Observational Study of Obstructive Lung Disease (NOVELTY)
NCT ID: NCT02760329
Last Updated: 2024-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
12255 participants
OBSERVATIONAL
2016-07-25
2023-05-31
Brief Summary
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Detailed Description
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It is estimated that approximately 7,700 patients with suspected or primary diagnosis of asthma and 7,100 patients with suspected or primary diagnosis of COPD will be enrolled by a diverse set of physicians (e.g. primary care physicians, allergists, pulmonologists) from community and hospital outpatient settings within the countries targeted for NOVELTY.
Exposure(s):
The NOVELTY study is a longitudinal cohort study which does not involve or study a specific medicinal product; it will constitute a disease registry. Information about exposure to treatments as part of routine care will be collected (frequency, treatment, duration).
Sample Size Estimations:
The target minimum number of 100 patients per diagnostic label (asthma or COPD), physician-assessed severity level and country has been chosen to support many basic local reimbursement specific requirements with reasonable precision, and to provide large sample size for scientific questions applicable across severities and countries. Therefore, considering the targeted countries, it is estimated that approximately 7,700 patients with asthma and 7,100 patients with COPD will be enrolled.
Statistical Analysis:
After baseline data collection and each annual data collection, data will be summarized for the population overall and by pre specified subgroups, including by country, demographics, exposures, symptom history, treatment history, concurrent clinical features, treatment setting, socioeconomic setting and access to healthcare, where relevant.
Patients' changes regarding their treatment, disease or severity among and other variables that are observed between baseline and follow-up visits, will also be described.
To identify potential differences in disease diagnosis and severity classifications between physicians and guidelines, data collected on lung function results, symptom questionnaires, exacerbation occurrences and medication will allow the formal and consistent classification of the patients according to relevant international guidelines and other current and future phenotypic/diagnostic classifications.
Multivariable models will be used to assess the following: the occurrence of exacerbations and other conditions, including upper and lower Respiratory Tract Infections (RTIs) and their relationship with clinical outcomes, the relationship between Patient Reported Outcomes (PRO) and disease control with impact on daily activity and quality of life, and the relationship between healthcare resource use overall and related to respiratory diseases with disease severity, clinical outcomes, disease type, etc.
Multivariable analysis techniques will be used to identify phenotypes and endotypes, based on biomarkers and/or clinical parameters that are associated with differential outcomes for symptom burden, clinical evolution and healthcare utilisation.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Chronic airways disease
Patients with suspected or primary diagnosis of asthma or COPD
Blood draw
Biomarkers analyses
Urine
Biomarker analyses
Lung function measurements
FEV1, FVC, PEF, FEF25-75%, IC, calculated FEV1/FVC ratio and calculated FEV1 % predicted
Fractional Exhaled Nitric Oxide (FENO)
Measures level of exhaled nitric oxide.
Interventions
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Blood draw
Biomarkers analyses
Urine
Biomarker analyses
Lung function measurements
FEV1, FVC, PEF, FEF25-75%, IC, calculated FEV1/FVC ratio and calculated FEV1 % predicted
Fractional Exhaled Nitric Oxide (FENO)
Measures level of exhaled nitric oxide.
Eligibility Criteria
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Inclusion Criteria
* Age: 12 years or older (note: in most countries it will only be feasible to include patients aged 18 years or older)
* Willing and able to sign written, informed consent (or having a responsible, legally authorised representative acting on patient's behalf)
* Enrolment from an active clinical practice
Exclusion Criteria
* Patients who, in the opinion of the physician, are unlikely to complete 3 years of follow-up, e.g. poor literacy, substance abuse, life-threatening co-morbidity
* Patients whose primary respiratory diagnosis (i.e. the condition causing most of their respiratory symptoms) is not asthma or COPD (however, a co-diagnosis of another respiratory disease such as bronchiectasis or interstitial lung disease together with asthma or COPD will be accepted)
In addition, the following are considered criteria for exclusion from the exploratory genetic research (donation of blood for DNA and RNA analysis)
* Previous allogeneic bone marrow transplant
* Non-leukocyte depleted whole blood transfusion within 120 days of the date of the genetic sample collection
12 Years
130 Years
ALL
No
Sponsors
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Parexel
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Loma Linda, California, United States
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Long Beach, California, United States
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Roseville, California, United States
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Aurora, Colorado, United States
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Colorado Springs, Colorado, United States
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Clearwater, Florida, United States
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Gainesville, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Plantation, Florida, United States
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Chicago, Illinois, United States
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Normal, Illinois, United States
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Hutchinson, Kansas, United States
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Shreveport, Louisiana, United States
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Fall River, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Buckley, Michigan, United States
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Hamtramck, Michigan, United States
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Lincoln, Nebraska, United States
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Highland Park, New Jersey, United States
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West Berlin, New Jersey, United States
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Albuquerque, New Mexico, United States
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New York, New York, United States
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New York, New York, United States
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Rockville Centre, New York, United States
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The Bronx, New York, United States
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The Bronx, New York, United States
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The Bronx, New York, United States
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Fargo, North Dakota, United States
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Cincinnati, Ohio, United States
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Kettering, Ohio, United States
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Wooster, Ohio, United States
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Altoona, Pennsylvania, United States
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Providence, Rhode Island, United States
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Austin, Texas, United States
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Houston, Texas, United States
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Live Oak, Texas, United States
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San Antonio, Texas, United States
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Richmond, Virginia, United States
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Charleston, West Virginia, United States
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Monte Grande, Buenos Aires, Argentina
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Pilar, Buenos Aires, Argentina
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Tandil, Buenos Aires, Argentina
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Buenos Aires, Buenos Aires F.D., Argentina
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Buenos Aires, Buenos Aires F.D., Argentina
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Concepción del Uruguay, Entre Ríos Province, Argentina
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San Salvador, Entre Ríos Province, Argentina
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San Miguel de Tucumán, Tucumán Province, Argentina
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Buenos Aires, , Argentina
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Buenos Aires, , Argentina
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Buenos Aires, , Argentina
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Buenos Aires, , Argentina
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Córdoba, , Argentina
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Mendoza, , Argentina
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Blacktown, New South Wales, Australia
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Camperdown, New South Wales, Australia
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Coffs Harbour, New South Wales, Australia
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Concord, New South Wales, Australia
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Kanwal, New South Wales, Australia
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Kingswood, New South Wales, Australia
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Liverpool, New South Wales, Australia
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Miranda, New South Wales, Australia
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New Lambton, New South Wales, Australia
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Randwick, New South Wales, Australia
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Sedney, New South Wales, Australia
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Wamberal, New South Wales, Australia
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Brisbane, Queensland, Australia
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Redcliffe, Queensland, Australia
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South Brisbane, Queensland, Australia
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Bedford Park, South Australia, Australia
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Happy Valley, South Australia, Australia
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Woodville South, South Australia, Australia
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Frankston, Victoria, Australia
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Parkville, Victoria, Australia
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Crawley, Western Australia, Australia
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Spearwood, Western Australia, Australia
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Goiânia, Goiás, Brazil
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Uberlândia, Minas Gerais, Brazil
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Blumenau, Santa Catarina, Brazil
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Rio de Janeiro, , Brazil
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São Paulo, , Brazil
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Edmonton, Alberta, Canada
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Edmonton, Alberta, Canada
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Vancouver, British Columbia, Canada
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New Brunswick, New Brunswick, Canada
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Burlington, Ontario, Canada
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Downsview, Ontario, Canada
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Fort Erie, Ontario, Canada
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Hamilton, Ontario, Canada
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London, Ontario, Canada
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Mississauga, Ontario, Canada
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Oshawa, Ontario, Canada
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Windsor, Ontario, Canada
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Windsor, Ontario, Canada
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Saint-Charles-Borromée, Quebec, Canada
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Québec, , Canada
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Beijing, Beijing Municipality, China
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Beijing, Beijing Municipality, China
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Beijing, Beijing Municipality, China
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Sichuan, Chengdu, China
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Dongguan, Guangdong, China
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Dongguan, Guangdong, China
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Shantou, Guangdong, China
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Shenzhen, Guangdong, China
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Shenzhen, Guangdong, China
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Shenzhen, Guangdong, China
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Guangdong, Guangzhou, China
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Changshacun, Henan, China
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Zhengzhou, Henan, China
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Shiyan, Hubei, China
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Baotou, Inner Mongolia, China
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Hohhot, Inner Mongolia, China
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Nanjing, Jiangsu, China
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Suzhou, Jiangsu, China
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Yangzhou, Jiangsu, China
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Nanchang, Jiangxi, China
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Changchun, Jilin, China
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Yanji, Jilin, China
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Xi'an, Shaanxi, China
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Jinan, Shandong, China
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Weifang, Shandong, China
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Shanghai, Shanghai Municipality, China
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Hangzhou, Zhejiang, China
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Jinhua, Zhejiang, China
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Bogotá, Bogota D.C., Colombia
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Bogotá, Bogota D.C., Colombia
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Bucaramanga, Bogota D.C., Colombia
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Manizales, Caldas Department, Colombia
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Zipaquirá, Cundinamarca, Colombia
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Villavicencio, Meta Department, Colombia
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Antioquia, , Colombia
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Aarhus N, Central Jutland, Denmark
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Viby J, Central Jutland, Denmark
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Pau, Aquitaine, France
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Lyon, Auvergne-Rhône-Alpes, France
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Clermont-Ferrand, Auvergne, France
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Strasbourg, Bas-Rhin, France
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Brest, Brittany Region, France
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Brest, Brittany Region, France
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Caen, Calvados, France
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Dijon, Côte-d'Or, France
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Besançon, Franche-Comté, France
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Pessac, Gironde, France
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Mulhouse, Haut-Rhin, France
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Limoges, Haute-Vienne, France
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Tarbes, Hautes-Pyrénées, France
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Montpellier, Hérault, France
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Orléans, Loiret, France
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Nancy, Meurthe-et-Moselle, France
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Bersée, Nord, France
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Lille, Nord, France
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Aix-en-Provence, Provence-Alpes-Côte d'Azur Region, France
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Biarritz, Pyrénées-Atlantiques, France
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Villefranche-sur-Saône, Rhône, France
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Le Mans, Sarthe, France
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Montvilliers, Seine-Maritime, France
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Rouen, Seine-Maritime, France
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Créteil, Val-de-Marne, France
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Paris, , France
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Paris, Île-de-France Region, France
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Bruchsal, Baden-Wurttemberg, Germany
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Heidelberg, Baden-Wurttemberg, Germany
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Augsburg, Bavaria, Germany
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Munich, Bavaria, Germany
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Marburg, Hesse, Germany
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Peine, Lower Saxony, Germany
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Ibbenbueren, North Rhine-Westphalia, Germany
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Ratingen, North Rhine-Westphalia, Germany
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Dillingen, Saarland, Germany
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Dresden, Saxony, Germany
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Leipzig, Saxony, Germany
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Halberstadt, Saxony-Anhalt, Germany
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Lübeck, Schleswig-Holstein, Germany
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Reinfeld, Schleswig-Holstein, Germany
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Schleswig, Schleswig-Holstein, Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Chieti, Abruzzo, Italy
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Rome, Lazio, Italy
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Mantova, Lombardy, Italy
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Monza, Milano, Italy
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Montescano, Pavia, Italy
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Orbassano, Piedmont, Italy
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Torre Del Greco (Napoli), Salerno, Italy
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Sassari, Sardinia, Italy
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Gravina di Catania, Sicily, Italy
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Torrette Di Ancona, The Marches, Italy
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Catania, , Italy
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Ferrara, , Italy
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Florence, , Italy
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Foggia, , Italy
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Genova, , Italy
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Livorno, , Italy
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Messina, , Italy
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Modena, , Italy
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Napoli, , Italy
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Palermo, , Italy
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Pordenone, , Italy
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Roma, , Italy
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Roma, , Italy
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Roma, , Italy
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Nagoya, Aichi-ken, Japan
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Fukuoka, Fukuoka, Japan
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Kitakyushu, Fukuoka, Japan
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Kurume, Fukuoka, Japan
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Omuta, Fukuoka, Japan
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Itami, Hyōgo, Japan
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Kobe, Hyōgo, Japan
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Higashiibaraki-gun, Ibaraki, Japan
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Kanazawa, Ishikawa-ken, Japan
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Kanazawa, Ishikawa-ken, Japan
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Yokohama, Kanagawa, Japan
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Ishinomaki, Miyagi, Japan
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Kishiwada, Osaka, Japan
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Matsue, Shimane, Japan
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Shizuoka, Shizuoka, Shizuoka, Japan
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Shimotsuga-gun, Tochigi, Japan
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Chuo-ku, Tokyo, Japan
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Kiyose, Tokyo, Japan
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Nakano-ku, Tokyo, Japan
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Fukuoka, , Japan
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Fukushima, , Japan
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Shizuoka, , Japan
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Toyama, , Japan
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Yamagata, , Japan
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Pachuca, Hidalgo, Mexico
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Guadalajara, Jalisco, Mexico
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Guadalajara, Jalisco, Mexico
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Mexico City, Mexico City, Mexico
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Monterrey, Nuevo León, Mexico
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Villahermosa, Tabasco, Mexico
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México, , Mexico
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Arnhem, Gelderland, Netherlands
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Nijmegen, Gelderland, Netherlands
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Zutphen, Gelderland, Netherlands
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Horn, Limburg, Netherlands
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Breda, North Brabant, Netherlands
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Veldhoven, North Brabant, Netherlands
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Alkmaar, North Holland, Netherlands
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Enschede, Overijssel, Netherlands
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Rotterdam, South Holland, Netherlands
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Nieuwegein, Utrecht, Netherlands
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Groningen, , Netherlands
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Jassheim, Akershus, Norway
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Lørenskog, Akershus, Norway
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Trollåsen, Akershus, Norway
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Tananger, Rogaland, Norway
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Oslo, , Norway
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Trondheim, , Norway
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Daegu, Daegu Gwang'yeogsi, South Korea
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Chuncheon, Gang'weondo, South Korea
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Gwangju, Gwangju Gwang'yeogsi, South Korea
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Anyang-si, Gyeonggido, South Korea
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Gyeonggi-do, Gyeonggido, South Korea
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Seongnam-si, Gyeonggido, South Korea
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Suwon, Gyeonggido, South Korea
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Incheon, Incheon Gwang'yeogsi, South Korea
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Jeonju, Jeonrabugdo, South Korea
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Seoul, Seoul Teugbyeolsi, South Korea
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Seoul, Seoul Teugbyeolsi, South Korea
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Seoul, Seoul Teugbyeolsi, South Korea
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Seoul, Seoul Teugbyeolsi, South Korea
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Seoul, Seoul Teugbyeolsi, South Korea
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Seoul, Seoul Teugbyeolsi, South Korea
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Seoul, Seoul Teugbyeolsi, South Korea
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Seoul, Seoul Teugbyeolsi, South Korea
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Seoul, Seoul Teugbyeolsi, South Korea
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Palma de Mallorca, Balearic Islands, Spain
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Badalona, Barcelona, Spain
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Centelles, Barcelona, Spain
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Santa Cruz de Tenerife, Canary Islands, Spain
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Alcázar de San Juan, Ciudad Real, Spain
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Palmones, Cádiz, Spain
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Alcalá de Henares, Madrid, Spain
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Móstoles, Madrid, Spain
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Pozuelo de Alarcón, Madrid, Spain
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Torrelaguna, Madrid, Spain
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Cartagena, Murcia, Spain
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Pamplona, Navarre, Spain
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Vigo, Pontevedra, Spain
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Vigo, Pontevedra, Spain
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Oviedo, Principality of Asturias, Spain
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Barakaldo, Vizcaya, Spain
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Badajoz, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Burgos, , Spain
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Granada, , Spain
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Lugo, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Málaga, , Spain
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Málaga, , Spain
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Murcia, , Spain
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Murcia, , Spain
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Valladolid, , Spain
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Zaragoza, , Spain
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Värnamo, Jönköping County, Sweden
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Lund, Skåne County, Sweden
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Stockholm, Stockholm County, Sweden
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Uppsala, Uppsala County, Sweden
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Uppsala, Uppsala County, Sweden
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Gothenburg, Västra Götaland County, Sweden
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Swansea, Carmarthenshire, United Kingdom
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Chelmsford, Essex, United Kingdom
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Southampton, Hampshire, United Kingdom
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Watford, Hertfordshire, United Kingdom
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Middlesbrough, Kensington and Chelsea, United Kingdom
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Hull, Kingston Upon Hull, City of, United Kingdom
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Thornton-Cleveleys, Lancashire, United Kingdom
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London, London, City of, United Kingdom
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Wishaw, North Lanarkshire, United Kingdom
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York, North Yorkshire, United Kingdom
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York, North Yorkshire, United Kingdom
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York, North Yorkshire, United Kingdom
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Belfast, Northern Ireland, United Kingdom
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Nottingham, Nottinghamshire, United Kingdom
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Tyne and Wear, South Tyneside, United Kingdom
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Warwickshire, Warwickshire, United Kingdom
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Pickering, York, United Kingdom
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Birmingham, , United Kingdom
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Liverpool, , United Kingdom
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Manchester, , United Kingdom
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Manchester, , United Kingdom
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Newport, , United Kingdom
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York, , United Kingdom
Countries
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References
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Beasley R, Hughes R, Agusti A, Calverley P, Chipps B, Del Olmo R, Papi A, Price D, Inoue H, Janson C, van den Berge M, Reddel H, Mullerova H, Mangelis A, Rapsomaniki E. Prevalence and Clinical Characteristics of Persistent Airflow Limitation in the NOVELTY Cohort. Ann Am Thorac Soc. 2025 Sep 17. doi: 10.1513/AnnalsATS.202412-1273OC. Online ahead of print.
Papi A, Hughes R, Del Olmo R, Agusti A, Chipps BE, Make B, Tomaszewski E, Peres Da Costa K, Srivastava D, Vestbo J, Janson C, Burgel PR, Price D. Relationships between symptoms and lung function in asthma and/or chronic obstructive pulmonary disease in a real-life setting: the NOVEL observational longiTudinal studY. Ther Adv Respir Dis. 2024 Jan-Dec;18:17534666241254212. doi: 10.1177/17534666241254212.
Agusti A, Hughes R, Rapsomaki E, Make B, Del Olmo R, Papi A, Price D, Benton L, Franzen S, Vestbo J, Mullerova H. The many faces of COPD in real life: a longitudinal analysis of the NOVELTY cohort. ERJ Open Res. 2024 Feb 12;10(1):00895-2023. doi: 10.1183/23120541.00895-2023. eCollection 2024 Jan.
Ding B, Chen S, Rapsomaniki E, Quinton A, Cook W, Reddel HK, Papi A; NOVELTY Scientific Community; NOVELTY study investigators. Burden of Uncontrolled Severe Asthma With and Without Elevated Type-2 Inflammatory Biomarkers. J Allergy Clin Immunol Pract. 2024 Apr;12(4):970-982. doi: 10.1016/j.jaip.2023.12.021. Epub 2023 Dec 22.
Ding B, Chen S, Srivastava D, Quinton A, Cook W, Papi A, Reddel HK; NOVELTY Scientific Community; NOVELTY study investigators. Symptom Burden, Health Status, and Productivity in Patients with Uncontrolled and Controlled Severe Asthma in NOVELTY. J Asthma Allergy. 2023 Jun 11;16:611-624. doi: 10.2147/JAA.S401445. eCollection 2023.
Hughes R, Rapsomaniki E, Bansal AT, Vestbo J, Price D, Agusti A, Beasley R, Fageras M, Alacqua M, Papi A, Mullerova H, Reddel HK; NOVELTY Scientific Community; NOVELTY study investigators. Cluster Analyses From the Real-World NOVELTY Study: Six Clusters Across the Asthma-COPD Spectrum. J Allergy Clin Immunol Pract. 2023 Sep;11(9):2803-2811. doi: 10.1016/j.jaip.2023.05.013. Epub 2023 May 23.
Tomaszewski EL, Atkinson MJ, Janson C, Karlsson N, Make B, Price D, Reddel HK, Vogelmeier CF, Mullerova H, Jones PW; NOVELTY Scientific Community; NOVELTY study investigators. Chronic Airways Assessment Test: psychometric properties in patients with asthma and/or COPD. Respir Res. 2023 Apr 8;24(1):106. doi: 10.1186/s12931-023-02394-6.
Marshall H, Wild JM, Smith LJ, Hardaker L, Fihn-Wikander T, Mullerova H, Hughes R. Functional imaging in asthma and COPD: design of the NOVELTY ADPro substudy. ERJ Open Res. 2023 Apr 3;9(2):00344-2022. doi: 10.1183/23120541.00344-2022. eCollection 2023 Mar.
Hughes R, Rapsomaniki E, Janson C, Keen C, Make BJ, Burgel PR, Tomaszewski EL, Mullerova H, Reddel HK; NOVELTY study investigators. Frequent productive cough: Symptom burden and future exacerbation risk among patients with asthma and/or COPD in the NOVELTY study. Respir Med. 2022 Aug-Sep;200:106921. doi: 10.1016/j.rmed.2022.106921. Epub 2022 Jun 20.
Reddel HK, Vestbo J, Agusti A, Anderson GP, Bansal AT, Beasley R, Bel EH, Janson C, Make B, Pavord ID, Price D, Rapsomaniki E, Karlsson N, Finch DK, Nuevo J, de Giorgio-Miller A, Alacqua M, Hughes R, Mullerova H, Gerhardsson de Verdier M; NOVELTY study investigators. Heterogeneity within and between physician-diagnosed asthma and/or COPD: NOVELTY cohort. Eur Respir J. 2021 Sep 23;58(3):2003927. doi: 10.1183/13993003.03927-2020. Print 2021 Sep.
Karlsson N, Atkinson MJ, Mullerova H, Alacqua M, Keen C, Hughes R, Janson C, Make B, Price D, Reddel HK; NOVELTY study investigators. Validation of a diagnosis-agnostic symptom questionnaire for asthma and/or COPD. ERJ Open Res. 2021 Feb 1;7(1):00828-2020. doi: 10.1183/23120541.00828-2020. eCollection 2021 Jan.
Reddel HK, Gerhardsson de Verdier M, Agusti A, Anderson G, Beasley R, Bel EH, Janson C, Make B, Martin RJ, Pavord I, Price D, Keen C, Gardev A, Rennard S, Svereus A, Bansal AT, Brannman L, Karlsson N, Nuevo J, Nyberg F, Young SS, Vestbo J. Prospective observational study in patients with obstructive lung disease: NOVELTY design. ERJ Open Res. 2019 Feb 1;5(1):00036-2018. doi: 10.1183/23120541.00036-2018. eCollection 2019 Feb.
Related Links
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NOVELTY\_protocol\_v1\_with\_amendment\_history\_REDACTED
Other Identifiers
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D2287R00103
Identifier Type: -
Identifier Source: org_study_id
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