QVA vs. Salmeterol/Fluticasone, 52-week Exacerbation Study, FLAME (EFfect of Indacaterol Glycopyronium Vs Fluticasone Salmeterol on COPD Exacerbations)
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).
1 other identifier
interventional
3,362
41 countries
470
Brief Summary
This study will assess the efficacy, safety and tolerability of QVA149 in patients with moderate to very severe COPD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2013
470 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 30, 2013
CompletedFirst Posted
Study publicly available on registry
February 1, 2013
CompletedStudy Start
First participant enrolled
July 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedResults Posted
Study results publicly available
May 16, 2016
CompletedMay 16, 2016
May 1, 2016
2.2 years
January 30, 2013
May 4, 2016
May 5, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
52 weeks
Secondary Outcomes (27)
Time to First COPD Exacerbation.
52 weeks
Rate of Moderate to Severe COPD Exacerbations.
52 weeks
Time to First Moderate to Severe COPD Exacerbation.
52 weeks.
Rate of Moderate to Severe COPD Exacerbations Requiring Treatment With Systemic Corticosteroids
52 weeks
Rate of Moderate to Severe COPD Exacerbations Requiring Treatment With Antibiotics
52 weeks
- +22 more secondary outcomes
Study Arms (2)
QVA149
EXPERIMENTALQVA149 (110/50 μg) once daily
Long acting B2 agonist (LABA) and inhaled corticosteroid (ICS)
ACTIVE COMPARATORSalmeterol/fluticasone (50/500μg) b.i.d
Interventions
QVA149 will be supplied in a capsule form in blister packs for use in the Novartis Concept 1 SDDPI.
Salmeterol/fluticasone dry inhalation powder delivered via the Accuhaler device.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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 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
- +17 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (499)
Novartis Investigative Site
Ciudad de Buenos Aires, Argentina, C1425AUA, Argentina
Novartis Investigative Site
Buenos Aires, Buenos Aires, 1425, Argentina
Novartis Investigative Site
Buenos Aires, Buenos Aires, C1120AAC, Argentina
Novartis Investigative Site
Caba, Buenos Aires, 1122, Argentina
Novartis Investigative Site
Caba, Buenos Aires, C1056ABJ, Argentina
Novartis Investigative Site
Caba, Buenos Aires, C1122AAK, Argentina
Novartis Investigative Site
Caba, Buenos Aires, C1414AIF, Argentina
Novartis Investigative Site
Caba, Buenos Aires, C1424BSF, Argentina
Novartis Investigative Site
Caba, Buenos Aires, C1425BEA, Argentina
Novartis Investigative Site
Caba, Buenos Aires, C1425BEN, Argentina
Novartis Investigative Site
Caba, Buenos Aires, C1426ABP, Argentina
Novartis Investigative Site
Lanús, Buenos Aires, B8000XAV, Argentina
Novartis Investigative Site
Mar del Plata, Buenos Aires, 7600, Argentina
Novartis Investigative Site
Mar del Plata, Buenos Aires, B7600FZN, Argentina
Novartis Investigative Site
Mar del Plata, Buenos Aires, B7600, Argentina
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Buenos Aires, Buenos Aires F.D., C1028AAP, Argentina
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Concepción del Uruguay, Entre Ríos Province, 3260, Argentina
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Mendoza, Mendoza Province, 5500, Argentina
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Mendoza, Mendoza Province, M5500CBA, Argentina
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Salta, Salta Province, 4000, Argentina
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Rosario, Santa Fe Province, S2000AII, Argentina
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Rosario, Santa Fe Province, S2000DBS, Argentina
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Santa Fe, Santa Fe Province, S3000FIL, Argentina
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San Miguel de Tucumán, Tucumán Province, 4000, Argentina
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San Miguel de Tucumán, Tucumán Province, T4000IFL, Argentina
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Feldbach, Austria, 8330, Austria
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Feldkirch, Austria, 6800, Austria
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Graz, Austria, A-8036, Austria
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Grieskirchen, Austria, 4710, Austria
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Linz, Austria, 4020, Austria
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Thalheim bei Wels, Austria, 4600, Austria
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Wels, Austria, 4600, Austria
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Innsbruck, Tyrol, 6020, Austria
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Salzburg, 5020, Austria
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Vienna, A-1230, Austria
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Gosselies, BEL, 6041, Belgium
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Genk, Limburg, 3600, Belgium
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Luxembourg, Luxembourg, 1210, Belgium
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Aalst, 9300, Belgium
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Brussels, 1000, Belgium
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Brussels, 1070, Belgium
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Brussels, 1090, Belgium
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Brussels, 1200, Belgium
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Erpent, 5101, Belgium
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Ghent, 9000, Belgium
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Gilly, 6060, Belgium
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Hasselt, 3500, Belgium
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Leuven, 3000, Belgium
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Liège, 4000, Belgium
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Ostend, 8400, Belgium
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Roeselare, 8800, Belgium
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Turnhout, 2300, Belgium
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Wavre, 1301, Belgium
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Rousse, Bulgaria, 7002, Bulgaria
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Sofia, Bulgaria, 1431, Bulgaria
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Varna, Bulgaria, 9020, Bulgaria
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Gabrovo, 5300, Bulgaria
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Pleven, 5800, Bulgaria
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Plovdiv, 4002, Bulgaria
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Sofia, 1431, Bulgaria
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Stara Zagora, 6000, Bulgaria
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Troyan Municipality, 5600, Bulgaria
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Calgary, Alberta, T2N 4n1, Canada
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Vancouver, British Columbia, V5Z 4E1, Canada
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Moncton, New Brunswick, E1G 1A7, Canada
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Burlington, Ontario, L7N 3V2, Canada
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Downsview, Ontario, M3N 2Z9, Canada
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Toronto, Ontario, M5T 3A9, Canada
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Mirabel, Quebec, J7J 2K8, Canada
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Montreal, Quebec, H1M 1B1, Canada
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Montreal, Quebec, H3G 1L5, Canada
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Québec, Quebec, G1N 4V3, Canada
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Saint-Charles-Borromée, Quebec, J6E 2B4, Canada
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Sherbrooke, Quebec, J1H 5N4, Canada
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Santiago, Santiago Metropolitan, Chile
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Quillota, 2260877, Chile
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Santiago, 8910131, Chile
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Beijing, Beijing Municipality, 100023, China
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Beijing, Beijing Municipality, 100730, China
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Guangzhou, Guangdong, 510120, China
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Haikou, Hainan, 570311, China
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Shijiazhuang, Hebei, 050000, China
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Changsha, Hunan, 410003, China
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Nanjing, Jiangsu, 210029, China
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Suzhou, Jiangsu, 215006, China
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Nanchang, Jiangxi, 330006, China
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Shengyang, Liaoning, 110016, China
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Shanghai, Shanghai Municipality, 200433, China
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Xi’an, Shanxi, 710032, China
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Chengdu, Sichuan, 610041, China
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Hangzhou, Zhejiang, 310006, China
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Beijing, 100050, China
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Chongqing, 400037, China
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Chongqing, 400038, China
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Guangzhou, 510010, China
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Shanghai, 200025, China
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Tianjin, 300052, China
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Bogota, Cundinamarca, Colombia
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Floridablanca, Santander Department, 57-7, Colombia
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Armenia, Colombia
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Medellín, Colombia
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Zagreb, Croatia, 10 000, Croatia
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Karlovac, 47000, Croatia
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Zagreb, 10000, Croatia
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Cvikov, Czech Republic, 471 54, Czechia
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Český Krumlov, Czech Republic, 381 01, Czechia
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Jindrichuv Hradec III, Czech Republic, 377 01, Czechia
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Liberec, Czech Republic, 460 01, Czechia
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Mělník, Czech Republic, 267 01, Czechia
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Ostrava, Czech Republic, 708 68, Czechia
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Ostrava - Hrabuvka, Czech Republic, 70030, Czechia
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Pardubice, Czech Republic, 530 09, Czechia
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Prague, Czech Republic, 108 00, Czechia
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Prague, Czech Republic, 142 00, Czechia
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Prague, Czech Republic, 158 00, Czechia
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Prague, Czech Republic, 169 00, Czechia
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Praha 6 - Repy, Czech Republic, 163 00, Czechia
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Strakonice, Czech Republic, 38601, Czechia
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Teplice, Czech Republic, 415 01, Czechia
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Žatec, Czech Republic, 438 01, Czechia
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Benešov, 256 30, Czechia
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Olomouc, 775 20, Czechia
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Aalborg, Denmark, DK-9000, Denmark
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Hellerup, Denmark, DK-2900, Denmark
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Hvidovre, Denmark, DK-2650, Denmark
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Roskilde, Denmark, DK-4000, Denmark
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Silkeborg, Denmark, 8600, Denmark
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Sønderborg, Denmark, DK-6400, Denmark
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Aarhus, DK-8000, Denmark
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Copenhagen NV, DK-2400, Denmark
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Næstved, 4700, Denmark
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Tartu, Estonia, 51014, Estonia
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Tallinn, 13419, Estonia
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Tallinn, 13619, Estonia
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Turku, Finland, FIN-20100, Finland
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Helsinki, 00290, Finland
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HUS, 00029, Finland
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Jyväskylä, 40100, Finland
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Kuopio, FIN-70211, Finland
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Pori, FIN-28500, Finland
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Beuvry, France, 62660, France
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Angers, 49000, France
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Briis-sous-Forges, 91640, France
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Cournonterral, 34660, France
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Lyon, 69317, France
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Montpellier, 34059, France
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Nantes, 44000, France
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Nantes, 44300, France
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Nîmes, 30029, France
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Pessac, 33604, France
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Reims, 51092, France
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Saint-Génis-des-Fontaines, 66740, France
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Heidelberg, Baden-Wurttemberg, 69126, Germany
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Berlin, Germany, 10117, Germany
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Berlin, Germany, 10969, Germany
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Berlin, Germany, 12099, Germany
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Dresden, Germany, 01307, Germany
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Leipzig, Germany, 04207, Germany
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Marburg, Germany, 35037, Germany
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Potsdam, Germany, 14467, Germany
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Hanover, Lower Saxony, 30159, Germany
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Peine, Lower Saxony, 31224, Germany
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Koblenz, North Rhine-Westphalia, 56068, Germany
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Cottbus, Saxony, 03050, Germany
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Geesthacht, Schleswig-Holstein, 12502, Germany
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Berlin, State of Berlin, 10117, Germany
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Berlin, State of Berlin, 10119, Germany
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Aschaffenburg, 63739, Germany
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Bad Wörishofen, 86825, Germany
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Bamberg, 96049, Germany
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Berlin, 10367, Germany
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Berlin, 10789, Germany
Novartis Investigative Site
Berlin, 12043, Germany
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Berlin, 12203, Germany
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Berlin, 13086, Germany
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Berlin, 13156, Germany
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Berlin, 13581, Germany
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Bielefeld, 33617, Germany
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Bochum, 44787, Germany
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Bonn, 53119, Germany
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Bonn, 53123, Germany
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Cologne, 51069, Germany
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Delitzsch, 04509, Germany
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Duisburg, 47057, Germany
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Erlangen, 91052, Germany
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Frankfurt, 60389, Germany
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Frankfurt, 60596, Germany
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Freudenberg, 57258, Germany
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Gauting, 82131, Germany
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Hagen, 59065, Germany
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Halle, 06108, Germany
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Hamburg, 20253, Germany
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Hamburg, 20354, Germany
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Hamburg, 22299, Germany
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Hannover Münden, 34346, Germany
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Kassel, 34121, Germany
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Landsberg, 86899, Germany
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Leipzig, 04103, Germany
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Leipzig, 04275, Germany
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Leipzig, 04357, Germany
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Lübeck, 23552, Germany
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Lübeck, 23558, Germany
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Minden, 32423, Germany
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München, 80335, Germany
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Neu-Isenburg, 63263, Germany
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Neumünster, 24534, Germany
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Oranienburg, 16515, Germany
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Potsdam, 14469, Germany
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Prien A. Chiemsee, 83209, Germany
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Ratingen, 40878, Germany
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Reinfeld, 23858, Germany
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Rüdersdorf, 15562, Germany
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Schleswig, 24837, Germany
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Schwabach, 91126, Germany
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Solingen, 42651, Germany
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Stade, 21680, Germany
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Teuchern, 06682, Germany
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Ulm, 89073, Germany
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Warendorf, 48231, Germany
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Weinheim, 69469, Germany
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Wissen, 57537, Germany
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Witten, 58452, Germany
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Athens, Greece, 12462, Greece
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Serres, Greece, GR 62 100, Greece
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Athens, GR, 106 76, Greece
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Athens, GR, 115 27, Greece
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Larissa, GR, 411 10, Greece
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Rethymno, GR, 741 00, Greece
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Thessaloniki, GR, 564 03, Greece
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Athens, GR 115 27, Greece
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Heraklion Crete, GR 711 10, Greece
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Thessaloniki, GR 570 10, Greece
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Guatemala City, Departamento de Guatemala, 01010, Guatemala
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Guatemala City, Departamento de Guatemala, 01011, Guatemala
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Ciudad, Gautemala, 01010, Guatemala
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Kowloon, Hong Kong, Hong Kong
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New Territories, Hong Kong, Hong Kong
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Komárom, Hungary, 2900, Hungary
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Budapest, 1121, Hungary
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Budapest, 1125, Hungary
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Budapest, 1145, Hungary
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Deszk, 6772, Hungary
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Törökbálint, 2045, Hungary
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Reykjavik, IS-109, Iceland
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Hyderabad, Andhra Pradesh, 500004, India
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Vijayawada, Andhra Pradesh, 520 002, India
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Visakhapatnam, Andhra Pradesh, 530002, India
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Ahmedabad, Gujarat, 380 008, India
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Ahmedabad, Gujarat, 380 060, India
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Gurgaon, Haryana, 122 002, India
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Manipal, Karnataka, 576 104, India
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Nagpur, Maharashtra, 400 012, India
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Nagpur, Maharashtra, 440010, India
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Ludhiana, Punjab, 141001, India
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Chennai, Tamil Nadu, 641037, India
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Coimbatore, Tamil Nadu, 641 018, India
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Coimbatore, Tamil Nadu, 641 045., India
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Coimbatore, Tamil Nadu, 641037, India
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Kolkata, West Bengal, 700 107, India
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Bangalore, 560 034, India
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Ancona, AN, 60020, Italy
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Cassano delle Murge, BA, 70020, Italy
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Crema, CR, 26013, Italy
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Foggia, FG, 71100, Italy
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Florence, FI, 50100, Italy
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Genova, GE, 16132, Italy
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Milan, MI, 20126, Italy
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Pavullo nel Frignano, MO, 41026, Italy
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Palermo, PA, 90146, Italy
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Cittadella, PD, 35013, Italy
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Pisa, PI, 56124, Italy
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Pordenone, PN, 33170, Italy
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Pavia, PV, 27100, Italy
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Reggio Emilia, RE, 42123, Italy
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Cuasso al Monte, VA, 21050, Italy
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Tradate, VA, 21049, Italy
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Negrar, VR, 37024, Italy
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Napoli, 80131, Italy
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Komaki, Aichi-ken, 485-0041, Japan
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Nagoya, Aichi-ken, 457-8511, Japan
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Seto, Aichi-ken, 489-8642, Japan
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Toyoake, Aichi-ken, 470-1192, Japan
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Fukuoka, Fukuoka, 811-1394, Japan
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Fukuoka, Fukuoka, 812-0033, Japan
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Yanagawa, Fukuoka, 832-0059, Japan
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Asahikawa, Hokkaido, 070-8644, Japan
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Sapporo, Hokkaido, 060-8648, Japan
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Sapporo, Hokkaido, 062-8618, Japan
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Himeji, Hyōgo, 672-8064, Japan
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Sakaidechō, Kagawa-ken, 762-8550, Japan
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Takamatsu, Kagawa-ken, 760-8538, Japan
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Kawasaki, Kanagawa, 210-0852, Japan
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Kochi, Kochi, 780-8077, Japan
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Kōshi, Kumamoto, 861-1196, Japan
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Kyoto, Kyoto, 606-8507, Japan
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Matsusaka, Mie-ken, 515-8544, Japan
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Sendai, Miyagi, 980-8574, Japan
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Kishiwada, Osaka, 596-8501, Japan
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Koshigaya, Saitama, 343-0851, Japan
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Hamamatsu, Shizuoka, 430-8525, Japan
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Hamamatsu, Shizuoka, 434-8511, Japan
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Iwata, Shizuoka, 438-8550, Japan
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Bunkyo-ku, Tokyo, 113-8431, Japan
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Related Publications (8)
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. 2025 Dec 15:thorax-2025-223282. doi: 10.1136/thorax-2025-223282. Online ahead of print.
PMID: 41402044DERIVEDMathioudakis 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.
PMID: 38992490DERIVEDMackay 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.
PMID: 32321518DERIVEDWedzicha 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.
PMID: 30621717DERIVEDFrent 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.
PMID: 30019939DERIVEDAnzueto 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.
PMID: 29925383DERIVEDRoche 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.
PMID: 28278391DERIVEDWedzicha 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.
PMID: 27181606DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 30, 2013
First Posted
February 1, 2013
Study Start
July 1, 2013
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
May 16, 2016
Results First Posted
May 16, 2016
Record last verified: 2016-05