Investigative Site
Berlin, 10117
Novartis Investigative Site
Berlin, 10119
Novartis Investigative Site
Berlin, 10367
Novartis Investigative Site
Berlin, 10625
Novartis Investigative Site
Berlin, 10717
Novartis Investigative Site
Berlin, 10787
Novartis Investigative Site
Berlin, 10969
Novartis Investigative Site
Berlin, 12157
Novartis Investigative Site
Berlin, 12159
Novartis Investigative Site
Berlin, 12203
Novartis Investigative Site
Berlin, 13156
Novartis Investigative Site
Bonn, 53123
Novartis Investigative Site
Cottbus, Saxony, 03050
Novartis Investigative Site
Dresden, 01069
Novartis Investigative Site
Erlangen, 91052
Novartis Investigative Site
Frankfurt, 60596
Novartis Investigative Site
Frankfurt am Main, 60389
Novartis Investigative Site
Hagen, 58089
Novartis Investigative Site
Hamburg, 20354
Novartis Investigative Site
Hamburg, 22143
Novartis Investigative Site
Hanover, Lower Saxony, 30159
Novartis Investigative Site
Koblenz, Rhineland-Palatinate, 56068
Novartis Investigative Site
Leipzig, 04103
Novartis Investigative Site
Leipzig, 04109
Novartis Investigative Site
Leipzig, 04207
Novartis Investigative Site
Leipzig, 04357
Novartis Investigative Site
Lübeck, 23552
Novartis Investigative Site
Magdeburg, 39112
Novartis Investigative Site
Marburg, 35037
Novartis Investigative Site
Menden, 58706
Novartis Investigative Site
Neu-Isenburg, 63263
Novartis Investigative Site
Oschatz, 04758
Novartis Investigative Site
Peine, Lower Saxony, 31224
Novartis Investigative Site
Potsdam, 14467
Novartis Investigative Site
Potsdam, 14469
Novartis Investigative Site
Rüdersdorf, 15562
Novartis Investigative Site
Schleswig, 24837
Novartis Investigative Site
Solingen, 42651
Novartis Investigative Site
Warendorf, North Rhine-Westphalia, 48231
Novartis Investigative Site
Wiesloch, 69168

Other trials in Germany

Poland15 sites

Novartis Investigative Site
Bialystok, 15-044
Novartis Investigative Site
Bialystok, 15-270
Novartis Investigative Site
Bialystok, 15-351
Novartis Investigative Site
Bieńkówka, 34-212
Novartis Investigative Site
Krakow, 31-023
Novartis Investigative Site
Lodz, 90-153
Novartis Investigative Site
Lublin, 20-045
Novartis Investigative Site
Ostrów Wielkopolski, 63400
Novartis Investigative Site
Ostrowiec Swietokrzyskie, Świętokrzyskie Voivodeship, 27-400
Novartis Investigative Site
Poznan, 60-214
Novartis Investigative Site
Poznan, 60-823
Novartis Investigative Site
Sopot, 81-741
Novartis Investigative Site
Tarnów, 33-100
Novartis Investigative Site
Wroclaw, Lower Silesian Voivodeship, 53-301
Novartis Investigative Site
Wroclaw, 50-434

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Argentina11 sites

Novartis Investigative Site
CABA, Buenos Aires, C1425BEN
Novartis Investigative Site
CABA
Novartis Investigative Site
Ciudad Autonoma de Bs As, C1425FVH
Novartis Investigative Site
Concepción del Uruguay, Entre Ríos Province, 3260
Novartis Investigative Site
Lanus, Buenos Aires, B8000XAV
Novartis Investigative Site
Mar del Plata, Buenos Aires, 7600
Novartis Investigative Site
Mar del Plata, Buenos Aires, B7600FZN
Novartis Investigative Site
Mendoza, M5500CBA
Novartis Investigative Site
Quilmes, Buenos Aires, B1878FNR
Novartis Investigative Site
San Miguel de Tucumán, Tucumán Province, 4000
Novartis Investigative Site
San Miguel de Tucumán, Tucumán Province, T4000IFL

Other trials in Argentina

Canada11 sites

Novartis Investigative Site
Burlington, Ontario, L7N 3V2
Novartis Investigative Site
Gatineau, Quebec, J8Y 6S8
Novartis Investigative Site
Moncton, New Brunswick, E1G 1A7
Novartis Investigative Site
Québec, Quebec, G1G 3Y8
Novartis Investigative Site
Québec, Quebec, G1W 4R4
Novartis Investigative Site
Québec, Quebec, G3K 2P8
Novartis Investigative Site
Saint-Charles-Borromée, Quebec, J6E 2B4
Novartis Investigative Site
Toronto, Ontario, M5T 3A9
Novartis Investigative Site
Toronto, Ontario, M6H 3M2
Novartis Investigative Site
Vancouver, British Columbia, V5Z 4E1
Novartis Investigative Site
Victoriaville, Quebec, G6P 6P6

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Romania10 sites

Novartis Investigative Site
Arad, 310013
Novartis Investigative Site
Arad, 310416
Novartis Investigative Site
Brasov, 500086
Novartis Investigative Site
Bucharest, District 1, 10457
Novartis Investigative Site
Bucharest, 012051
Novartis Investigative Site
Bucharest, 050159
Novartis Investigative Site
Bucharest, 303330
Novartis Investigative Site
Cluj-Napoca, 400371
Novartis Investigative Site
Deva, 330162
Novartis Investigative Site
Timișoara, Timiș County, 300310

Other trials in Romania

United Kingdom9 sites

Novartis Investigative Site
Bath, BA2 3HT
Novartis Investigative Site
Birmingham, B15 2TH
Novartis Investigative Site
Birmingham, B9 5SS
Novartis Investigative Site
Bradford, West Yorkshire, BD9 6RJ
Novartis Investigative Site
Coventry, CV2 2DX
Novartis Investigative Site
Crawley, West Sussex, RH10 7DX
Novartis Investigative Site
Plymouth, PL5 3JB
Novartis Investigative Site
Royal Leamington Spa, Warwickshire, CV32 4RA
Novartis Investigative Site
Wolverhampton, WV10 0QP

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Latvia8 sites

Novartis Investigative Site
Balvi, LVA, 4501
Novartis Investigative Site
Daugavpils, LV-5401
Novartis Investigative Site
Jūrmala, LVA, LV-2015
Novartis Investigative Site
Krāslava, 5601
Novartis Investigative Site
Liepāja, LV, LV-3414
Novartis Investigative Site
Riga, LV, 1011
Novartis Investigative Site
Riga, LV 1002
Novartis Investigative Site
Riga, LV-1038

Other trials in Latvia

Spain8 sites

Novartis Investigative Site
Alzira, Valencia, 46600
Novartis Investigative Site
Canet de Mar, Catalonia, 08360
Novartis Investigative Site
Centelles, Barcelona, 08540
Novartis Investigative Site
L'Hospitalet de Llobregat, Catalonia, 08907
Novartis Investigative Site
Málaga, Andalusia, 29010
Novartis Investigative Site
Mérida, Extremadura, 06800
Novartis Investigative Site
Ponferrada, Castille and León, 24400
Novartis Investigative Site
Sant Joan d'Alacant, Valencia, 03550

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Lithuania6 sites

Novartis Investigative Site
Kaunas, LT, LT-50128
Novartis Investigative Site
Klaipėda, LT-92231
Novartis Investigative Site
Klaipėda, LT-92288
Novartis Investigative Site
Utena, LT-28151
Novartis Investigative Site
Vilnius, 06122
Novartis Investigative Site
Vilnius, LT-08661

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Austria5 sites

Novartis Investigative Site
Amstetten, 3300
Novartis Investigative Site
Feldbach, 8330
Novartis Investigative Site
Feldkirch, 6800
Novartis Investigative Site
Grieskirchen, 4710
Novartis Investigative Site
Thalheim bei Wels, 4600

Other trials in Austria

Belgium5 sites

Novartis Investigative Site
Antwerp, 2060
Novartis Investigative Site
Éghezée, 5310
Novartis Investigative Site
Erpent, 5100
Novartis Investigative Site
Hasselt, 3500
Novartis Investigative Site
Turnhout, 2300

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Czechia5 sites

Novartis Investigative Site
Benešov, 25601
Novartis Investigative Site
Brandýs nad Labem, 25001
Novartis Investigative Site
Kyjov, 697 33
Novartis Investigative Site
Mělník, Czech Republic, 267 01
Novartis Investigative Site
Pilsen, 32800

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Hungary5 sites

Novartis Investigative Site
Balassagyarmat, 2660
Novartis Investigative Site
Budapest, 1121
Novartis Investigative Site
Százhalombatta, HUN, 2440
Novartis Investigative Site
Szekszárd, 7100
Novartis Investigative Site
Törökbálint, Pest County, 2045

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Serbia5 sites

Novartis Investigative Site
Belgrade, Serbia, 11000
Novartis Investigative Site
Belgrade, 11000
Novartis Investigative Site
Knez-Selo, 18204
Novartis Investigative Site
Kragujevac, 34000
Novartis Investigative Site
Valjevo, 14000

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Bulgaria4 sites

Novartis Investigative Site
Gabrovo, 5300
Novartis Investigative Site
Rousse, 7000
Novartis Investigative Site
Stara Zagora, 6000
Novartis Investigative Site
Varna, 9000

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Estonia4 sites

Novartis Investigative Site
Kohtla-Järve, 30322
Novartis Investigative Site
Tallinn, 10138
Novartis Investigative Site
Tallinn, 13419
Novartis Investigative Site
Tartu, 51014

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Netherlands4 sites

Novartis Investigative Site
Alkmaar, 1814HB
Novartis Investigative Site
Breda, 4819 EV
Novartis Investigative Site
Eindhoven, 5623 EJ
Novartis Investigative Site
Zutphen, 7207 AE

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Slovakia4 sites

Novartis Investigative Site
Humenné, 06601
Novartis Investigative Site
Poprad, 058 01
Novartis Investigative Site
Prešov, 080 01
Novartis Investigative Site
Spišská Nová Ves, 052 01

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Greece3 sites

Novartis Investigative Site
Athens, 106 76
Novartis Investigative Site
Heraklion - Crete, Greece, 711 10
Novartis Investigative Site
Thessaloniki, GR, 570 10

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Croatia2 sites

Novartis Investigative Site
Rijeka, HRV, 51000
Novartis Investigative Site
Zagreb, 10000

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Denmark2 sites

Novartis Investigative Site
Copenhagen NV, 2400
Novartis Investigative Site
Hvidovre, 2650

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About this study

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

Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Being tested: QVA149, Tiotropium, Salmeterol/fluticasone
Keywords: COPD, QVA149
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

QVA149Drug
QVA149 will be supplied in a capsule form in blister packs for use in the Novartis Concept 1 SDDPI
TiotropiumDrug
Tiotropium will be supplied as commercially available blisters, delivered via HandiHaler®
Salmeterol/fluticasoneDrug
Salmeterol/fluticasone propionate dry inhalation powder delivered via Accuhaler™

Study groups in NCT02603393
Study group	Role	What they receive
QVA149	Experimental	Not described Receives: Drug: QVA149
Tiotropium + salmeterol/fluticasone	Active comparator	Not described Receives: Drug: Tiotropium; Drug: Salmeterol/fluticasone

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline, 26 weeks

Secondary outcomes (10)

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.
Measured: 26 weeks
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 26 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Nov 201518 Jul 2017

First posted11 Nov 2015 (estimated)
Study start20 Nov 2015
Primary completion18 Jul 2017
Study completion18 Jul 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,053 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02603393
Sponsor's protocol ID: CQVA149A2316
Other IDs: 2015-000114-22, 2015
Status last verified: Jan 2019
First submitted: 17 Sep 2015
Last updated: 29 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 29779416

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 29 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02603393
Acronym / sponsor ID: CQVA149A2316
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD, QVA149
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,053 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 20 Nov 2015 (actual)
Primary completion: 18 Jul 2017 (actual)
Study completion: 18 Jul 2017 (actual)
First posted: 11 Nov 2015 (estimated)
Results: Posted 29 Apr 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
QVA149	Experimental	Drug: QVA149
Tiotropium + salmeterol/fluticasone	Active comparator	Drug: Tiotropium, Drug: Salmeterol/fluticasone

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
QVA149QVA149 will be supplied in a capsule form in blister packs for use in the Novartis Concept 1 SDDPI	Drug	QVA149
TiotropiumTiotropium will be supplied as commercially available blisters, delivered via HandiHaler®	Drug	Tiotropium + salmeterol/fluticasone
Salmeterol/fluticasoneSalmeterol/fluticasone propionate dry inhalation powder delivered via Accuhaler™	Drug	Tiotropium + salmeterol/fluticasone

Primary outcome

Mean Change From Baseline in Post-dose Trough FEV1
Time frame: Baseline, 26 weeks
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.

10 secondary outcomes

Annualized Rate of Moderate or Severe COPD Exacerbations
Time frame: 26 weeks
Annualized Rate of COPD Exacerbations Requiring Treatment With Systemic Glucocorticosteroids and/or Antibiotics, Moderate Exacerbations Only
Time frame: 26 weeks
Annualized Rate of COPD Exacerbations Requiring Hospitalisation
Time frame: 26 weeks
Mean Change From Baseline in Pre-dose Trough FEV1
Time frame: 26 weeks
Mean Change From Baseline in St. George's Respiratory Questionnaire
Time frame: Baseline, 12 weeks
Mean Change From Baseline in St. George's Respiratory Questionnaire
Time frame: Baseline, 26 weeks
Transition Dyspnea Index (TDI) Score
Time frame: 12 weeks
Transition Dyspnea Index (TDI) Score
Time frame: 26 weeks
Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication
Time frame: Baseline, 26 weeks
Mean Change From Baseline in Forced Vital Capacity (FVC)
Time frame: Baseline, 26 weeks

Results and safety

Results posted to the registry on 29 Apr 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
QVA149	527	456
Tiotropium + Salmeterol/Fluticasone	526	472

Primary outcome: Mean Change From Baseline in Post-dose Trough FEV1

Time frame: Baseline, 26 weeks. Least squares mean (Standard Error). Unit: Liters

Measure	QVA149 n = 527	Tiotropium + Salmeterol/Fluticasone n = 526
Value	-0.029 (0.0119)	-0.003 (0.0115)

QVA149 vs Tiotropium + Salmeterol/Fluticasone: Mean Difference (Final Values): -0.026 (95% CI -0.053 to 0.001), p = 0.0404, Mixed Model for Repeated Measures Analys

Population analysed: 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.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: The study consists of four epochs: screening (1 week), run-in (4 weeks), blinded treatment (26 weeks) and follow-up (4 weeks).. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
QVA149	32 of 527 (6.1%)	398 of 527 (75.5%)	4 of 527
Tio+Salm/Flut	34 of 526 (6.5%)	392 of 526 (74.5%)	5 of 526

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29779416Chapman 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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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Novartis Pharmaceuticals study director

Novartis Pharmaceuticals

167 sites in 21 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing QVA149, Tiotropium and Salmeterol/fluticasone in people with Chronic Obstructive Pulmonary Disease (COPD), run by Novartis Pharmaceuticals at 167 sites in 21 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 167 sites in Germany, Poland, Argentina, Canada, Romania and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change From Baseline in Post-dose Trough FEV1 (time frame: Baseline, 26 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02603393, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2019.