AzTrials
AzTrials

Chronic Obstructive Pulmonary Disease (COPD)Phase 3NCT01782326

QVA vs. Salmeterol/Fluticasone, 52-week Exacerbation Study, FLAME (EFfect of Indacaterol Glycopyronium Vs Fluticasone Salmeterol on COPD Exacerbations)

A Phase 3 study testing QVA149 and Long acting B2 agonist (LABA) and inhaled corticosteroid (ICS) in people with Chronic Obstructive Pulmonary Disease (COPD), run by Novartis Pharmaceuticals at 499 sites in 43 countries.

Completed

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

Official record
Search all trials

Trial summary

This study will assess the efficacy, safety and tolerability of QVA149 in patients with moderate to very severe COPD. Read more about this study

Who is it for?
Ages 40 years and older
What is being tested?
QVA149 and Long acting B2 agonist (LABA) and inhaled corticosteroid (ICS)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,362 participants
Where
499 sitesin 43 countries
Study dates
Jul 2013to Sep 2015
Phase
Phase 3
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

  • Written informed consent must be obtained before any assessment is performed
  • Male or female adults aged ≥40 years
  • Patients with stable Chronic Obstructive Pulmonary Disease ( COPD) according to the current GOLD strategy (GOLD 2011)
  • Current or ex-smokers who have a smoking history of at least 10 pack years. (Ten pack-years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years)
  • Patients with a post-bronchodilator Forced Expiratory Volume in one second (FEV1) ≥25 and < 60% of the predicted normal value, and post-bronchodilator FEV1/FVC (Forced Vital Capacity) < 0.70 at day -28. (Post refers to 1 hour after sequential inhalation of 84 µg (or equivalent dose) of ipratropium bromide and 400 µg of salbutamol)
  • A documented history of at least 1 COPD exacerbation in the previous 12 months that required treatment with systemic glucocorticosteroids and/or antibiotics
  • Patients taking stable COPD medication (at least 60 days) prior to day 28
  • Patients with an mMRC grade of at least 2 at day 28

Who cannot join

  • Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG (human Chorionic Gonadotropin) laboratory test
  • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment. Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential
  • Patients with Type I or uncontrolled Type II diabetes
  • Patients with a history of long QT syndrome or whose QTc measured at day 28 (Fridericia method) is prolonged (>450 ms for males and females) and confirmed by a central assessor. These patients should not be re-screened
  • Patients who have a clinically significant ECG abnormality prior to randomization. (These patients should not be re-screened)
  • Patients who have a clinically significant laboratory abnormality at screening
Show all 33Show fewer
  • Patients who have clinically significant renal, cardiovascular (such as but not limited to unstable ischemic heart disease, NYHA Class III/IV left ventricular failure, myocardial infarction), arrhythmia (see below for patients with atrial fibrillation), neurological, endocrine, immunological, psychiatric, gastrointestinal, hepatic, or hematological abnormalities which could interfere with the assessment of the efficacy and safety of the study treatment
  • Patients with paroxysmal (e.g. intermittent) atrial fibrillation are excluded
  • Patients with persistent atrial fibrillation as defined by continuous atrial fibrillation for at least 6 months and controlled with a rate control strategy (i.e., selective beta blocker, calcium channel blocker, pacemaker placement, digoxin or ablation therapy) for at least 6 months may be considered for inclusion. In such patients, atrial fibrillation must be present at both pre-randomization visits, with a resting ventricular rate < 100/min. At screening the atrial fibrillation must be confirmed by central reading
  • Patients contraindicated for treatment with, or having a history of reactions/ hypersensitivity to any of the following inhaled drugs, drugs of a similar class or any component thereof: anticholinergic agents, long and short acting beta-2 agonists, sympathomimetic amines, lactose or any of the other excipients of trial medication
  • Patients with a history of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin
  • Patients with narrow-angle glaucoma, symptomatic benign prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment or urinary retention. Benign Prostatic Hyperplasia (BPH) patients who are stable on treatment can be considered
  • Patients who have not achieved an acceptable spirometry results at screening in accordance with American Thoracic Society (ATS)/European Respiratory Society (ERS) criteria for acceptability (one retest may be performed for patients that don't meet the acceptability criteria)
  • Patients who have had a COPD exacerbation that required treatment with antibiotics and/or systemic corticosteroids and/or hospitalization in the 6 weeks prior to screening
  • Patients who develop a COPD exacerbation of any severity (mild/moderate/severe) between screening and treatment 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
  • Patients who have had a respiratory tract infection within 4 weeks prior to screening
  • Patients who develop a respiratory tract infection between screening and prior to treatment will not be eligible, but will be permitted to be re-screened 4 weeks after the resolution of the respiratory tract infection
  • Patients requiring long term oxygen therapy prescribed for >12 hours per day
  • Patients with any history of asthma
  • Patients with an onset of respiratory symptoms, including a COPD diagnosis prior to age 40 years
  • Patients with a blood eosinophil count > 600/mm3 at screening
  • Patients with allergic rhinitis who use a H1 antagonist or intra-nasal corticosteroids intermittently (treatment with a stable dose or regimen is permitted)
  • Patients with concomitant pulmonary disease (e.g. lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension)
  • Patients with clinically significant bronchiectasis
  • Patients with a diagnosis of α-1 anti-trypsin deficiency
  • Patients with active pulmonary tuberculosis, unless confirmed by imaging to be no longer active
  • Patients with pulmonary lobectomy or lung volume reduction surgery or lung transplantation
  • Patients participating in or planning to participate in the active phase of a supervised pulmonary rehabilitation program during the study. (Maintenance program is permitted.)
  • Patients receiving any medications in the classes listed in the protocol
  • Patients receiving any COPD related medications in the classes specified in the protocol must undergo the required washout period prior to screening and follow the adjustment to treatment program
  • Use of other investigational drugs/devices (approved or unapproved) at the time of enrollment, or within 30 days or 5 half-lives of screening, whichever is longer
  • Patients unable to use an electronic patient diary and EXACT pro diary
  • Patients unable to use a dry powder inhaler device, Metered Dose Inhaler (MDI) or a pressurized MDI (rescue medication) or comply with the study regimen.

Trial locations and contacts

499 sites in 43 countries.

499 sites in 43 countries

Germany70 sites

  • Novartis Investigative Site

    Aschaffenburg, 63739

  • Novartis Investigative Site

    Bad Wörishofen, 86825

  • Novartis Investigative Site

    Bamberg, 96049

  • Novartis Investigative Site

    Berlin, Germany, 10117

  • Novartis Investigative Site

    Berlin, Germany, 10969

  • Novartis Investigative Site

    Berlin, Germany, 12099

  • Novartis Investigative Site

    Berlin, State of Berlin, 10117

  • Novartis Investigative Site

    Berlin, State of Berlin, 10119

  • Novartis Investigative Site

    Berlin, 10367

  • Novartis Investigative Site

    Berlin, 10789

  • Novartis Investigative Site

    Berlin, 12043

  • Novartis Investigative Site

    Berlin, 12203

  • Novartis Investigative Site

    Berlin, 13086

  • Novartis Investigative Site

    Berlin, 13156

  • Novartis Investigative Site

    Berlin, 13581

  • Novartis Investigative Site

    Bielefeld, 33617

  • Novartis Investigative Site

    Bochum, 44787

  • Novartis Investigative Site

    Bonn, 53119

  • Novartis Investigative Site

    Bonn, 53123

  • Novartis Investigative Site

    Cologne, 51069

  • Novartis Investigative Site

    Cottbus, Saxony, 03050

  • Novartis Investigative Site

    Delitzsch, 04509

  • Novartis Investigative Site

    Dresden, Germany, 01307

  • Novartis Investigative Site

    Duisburg, 47057

  • Novartis Investigative Site

    Erlangen, 91052

  • Novartis Investigative Site

    Frankfurt, 60389

  • Novartis Investigative Site

    Frankfurt, 60596

  • Novartis Investigative Site

    Freudenberg, 57258

  • Novartis Investigative Site

    Gauting, 82131

  • Novartis Investigative Site

    Geesthacht, Schleswig-Holstein, 12502

  • Novartis Investigative Site

    Hagen, 59065

  • Novartis Investigative Site

    Halle, 06108

  • Novartis Investigative Site

    Hamburg, 20253

  • Novartis Investigative Site

    Hamburg, 20354

  • Novartis Investigative Site

    Hamburg, 22299

  • Novartis Investigative Site

    Hannover Münden, 34346

  • Novartis Investigative Site

    Hanover, Lower Saxony, 30159

  • Novartis Investigative Site

    Heidelberg, Baden-Wurttemberg, 69126

  • Novartis Investigative Site

    Kassel, 34121

  • Novartis Investigative Site

    Koblenz, North Rhine-Westphalia, 56068

  • Novartis Investigative Site

    Landsberg, 86899

  • Novartis Investigative Site

    Leipzig, Germany, 04207

  • Novartis Investigative Site

    Leipzig, 04103

  • Novartis Investigative Site

    Leipzig, 04275

  • Novartis Investigative Site

    Leipzig, 04357

  • Novartis Investigative Site

    Lübeck, 23552

  • Novartis Investigative Site

    Lübeck, 23558

  • Novartis Investigative Site

    Marburg, Germany, 35037

  • Novartis Investigative Site

    Minden, 32423

  • Novartis Investigative Site

    München, 80335

  • Novartis Investigative Site

    Neu-Isenburg, 63263

  • Novartis Investigative Site

    Neumünster, 24534

  • Novartis Investigative Site

    Oranienburg, 16515

  • Novartis Investigative Site

    Peine, Lower Saxony, 31224

  • Novartis Investigative Site

    Potsdam, Germany, 14467

  • Novartis Investigative Site

    Potsdam, 14469

  • Novartis Investigative Site

    Prien A. Chiemsee, 83209

  • Novartis Investigative Site

    Ratingen, 40878

  • Novartis Investigative Site

    Reinfeld, 23858

  • Novartis Investigative Site

    Rüdersdorf, 15562

  • Novartis Investigative Site

    Schleswig, 24837

  • Novartis Investigative Site

    Schwabach, 91126

  • Novartis Investigative Site

    Solingen, 42651

  • Novartis Investigative Site

    Stade, 21680

  • Novartis Investigative Site

    Teuchern, 06682

  • Novartis Investigative Site

    Ulm, 89073

  • Novartis Investigative Site

    Warendorf, 48231

  • Novartis Investigative Site

    Weinheim, 69469

  • Novartis Investigative Site

    Wissen, 57537

  • Novartis Investigative Site

    Witten, 58452

Other trials in Germany

Japan29 sites

  • Novartis Investigative Site

    Asahikawa, Hokkaido, 070-8644

  • Novartis Investigative Site

    Bunkyo-ku, Tokyo, 113-8431

  • Novartis Investigative Site

    Chuo-ku, Tokyo, 103-0027

  • Novartis Investigative Site

    Fukuoka, Fukuoka, 811-1394

  • Novartis Investigative Site

    Fukuoka, Fukuoka, 812-0033

  • Novartis Investigative Site

    Hamamatsu, Shizuoka, 430-8525

  • Novartis Investigative Site

    Hamamatsu, Shizuoka, 434-8511

  • Novartis Investigative Site

    Himeji, Hyōgo, 672-8064

  • Novartis Investigative Site

    Itabashi-ku, Tokyo, 173-8610

  • Novartis Investigative Site

    Iwata, Shizuoka, 438-8550

  • Novartis Investigative Site

    Kawasaki, Kanagawa, 210-0852

  • Novartis Investigative Site

    Kishiwada, Osaka, 596-8501

  • Novartis Investigative Site

    Kiyose, Tokyo, 204-8585

  • Novartis Investigative Site

    Kochi, Kochi, 780-8077

  • Novartis Investigative Site

    Komaki, Aichi-ken, 485-0041

  • Novartis Investigative Site

    Kōshi, Kumamoto, 861-1196

  • Novartis Investigative Site

    Koshigaya, Saitama, 343-0851

  • Novartis Investigative Site

    Kyoto, Kyoto, 606-8507

  • Novartis Investigative Site

    Matsusaka, Mie-ken, 515-8544

  • Novartis Investigative Site

    Meguro City, Tokyo, 152-8902

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 457-8511

  • Novartis Investigative Site

    Sakaidechō, Kagawa-ken, 762-8550

  • Novartis Investigative Site

    Sapporo, Hokkaido, 060-8648

  • Novartis Investigative Site

    Sapporo, Hokkaido, 062-8618

  • Novartis Investigative Site

    Sendai, Miyagi, 980-8574

  • Novartis Investigative Site

    Seto, Aichi-ken, 489-8642

  • Novartis Investigative Site

    Takamatsu, Kagawa-ken, 760-8538

  • Novartis Investigative Site

    Toyoake, Aichi-ken, 470-1192

  • Novartis Investigative Site

    Yanagawa, Fukuoka, 832-0059

Other trials in Japan

Argentina25 sites

  • Novartis Investigative Site

    Buenos Aires, Buenos Aires, 1425

  • Novartis Investigative Site

    Buenos Aires, Buenos Aires, C1120AAC

  • Novartis Investigative Site

    Buenos Aires, Buenos Aires F.D., C1028AAP

  • Novartis Investigative Site

    Caba, Buenos Aires, 1122

  • Novartis Investigative Site

    Caba, Buenos Aires, C1056ABJ

  • Novartis Investigative Site

    Caba, Buenos Aires, C1122AAK

  • Novartis Investigative Site

    Caba, Buenos Aires, C1414AIF

  • Novartis Investigative Site

    Caba, Buenos Aires, C1424BSF

  • Novartis Investigative Site

    Caba, Buenos Aires, C1425BEA

  • Novartis Investigative Site

    Caba, Buenos Aires, C1425BEN

  • Novartis Investigative Site

    Caba, Buenos Aires, C1426ABP

  • Novartis Investigative Site

    Ciudad de Buenos Aires, Argentina, C1425AUA

  • 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

    Mar del Plata, Buenos Aires, B7600

  • Novartis Investigative Site

    Mendoza, Mendoza Province, 5500

  • Novartis Investigative Site

    Mendoza, Mendoza Province, M5500CBA

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2000AII

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2000DBS

  • Novartis Investigative Site

    Salta, Salta Province, 4000

  • Novartis Investigative Site

    San Miguel de Tucumán, Tucumán Province, 4000

  • Novartis Investigative Site

    San Miguel de Tucumán, Tucumán Province, T4000IFL

  • Novartis Investigative Site

    Santa Fe, Santa Fe Province, S3000FIL

Other trials in Argentina

Spain23 sites

  • Novartis Investigative Site

    Alicante, Valencia, 03550

  • Novartis Investigative Site

    Alzira, Valencia, 46600

  • Novartis Investigative Site

    Barakaldo, Vizcaya, 48903

  • Novartis Investigative Site

    Barcelona, Barcelona, 08022

  • Novartis Investigative Site

    Barcelona, Catalonia, 08003

  • Novartis Investigative Site

    Barcelona, Catalonia, 08024

  • Novartis Investigative Site

    Barcelona, Catalonia, 08026

  • Novartis Investigative Site

    Barcelona, Catalonia, 08035

  • Novartis Investigative Site

    Burgos, Castille and León, 09006

  • Novartis Investigative Site

    Cartagena, Murcia, 30202

  • Novartis Investigative Site

    Córdoba, Andalusia, 14004

  • Novartis Investigative Site

    Madrid, Madrid, 28029

  • Novartis Investigative Site

    Madrid, Madrid, 28046

  • Novartis Investigative Site

    Málaga, Andalusia, 29010

  • Novartis Investigative Site

    Mérida, Extremadura, 06800

  • Novartis Investigative Site

    Oviedo, Principality of Asturias, 33006

  • Novartis Investigative Site

    Ponferrada, Castille and León, 24400

  • Novartis Investigative Site

    Pozuelo de Alarcón, Madrid, 28223

  • Novartis Investigative Site

    Salt, Catalonia, 17190

  • Novartis Investigative Site

    Sanlúcar de Barrameda, Andalusia, 11540

  • Novartis Investigative Site

    Torrelavega, Cantabria, 39300

  • Novartis Investigative Site

    Valencia, Valencia, 46014

  • Novartis Investigative Site

    Valladolid, Castille and León, 47011

Other trials in Spain

China20 sites

  • Novartis Investigative Site

    Beijing, Beijing Municipality, 100023

  • Novartis Investigative Site

    Beijing, Beijing Municipality, 100730

  • Novartis Investigative Site

    Beijing, 100050

  • Novartis Investigative Site

    Changsha, Hunan, 410003

  • Novartis Investigative Site

    Chengdu, Sichuan, 610041

  • Novartis Investigative Site

    Chongqing, 400037

  • Novartis Investigative Site

    Chongqing, 400038

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510120

  • Novartis Investigative Site

    Guangzhou, 510010

  • Novartis Investigative Site

    Haikou, Hainan, 570311

  • Novartis Investigative Site

    Hangzhou, Zhejiang, 310006

  • Novartis Investigative Site

    Nanchang, Jiangxi, 330006

  • Novartis Investigative Site

    Nanjing, Jiangsu, 210029

  • Novartis Investigative Site

    Shanghai, Shanghai Municipality, 200433

  • Novartis Investigative Site

    Shanghai, 200025

  • Novartis Investigative Site

    Shengyang, Liaoning, 110016

  • Novartis Investigative Site

    Shijiazhuang, Hebei, 050000

  • Novartis Investigative Site

    Suzhou, Jiangsu, 215006

  • Novartis Investigative Site

    Tianjin, 300052

  • Novartis Investigative Site

    Xi’an, Shanxi, 710032

Other trials in China

United Kingdom19 sites

  • Novartis Investigative Site

    Axbridge, Somerset, BS26 2BJ

  • Novartis Investigative Site

    Birmingham, B15 2TH

  • Novartis Investigative Site

    Bradford, West Yorkshire, BD9 6RJ

  • Novartis Investigative Site

    Cambridge, United KIngdom, CB7 5JD

  • Novartis Investigative Site

    Chester, CH2 1UL

  • Novartis Investigative Site

    Crawley, West Sussex, RH10 7DX

  • Novartis Investigative Site

    Darlington, DL3 6HX

  • Novartis Investigative Site

    Huntingdon, Cambridgeshire, PE29 6NT

  • Novartis Investigative Site

    Lancashire, FY3 7EN

  • Novartis Investigative Site

    Leeds, LS9 7TF

  • Novartis Investigative Site

    London, EC14 7BE

  • Novartis Investigative Site

    Midsomer Norton, Radstock, BA3 2UH

  • Novartis Investigative Site

    Newcastle upon Tyne, NE7 7DN

  • Novartis Investigative Site

    South Shields, Tyne and Wear, NE34 0PL

  • Novartis Investigative Site

    Southampton, SO16 6YD

  • Novartis Investigative Site

    Stockton, Cleveland, TS19 8PE

  • Novartis Investigative Site

    Taunton, Somerset, TA1 5DA

  • Novartis Investigative Site

    Tyne & Wear, NE29 8NH

  • Novartis Investigative Site

    Wiltshire, SN15 2SB

Other trials in United Kingdom

Belgium18 sites

  • Novartis Investigative Site

    Aalst, 9300

  • Novartis Investigative Site

    Brussels, 1000

  • Novartis Investigative Site

    Brussels, 1070

  • Novartis Investigative Site

    Brussels, 1090

  • Novartis Investigative Site

    Brussels, 1200

  • Novartis Investigative Site

    Erpent, 5101

  • Novartis Investigative Site

    Genk, Limburg, 3600

  • Novartis Investigative Site

    Ghent, 9000

  • Novartis Investigative Site

    Gilly, 6060

  • Novartis Investigative Site

    Gosselies, BEL, 6041

  • Novartis Investigative Site

    Hasselt, 3500

  • Novartis Investigative Site

    Leuven, 3000

  • Novartis Investigative Site

    Liège, 4000

  • Novartis Investigative Site

    Luxembourg, Luxembourg, 1210

  • Novartis Investigative Site

    Ostend, 8400

  • Novartis Investigative Site

    Roeselare, 8800

  • Novartis Investigative Site

    Turnhout, 2300

  • Novartis Investigative Site

    Wavre, 1301

Other trials in Belgium

Czechia18 sites

  • Novartis Investigative Site

    Benešov, 256 30

  • Novartis Investigative Site

    Český Krumlov, Czech Republic, 381 01

  • Novartis Investigative Site

    Cvikov, Czech Republic, 471 54

  • Novartis Investigative Site

    Jindrichuv Hradec III, Czech Republic, 377 01

  • Novartis Investigative Site

    Liberec, Czech Republic, 460 01

  • Novartis Investigative Site

    Mělník, Czech Republic, 267 01

  • Novartis Investigative Site

    Olomouc, 775 20

  • Novartis Investigative Site

    Ostrava, Czech Republic, 708 68

  • Novartis Investigative Site

    Ostrava - Hrabuvka, Czech Republic, 70030

  • Novartis Investigative Site

    Pardubice, Czech Republic, 530 09

  • Novartis Investigative Site

    Prague, Czech Republic, 108 00

  • Novartis Investigative Site

    Prague, Czech Republic, 142 00

  • Novartis Investigative Site

    Prague, Czech Republic, 158 00

  • Novartis Investigative Site

    Prague, Czech Republic, 169 00

  • Novartis Investigative Site

    Praha 6 - Repy, Czech Republic, 163 00

  • Novartis Investigative Site

    Strakonice, Czech Republic, 38601

  • Novartis Investigative Site

    Teplice, Czech Republic, 415 01

  • Novartis Investigative Site

    Žatec, Czech Republic, 438 01

Other trials in Czechia

Italy18 sites

  • Novartis Investigative Site

    Ancona, AN, 60020

  • Novartis Investigative Site

    Cassano delle Murge, BA, 70020

  • Novartis Investigative Site

    Cittadella, PD, 35013

  • Novartis Investigative Site

    Crema, CR, 26013

  • Novartis Investigative Site

    Cuasso al Monte, VA, 21050

  • Novartis Investigative Site

    Florence, FI, 50100

  • Novartis Investigative Site

    Foggia, FG, 71100

  • Novartis Investigative Site

    Genova, GE, 16132

  • Novartis Investigative Site

    Milan, MI, 20126

  • Novartis Investigative Site

    Naples, 80131

  • Novartis Investigative Site

    Negrar, VR, 37024

  • Novartis Investigative Site

    Palermo, PA, 90146

  • Novartis Investigative Site

    Pavia, PV, 27100

  • Novartis Investigative Site

    Pavullo nel Frignano, MO, 41026

  • Novartis Investigative Site

    Pisa, PI, 56124

  • Novartis Investigative Site

    Pordenone, PN, 33170

  • Novartis Investigative Site

    Reggio Emilia, RE, 42123

  • Novartis Investigative Site

    Tradate, VA, 21049

Other trials in Italy

Romania18 sites

  • Novartis Investigative Site

    Arad, 310013

  • Novartis Investigative Site

    Arad, 310086

  • Novartis Investigative Site

    Brasov, Romania, 500086

  • Novartis Investigative Site

    Bucharest, District 1, 10457

  • Novartis Investigative Site

    Bucharest, District 3, 030317

  • Novartis Investigative Site

    Bucharest, Romania

  • Novartis Investigative Site

    Bucharest, 050159

  • Novartis Investigative Site

    Bucharest, 060011

  • Novartis Investigative Site

    Bucharest, 50159

  • Novartis Investigative Site

    Cluj-Napoca, 400371

  • Novartis Investigative Site

    Craiova, Dolj, 200515

  • Novartis Investigative Site

    Deva, Romania, 330084

  • Novartis Investigative Site

    Deva, 330162

  • Novartis Investigative Site

    Iași, Jud. Iasi, 700115

  • Novartis Investigative Site

    Iași, Romania, 700305

  • Novartis Investigative Site

    Oradea, Romania, 410051

  • Novartis Investigative Site

    Târgu Mureş, Romania, 540072

  • Novartis Investigative Site

    Timișoara, Timiș County, 300310

Other trials in Romania

India16 sites

  • Novartis Investigative Site

    Ahmedabad, Gujarat, 380 008

  • Novartis Investigative Site

    Ahmedabad, Gujarat, 380 060

  • Novartis Investigative Site

    Bangalore, 560 034

  • Novartis Investigative Site

    Chennai, Tamil Nadu, 641037

  • Novartis Investigative Site

    Coimbatore, Tamil Nadu, 641 018

  • Novartis Investigative Site

    Coimbatore, Tamil Nadu, 641 045.

  • Novartis Investigative Site

    Coimbatore, Tamil Nadu, 641037

  • Novartis Investigative Site

    Gurgaon, Haryana, 122 002

  • Novartis Investigative Site

    Hyderabad, Andhra Pradesh, 500004

  • Novartis Investigative Site

    Kolkata, West Bengal, 700 107

  • Novartis Investigative Site

    Ludhiana, Punjab, 141001

  • Novartis Investigative Site

    Manipal, Karnataka, 576 104

  • Novartis Investigative Site

    Nagpur, Maharashtra, 400 012

  • Novartis Investigative Site

    Nagpur, Maharashtra, 440010

  • Novartis Investigative Site

    Vijayawada, Andhra Pradesh, 520 002

  • Novartis Investigative Site

    Visakhapatnam, Andhra Pradesh, 530002

Other trials in India

Slovakia16 sites

  • Novartis Investigative Site

    Bardejov, Slovak Republic, 085 01

  • Novartis Investigative Site

    Bojnice, Slovak Republic, 972 01

  • Novartis Investigative Site

    Bratislava, Slovakia, 84104

  • Novartis Investigative Site

    Humenné, Slovak Republic, 066 01

  • Novartis Investigative Site

    Košice, Slovak Republic, 04001

  • Novartis Investigative Site

    Košice, Slovakia, 040 01

  • Novartis Investigative Site

    Košice, 040 01

  • Novartis Investigative Site

    Liptovský Hrádok, Slovak Republic, 033 01

  • Novartis Investigative Site

    Lučenec, Slovakia, 98439

  • Novartis Investigative Site

    Martin, Slovakia, 036 59

  • Novartis Investigative Site

    Námestovo, Slovensko, 02901

  • Novartis Investigative Site

    Nové Zámky, 940 01

  • Novartis Investigative Site

    Partizánske, Slovak Republic, 958 01

  • Novartis Investigative Site

    Poprad, 058 01

  • Novartis Investigative Site

    Považská Bystrica, Slovakia, 017 01

  • Novartis Investigative Site

    Spisská Nová Ves, 052 01

Other trials in Slovakia

Canada12 sites

  • Novartis Investigative Site

    Burlington, Ontario, L7N 3V2

  • Novartis Investigative Site

    Calgary, Alberta, T2N 4n1

  • Novartis Investigative Site

    Downsview, Ontario, M3N 2Z9

  • Novartis Investigative Site

    Mirabel, Quebec, J7J 2K8

  • Novartis Investigative Site

    Moncton, New Brunswick, E1G 1A7

  • Novartis Investigative Site

    Montreal, Quebec, H1M 1B1

  • Novartis Investigative Site

    Montreal, Quebec, H3G 1L5

  • Novartis Investigative Site

    Québec, Quebec, G1N 4V3

  • Novartis Investigative Site

    Saint-Charles-Borromée, Quebec, J6E 2B4

  • Novartis Investigative Site

    Sherbrooke, Quebec, J1H 5N4

  • Novartis Investigative Site

    Toronto, Ontario, M5T 3A9

  • Novartis Investigative Site

    Vancouver, British Columbia, V5Z 4E1

Other trials in Canada

France12 sites

  • Novartis Investigative Site

    Angers, 49000

  • Novartis Investigative Site

    Beuvry, France, 62660

  • Novartis Investigative Site

    Briis-sous-Forges, 91640

  • Novartis Investigative Site

    Cournonterral, 34660

  • Novartis Investigative Site

    Lyon, 69317

  • Novartis Investigative Site

    Montpellier, 34059

  • Novartis Investigative Site

    Nantes, 44000

  • Novartis Investigative Site

    Nantes, 44300

  • Novartis Investigative Site

    Nîmes, 30029

  • Novartis Investigative Site

    Pessac, 33604

  • Novartis Investigative Site

    Reims, 51092

  • Novartis Investigative Site

    Saint-Génis-des-Fontaines, 66740

Other trials in France

Portugal11 sites

  • Novartis Investigative Site

    Almada, Portugal, 2801-951

  • Novartis Investigative Site

    Barcelos, Portugal, 4754-909

  • Novartis Investigative Site

    Braga, Portugal, 4710-243

  • Novartis Investigative Site

    Coimbra, Portugal, 3041-853

  • Novartis Investigative Site

    Lisbon, Lisbon District, 1769-001

  • Novartis Investigative Site

    Lisbon, Portugal, 1169-024

  • Novartis Investigative Site

    Porto, Portugal, 4200-319

  • Novartis Investigative Site

    Torres Vedras, Portugal, 2560-324

  • Novartis Investigative Site

    Vila Franca de Xira, Portugal, 2600-009

  • Novartis Investigative Site

    Vila Nova de Gaia, Portugal, 4434-502

  • Novartis Investigative Site

    Viseu, Portugal, 3504-509

Other trials in Portugal

Austria10 sites

  • Novartis Investigative Site

    Feldbach, Austria, 8330

  • Novartis Investigative Site

    Feldkirch, Austria, 6800

  • Novartis Investigative Site

    Graz, Austria, A-8036

  • Novartis Investigative Site

    Grieskirchen, Austria, 4710

  • Novartis Investigative Site

    Innsbruck, Tyrol, 6020

  • Novartis Investigative Site

    Linz, Austria, 4020

  • Novartis Investigative Site

    Salzburg, 5020

  • Novartis Investigative Site

    Thalheim bei Wels, Austria, 4600

  • Novartis Investigative Site

    Vienna, A-1230

  • Novartis Investigative Site

    Wels, Austria, 4600

Other trials in Austria

Greece10 sites

  • Novartis Investigative Site

    Athens, Greece, 12462

  • Novartis Investigative Site

    Athens, GR, 106 76

  • Novartis Investigative Site

    Athens, GR, 115 27

  • Novartis Investigative Site

    Athens, GR 115 27

  • Novartis Investigative Site

    Heraklion Crete, GR 711 10

  • Novartis Investigative Site

    Larissa, GR, 411 10

  • Novartis Investigative Site

    Rethymno, GR, 741 00

  • Novartis Investigative Site

    Serres, Greece, GR 62 100

  • Novartis Investigative Site

    Thessaloniki, GR, 564 03

  • Novartis Investigative Site

    Thessaloniki, GR 570 10

Other trials in Greece

Russia10 sites

  • Novartis Investigative Site

    Barnaul, 656045

  • Novartis Investigative Site

    Chelyabinsk, 454021

  • Novartis Investigative Site

    Kazan', 420012

  • Novartis Investigative Site

    N.Novgorod, 603126

  • Novartis Investigative Site

    Rostov-on-Don, 344090

  • Novartis Investigative Site

    Ryazan, 390026

  • Novartis Investigative Site

    Saratov, 410012

  • Novartis Investigative Site

    Tver', 170100

  • Novartis Investigative Site

    Ufa, 450000

  • Novartis Investigative Site

    Yaroslavl, 150030

Other trials in Russia

South Africa10 sites

  • Novartis Investigative Site

    Berea, Durban, 4001

  • Novartis Investigative Site

    Cape Town, 7500

  • Novartis Investigative Site

    Cape Town, 7505

  • Novartis Investigative Site

    Cape Town, 7531

  • Novartis Investigative Site

    Cape Town, 7925

  • Novartis Investigative Site

    Gatesville, 7764

  • Novartis Investigative Site

    Port Elizabeth, 6014

  • Novartis Investigative Site

    Pretoria, South Africa, 0132

  • Novartis Investigative Site

    Pretoria, 0181

  • Novartis Investigative Site

    Sandton, Gauteng, 2057

Other trials in South Africa

Bulgaria9 sites

  • Novartis Investigative Site

    Gabrovo, 5300

  • Novartis Investigative Site

    Pleven, 5800

  • Novartis Investigative Site

    Plovdiv, 4002

  • Novartis Investigative Site

    Rousse, Bulgaria, 7002

  • Novartis Investigative Site

    Sofia, Bulgaria, 1431

  • Novartis Investigative Site

    Sofia, 1431

  • Novartis Investigative Site

    Stara Zagora, 6000

  • Novartis Investigative Site

    Troyan Municipality, 5600

  • Novartis Investigative Site

    Varna, Bulgaria, 9020

Other trials in Bulgaria

Denmark9 sites

  • Novartis Investigative Site

    Aalborg, Denmark, DK-9000

  • Novartis Investigative Site

    Aarhus, DK-8000

  • Novartis Investigative Site

    Copenhagen NV, DK-2400

  • Novartis Investigative Site

    Hellerup, Denmark, DK-2900

  • Novartis Investigative Site

    Hvidovre, Denmark, DK-2650

  • Novartis Investigative Site

    Næstved, 4700

  • Novartis Investigative Site

    Roskilde, Denmark, DK-4000

  • Novartis Investigative Site

    Silkeborg, Denmark, 8600

  • Novartis Investigative Site

    Sønderborg, Denmark, DK-6400

Other trials in Denmark

Lithuania9 sites

  • Novartis Investigative Site

    Alytus, LT-62114

  • Novartis Investigative Site

    Kaunas, LTU, 50009

  • Novartis Investigative Site

    Kaunas, LT, 50128

  • Novartis Investigative Site

    Kaunas, LT-45130

  • Novartis Investigative Site

    Klaipėda, 92288

  • Novartis Investigative Site

    Klaipėda, LT-92231

  • Novartis Investigative Site

    Vilnius, LT, 01117

  • Novartis Investigative Site

    Vilnius, 06122

  • Novartis Investigative Site

    Vilnius, LT-08661

Other trials in Lithuania

Netherlands9 sites

  • Novartis Investigative Site

    Almelo, Netherlands, 7609 PP

  • Novartis Investigative Site

    Assen, 9401 RK

  • Novartis Investigative Site

    Breda, 4818 CK

  • Novartis Investigative Site

    Eindhoven, 5623 EJ

  • Novartis Investigative Site

    Enschede, Netherlands, 7513 ER

  • Novartis Investigative Site

    Geldrop, 5664 EH

  • Novartis Investigative Site

    Groningen, 9728 NT

  • Novartis Investigative Site

    Harderwijk, Netherlands, 3840 AC

  • Novartis Investigative Site

    Zutphen, Netherlands, 7207 AE

Other trials in Netherlands

South Korea9 sites

  • Novartis Investigative Site

    Bucheon-si, Gyeonggi-do, 14584

  • Novartis Investigative Site

    Incheon, 403-720

  • Novartis Investigative Site

    Jeonju, Jeollabuk-do, 561-712

  • Novartis Investigative Site

    Seoul, Korea, 03080

  • Novartis Investigative Site

    Seoul, Korea, 130-709

  • Novartis Investigative Site

    Seoul, Korea, 137-701

  • Novartis Investigative Site

    Seoul, Seoul, 156-755

  • Novartis Investigative Site

    Seoul, 130-872

  • Novartis Investigative Site

    Seoul, 136-705

Other trials in South Korea

Norway8 sites

  • Novartis Investigative Site

    Follebu, 2656

  • Novartis Investigative Site

    Hønefoss, 3515

  • Novartis Investigative Site

    Kløfta, 2040

  • Novartis Investigative Site

    Kongsvinger, 2212

  • Novartis Investigative Site

    Skedsmokorset, 2020

  • Novartis Investigative Site

    Stavanger, 4005

  • Novartis Investigative Site

    Svelvik, 3060

  • Novartis Investigative Site

    Trondheim, 7006

Other trials in Norway

Taiwan8 sites

  • Novartis Investigative Site

    Chiayi County, 613

  • Novartis Investigative Site

    Niaosong Township, 83301

  • Novartis Investigative Site

    Taichung, Taiwan, 40705

  • Novartis Investigative Site

    Taichung, 40447

  • Novartis Investigative Site

    Tainan, Taiwan ROC

  • Novartis Investigative Site

    Taipei, 10002

  • Novartis Investigative Site

    Taipei, 112

  • Novartis Investigative Site

    Taipei County, Taiwan, 22060

Other trials in Taiwan

Turkey (Türkiye)8 sites

  • Novartis Investigative Site

    Ankara, Turkey, 06100

  • Novartis Investigative Site

    Ankara, Turkey, 06490

  • Novartis Investigative Site

    Istanbul, 34854

  • Novartis Investigative Site

    Istanbul

  • Novartis Investigative Site

    Izmir, Turkey, 35040

  • Novartis Investigative Site

    Kinikli / Denizli, 20070

  • Novartis Investigative Site

    Manisa, 45040

  • Novartis Investigative Site

    Mersin, 33079

Other trials in Turkey (Türkiye)

Mexico7 sites

  • Novartis Investigative Site

    Aguascalientes, Aguascalientes, 20230

  • Novartis Investigative Site

    Guadalajara Jalisco, Jalisco, 44220

  • Novartis Investigative Site

    Mexico City, Mexico City, 14050

  • Novartis Investigative Site

    Mexico City, Mexico City, 14080

  • Novartis Investigative Site

    Mexico City, 06726

  • Novartis Investigative Site

    Puebla City, Puebla, 72000

  • Novartis Investigative Site

    Zapopan, Jalisco, 45200

Other trials in Mexico

Poland7 sites

  • Novartis Investigative Site

    Bialystok, 15-010

  • Novartis Investigative Site

    Bialystok, 15-044

  • Novartis Investigative Site

    Lodz, 90-153

  • Novartis Investigative Site

    Piła, 64-920

  • Novartis Investigative Site

    Poznan, 60-569

  • Novartis Investigative Site

    Sopot, 81-741

  • Novartis Investigative Site

    Wroclaw, 51-162

Other trials in Poland

Finland6 sites

  • Novartis Investigative Site

    Helsinki, 00290

  • Novartis Investigative Site

    HUS, 00029

  • Novartis Investigative Site

    Jyväskylä, 40100

  • Novartis Investigative Site

    Kuopio, FIN-70211

  • Novartis Investigative Site

    Pori, FIN-28500

  • Novartis Investigative Site

    Turku, Finland, FIN-20100

Other trials in Finland

Hungary6 sites

  • Novartis Investigative Site

    Budapest, 1121

  • Novartis Investigative Site

    Budapest, 1125

  • Novartis Investigative Site

    Budapest, 1145

  • Novartis Investigative Site

    Deszk, 6772

  • Novartis Investigative Site

    Komárom, Hungary, 2900

  • Novartis Investigative Site

    Törökbálint, 2045

Other trials in Hungary

Sweden6 sites

  • Novartis Investigative Site

    Borås, 506 30

  • Novartis Investigative Site

    Luleå, SE-971 80

  • Novartis Investigative Site

    Lund, SE-221 85

  • Novartis Investigative Site

    Stockholm, 111 57

  • Novartis Investigative Site

    Trollhättan, 461 85

  • Novartis Investigative Site

    Uddevalla, 451 50

Other trials in Sweden

Colombia4 sites

  • Novartis Investigative Site

    Armenia

  • Novartis Investigative Site

    Bogota, Cundinamarca

  • Novartis Investigative Site

    Floridablanca, Santander Department, 57-7

  • Novartis Investigative Site

    Medellín

Other trials in Colombia

Serbia4 sites

  • Novartis Investigative Site

    Belgrade, Serbia, 11000

  • Novartis Investigative Site

    Belgrade, Serbia, 11080

  • Novartis Investigative Site

    Knez-Selo, 18204

  • Novartis Investigative Site

    Kragujevac, 34000

Other trials in Serbia

Thailand4 sites

  • Novartis Investigative Site

    Bangkok, 10700

  • Novartis Investigative Site

    Chiang Mai, 50200

  • Novartis Investigative Site

    Khon Kaen, 40002

  • Novartis Investigative Site

    Songkhla, 90110

Other trials in Thailand

Chile3 sites

  • Novartis Investigative Site

    Quillota, 2260877

  • Novartis Investigative Site

    Santiago, Santiago Metropolitan

  • Novartis Investigative Site

    Santiago, 8910131

Other trials in Chile

Croatia3 sites

  • Novartis Investigative Site

    Karlovac, 47000

  • Novartis Investigative Site

    Zagreb, Croatia, 10 000

  • Novartis Investigative Site

    Zagreb, 10000

Other trials in Croatia

Estonia3 sites

  • Novartis Investigative Site

    Tallinn, 13419

  • Novartis Investigative Site

    Tallinn, 13619

  • Novartis Investigative Site

    Tartu, Estonia, 51014

Other trials in Estonia

Guatemala3 sites

  • Novartis Investigative Site

    Ciudad, Gautemala, 01010

  • Novartis Investigative Site

    Guatemala City, Departamento de Guatemala, 01010

  • Novartis Investigative Site

    Guatemala City, Departamento de Guatemala, 01011

Other trials in Guatemala

Latvia3 sites

  • Novartis Investigative Site

    Daugavpils, LV-5401

  • Novartis Investigative Site

    Riga, LV, LV-1038

  • Novartis Investigative Site

    Riga, 1002

Other trials in Latvia

Philippines3 sites

  • Novartis Investigative Site

    Bulacan, Philippines, 3020

  • Novartis Investigative Site

    Lipa City, Batangas, 4217

  • Novartis Investigative Site

    Quezon City, 1100

Other trials in Philippines

Hong Kong2 sites

  • Novartis Investigative Site

    Kowloon, Hong Kong

  • Novartis Investigative Site

    New Territories, Hong Kong

Other trials in Hong Kong

Iceland1 site

  • Novartis Investigative Site

    Reykjavik, IS-109

Other trials in Iceland

About this study

Official title: A 52-week Treatment, Multi-center, Randomized, Double-blind, Double Dummy, Parallel-group, Active Controlled Study to Compare the Effect of QVA149 (Indacaterol Maleate / Glycopyrronium Bromide) With Salmeterol/Fluticasone on the Rate of Exacerbations in Subjects With Moderate to Very Severe COPD. (FLAME).

This study will assess the efficacy, safety and tolerability of QVA149 in patients with moderate to very severe COPD.

Being tested
QVA149, Long acting B2 agonist (LABA) and inhaled corticosteroid (ICS)
Keywords
COPD, QVA149, FLAME( EFfect of Indacaterol Glycopyronium Vs Fluticasone salmeterol on COPD Exacerbations)
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.

  • Long acting B2 agonist (LABA) and inhaled corticosteroid (ICS)Drug

    Salmeterol/fluticasone dry inhalation powder delivered via the Accuhaler device.

Study groups in NCT01782326
Study groupRoleWhat they receive
QVA149ExperimentalQVA149 (110/50 μg) once daily
Receives: Drug: QVA149
Long acting B2 agonist (LABA) and inhaled corticosteroid (ICS)Active comparatorSalmeterol/fluticasone (50/500μg) b.i.d
Receives: Drug: Long acting B2 agonist (LABA) and inhaled corticosteroid (ICS)

What is being measured

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

  1. Rate of COPD Exacerbations

    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. Estimates are from a generalized linear model assuming a negative binomial distribution with terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. As the offset variable log(exposure time in years) was used.

    Measured: 52 weeks

Secondary outcomes (27)

  1. Time to First COPD Exacerbation.

    First COPD exacerbations starting between first dose and one day after last treatment are included. Cox regression model includes terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region.

    Measured: 52 weeks

  2. Rate of Moderate to Severe COPD Exacerbations.

    COPD exacerbations starting between date of 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 with the worst severity. A COPD exacerbation of moderate severity meets the symptoms definition in the protocol and requires treatment with systemic corticosteroids and/or antibiotics. A severe COPD exacerbation requires hospitalization. Estimates are from a generalized linear model assuming a negative binomial distribution with terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. The offset variable log(exposure time in years) was used.

    Measured: 52 weeks

  3. Time to First Moderate to Severe COPD Exacerbation.

    First COPD exacerbations starting between first dose and one day after last treatment are included. Cox regression model includes terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region.

    Measured: 52 weeks.

  4. Rate of Moderate to Severe COPD Exacerbations Requiring Treatment With Systemic Corticosteroids

    COPD exacerbations starting between date of 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 with the worst severity. Estimates are from a generalized linear model assuming a negative binomial distribution with fixed effects of treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. The offset variable log(exposure time in years) was used.

    Measured: 52 weeks

  5. Rate of Moderate to Severe COPD Exacerbations Requiring Treatment With Antibiotics

    Estimates are from a generalized linear model assuming a negative binomial distribution with terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. The offset variable log(exposure time in years) was used. COPD exacerbations starting between first dose and one day after last treatment are included .

    Measured: 52 weeks

  6. Rate of Moderate to Severe COPD Exacerbations Requiring Hospitalization. COPD Exacerbations Starting Between First Dose and One Day After Last Treatment Are Included.

    All exacerbations requiring hospitalization are considered severe according to protocol definitions so this is the rate of severe COPD exacerbations only. Note - an ER visit of longer than 24 hours was considered a hospitalization.

    Measured: 52 weeks

  7. Rate of Moderate to Severe COPD Exacerbations Requiring Re-hospitalization Within 30 Days

    Re-hospitalizations are defined as hospitalizations starting within the first 30 days after a severe COPD exacerbation and between first dose and one day after date of last treatment. Generalized linear model assuming a negative binomial distribution with terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. The offset variable log(exposure time in years) was used. COPD exacerbations starting between first dose and one day after last treatment are included.

    Measured: 52 weeks

  8. Time to First Moderate to Severe COPD Exacerbations Requiring Treatment With Systemic Corticosteroids

    Cox regression model includes terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. COPD exacerbations starting between first dose and one day after date of last treatment are included.

    Measured: 52 weeks

  9. Time to First Moderate to Severe COPD Exacerbations Requiring Treatment With Antibiotics

    Cox regression model includes terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. COPD exacerbations starting between first dose and one day after date of last treatment are included.

    Measured: 52 weeks

  10. Time to First Moderate to Severe COPD Exacerbations Requiring Hospitalization

    Cox regression model includes terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. COPD exacerbations starting between first dose and one day after date of last treatment are included.

    Measured: 52 weeks

  11. Time to First Moderate to Severe COPD Exacerbations Requiring Re-hospitalization Within 30 Days

    Cox regression model includes terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. COPD exacerbations starting between first dose and one day after date of last treatment are included.

    Measured: 52 weeks

  12. Forced Expiratory Volume in 1 Second

    Change from baseline. Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, airflow limitation severity, region, visit, treatment-by-visit interaction, and baseline FEV1-by-visit interaction.

    Measured: Baseline, day 1 (30 min and one hour post dose)

  13. Forced Expiratory Volume in 1 Second

    Change from baseline in trough value. Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, airflow limitation severity, visit, treatment-by-visit interaction, and baseline FEV1-by-visit interaction.

    Measured: Baseline, 4 weeks

  14. Forced Expiratory Volume in 1 Second

    Change from baseline in trough value. Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, airflow limitation severity, visit, treatment-by-visit interaction, and baseline FEV1-by-visit interaction.

    Measured: Baseline, 12 weeks

  15. Forced Expiratory Volume in 1 Second

    Change from baseline in trough value. Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, airflow limitation severity, visit, treatment-by-visit interaction, and baseline FEV1-by-visit interaction.

    Measured: Baseline, 26 weeks

  16. Forced Expiratory Volume in 1 Second

    Change from baseline in trough value. Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, airflow limitation severity, visit, treatment-by-visit interaction, and baseline FEV1-by-visit interaction.

    Measured: Baseline, 38 weeks

  17. Forced Expiratory Volume in 1 Second

    Change from baseline in trough value. Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, airflow limitation severity, visit, treatment-by-visit interaction, and baseline FEV1-by-visit interaction.

    Measured: Baseline, 52 weeks

  18. Change From Baseline in Forced Expiratory Volume in 1 Second AUC (0-12h)

    Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction. The trapezoidal rule was used to calculate FEV1 AUC and then normalized to the length of time"

    Measured: Baseline, 52 weeks

  19. Change From Baseline in Total St. George's Respiratory Questionnaire Score

    The St. George Respiratory Questionnaire C (SGRQ-C) is a disease-specific measure of health status for use in COPD that was used to provide the health status measurements in this study. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline SGRQ-C total score, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, airflow limitation severity, visit, treatment*visit Interaction, baseline SGRQ-C total score*visit + region. lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status. A negative change from baseline indicates improvement.

    Measured: Baseline, 4 weeks

  20. Change From Baseline in Total St. George's Respiratory Questionnaire Score

    The St. George Respiratory Questionnaire C (SGRQ-C) is a disease-specific measure of health status for use in COPD that was used to provide the health status measurements in this study. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline SGRQ-C total score, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, airflow limitation severity, visit, treatment*visit Interaction, baseline SGRQ-C total score*visit + region. lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status. A negative change from baseline indicates improvement.

    Measured: Baseline, 12 weeks

  21. Change From Baseline in Total St. George's Respiratory Questionnaire Score

    The St. George Respiratory Questionnaire C (SGRQ-C) is a disease-specific measure of health status for use in COPD that was used to provide the health status measurements in this study. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline SGRQ-C total score, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, airflow limitation severity, visit, treatment*visit Interaction, baseline SGRQ-C total score*visit + region. lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status. A negative change from baseline indicates improvement.

    Measured: Baseline, 26 weeks

  22. Change From Baseline in Total St. George's Respiratory Questionnaire Score

    The St. George Respiratory Questionnaire C (SGRQ-C) is a disease-specific measure of health status for use in COPD that was used to provide the health status measurements in this study. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline SGRQ-C total score, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, airflow limitation severity, visit, treatment*visit Interaction, baseline SGRQ-C total score*visit + region. lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status. A negative change from baseline indicates improvement.

    Measured: Baseline, 38 weeks

  23. Change From Baseline in Total St. George's Respiratory Questionnaire Score

    The St. George Respiratory Questionnaire C (SGRQ-C) is a disease-specific measure of health status for use in COPD that was used to provide the health status measurements in this study. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline SGRQ-C total score, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, airflow limitation severity, visit, treatment*visit Interaction, baseline SGRQ-C total score*visit + region. lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status. A negative change from baseline indicates improvement.

    Measured: Baseline, 52 weeks

  24. Change From Baseline in the Number of Puffs of Rescue Medication

    A linear mixed model (LMM) was used for this analysis Change from baseline in mean number of puffs. LMM including: treatment, baseline value, smoking status at screening, ICS use at screening, airflow limitation severity, region and random effect of center nested within region.

    Measured: Baseline, 52 weeks

  25. Change From Baseline in the Safety of QVA149 ((110/50 μg o.d.) vs Fluticasone/Salmeterol (500/50μg Bid) in Terms of HPA Axis Function, as Determined by Collection of 24-hour Urine Cortisol.

    Urine cortisol/creatinine ratio

    Measured: Baseline, 52 Weeks

  26. Change From Baseline in Forced Vital Capacity

    Change from baseline in trough value (average of values measured 45 and 15 minutes prior to the morning dose). Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FVC was defined as the average of the pre-dose FVC measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FVC measurements, smoking status at screening, screening inhaled corticosteroid (ICS) use, region, baseline FVC * visit interaction, and visit, treatment * visit interaction

    Measured: 4 Weeks, 12 Weeks, 26 Weeks, 38 Weeks, 52 Weeks

  27. Number of Patients With Adverse Events, Serious Adverse Events, and Death

    The overall rate of adverse events reported from initiation through 30 days post last dose.

    Measured: 52 weeks of treatment + 30 days

Timeline

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

  1. First posted1 Feb 2013 (estimated)
  2. Study startJul 2013
  3. Primary completionSep 2015
  4. Study completionSep 2015

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
3,362 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01782326
Sponsor's protocol ID
CQVA149A2318
Status last verified
May 2016
First submitted
30 Jan 2013
Last updated
16 May 2016
Data monitoring committee
No

Publications

  • Mathioudakis AG, Bate S, Chatzimavridou-Grigoriadou V, Sivapalan P, Jensen JS, Bakerly ND, Vestbo J, Singh D. Disproportionate increase in COPD exacerbation risk for 3 months after discontinuing LAMA or ICS: insights from the FLAME trial. Thorax. 2026 May 14;81(6):533-540. doi: 10.1136/thorax-2025-223282.

    PubMed 41402044

  • Mathioudakis AG, Bate S, Sivapalan P, Jensen JS, Singh D, Vestbo J. Rethinking Blood Eosinophils for Assessing Inhaled Corticosteroids Response in COPD: A Post Hoc Analysis From the FLAME Trial. Chest. 2024 Nov;166(5):987-997. doi: 10.1016/j.chest.2024.06.3790. Epub 2024 Jul 9.

    PubMed 38992490

  • Mackay AJ, Kostikas K, Roche N, Frent SM, Olsson P, Pfister P, Gupta P, Patalano F, Banerji D, Wedzicha JA. Impact of baseline symptoms and health status on COPD exacerbations in the FLAME study. Respir Res. 2020 Apr 22;21(1):93. doi: 10.1186/s12931-020-01354-8.

    PubMed 32321518

  • Wedzicha JA, Singh D, Tsiligianni I, Jenkins C, Fucile S, Fogel R, Shen S, Goyal P, Mezzi K, Kostikas K. Treatment response to indacaterol/glycopyrronium versus salmeterol/fluticasone in exacerbating COPD patients by gender: a post-hoc analysis in the FLAME study. Respir Res. 2019 Jan 8;20(1):4. doi: 10.1186/s12931-019-0972-7.

    PubMed 30621717

  • Frent SM, Chapman KR, Larbig M, Mackay A, Fogel R, Gutzwiller FS, Shen S, Patalano F, Banerji D, Kostikas K, Wedzicha JA. Capturing Exacerbations of Chronic Obstructive Pulmonary Disease with EXACT. A Subanalysis of FLAME. Am J Respir Crit Care Med. 2019 Jan 1;199(1):43-51. doi: 10.1164/rccm.201801-0038OC.

    PubMed 30019939

  • Anzueto AR, Kostikas K, Mezzi K, Shen S, Larbig M, Patalano F, Fogel R, Banerji D, Wedzicha JA. Indacaterol/glycopyrronium versus salmeterol/fluticasone in the prevention of clinically important deterioration in COPD: results from the FLAME study. Respir Res. 2018 Jun 20;19(1):121. doi: 10.1186/s12931-018-0830-z.

    PubMed 29925383

  • Roche N, Chapman KR, Vogelmeier CF, Herth FJF, Thach C, Fogel R, Olsson P, Patalano F, Banerji D, Wedzicha JA. Blood Eosinophils and Response to Maintenance Chronic Obstructive Pulmonary Disease Treatment. Data from the FLAME Trial. Am J Respir Crit Care Med. 2017 May 1;195(9):1189-1197. doi: 10.1164/rccm.201701-0193OC.

    PubMed 28278391

  • Wedzicha JA, Banerji D, Chapman KR, Vestbo J, Roche N, Ayers RT, Thach C, Fogel R, Patalano F, Vogelmeier CF; FLAME Investigators. Indacaterol-Glycopyrronium versus Salmeterol-Fluticasone for COPD. N Engl J Med. 2016 Jun 9;374(23):2222-34. doi: 10.1056/NEJMoa1516385. Epub 2016 May 15.

    PubMed 27181606

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing QVA149 and Long acting B2 agonist (LABA) and inhaled corticosteroid (ICS) in people with Chronic Obstructive Pulmonary Disease (COPD), run by Novartis Pharmaceuticals at 499 sites in 43 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 8 inclusion and 33 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 16 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 499 sites in Germany, Japan, Argentina, Spain, China and 38 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 16 May 2016). 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?

Rate of COPD Exacerbations (time frame: 52 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 NCT01782326, which also lists 8 linked publications.

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 16 May 2016.

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