Observational Study of Obstructive Lung Disease (NOVELTY) (NOVELTY)

A NOVEL Observational longiTudinal studY on Patients With Asthma and/or COPD to Describe Patient Characteristics, Treatment Patterns and the Burden of Illness Over Time and to Identify Phenotypes and Endotypes.

The NOVEL Observational longiTudinal studY (NOVELTY) is an observational study of obstructive lung disease and is a multi-country, multi-centre, prospective, longitudinal cohort study which will recruit patients with a diagnosis, or suspected diagnosis, of asthma and/or Chronic Obstructive Pulmonary Disease (COPD). Patients will undergo clinical assessments and receive standard medical care as determined by their treating physician. Patients enrolled in NOVELTY will be followed up yearly by their treating physician for a total duration of three years. In addition, patients will be followed up remotely every 3 months. The NOVELTY study will collect data currently lacking to allow for multinational data collection to fill regional/local gaps and improve comparability across regions.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease; Asthma; COPD
• Intervention / Treatment: Procedure: Blood draw; Procedure: Urine; Procedure: Lung function measurements; Procedure: Fractional Exhaled Nitric Oxide (FENO)

Detailed Description

The NOVELTY study is a multi-country, multicentre, observational, prospective, longitudinal cohort study which will include patients with a physician diagnosis, or suspected diagnosis, of asthma and/or COPD. Patients will undergo clinical assessments and receive standard medical care as determined by the treating physician. All patients enrolled in the NOVELTY study will be followed up yearly by their treating physician for a total duration of three years. In addition, patients are expected to be followed up remotely once every quarter.

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.

• Study Type: Observational
• Enrollment (Actual): 12255

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1181ACH
    • Research Site
  • Buenos Aires, Argentina, C1425BEN
    • Research Site
  • Buenos Aires, Argentina, 1015
    • Research Site
  • Buenos Aires, Argentina, C1028AAP
    • Research Site
  • Córdoba, Argentina, 5000
    • Research Site
  • Mendoza, Argentina, 5500
    • Research Site
  • Buenos Aires
    • Monte Grande, Buenos Aires, Argentina, 1842
      • Research Site
    • Pilar, Buenos Aires, Argentina, 1629
      • Research Site
    • Tandil, Buenos Aires, Argentina, 7000
      • Research Site
  • Ciudad Autónoma De Buenos Aires
    • Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina, C1121ABE
      • Research Site
    • Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina, C1431FWO
      • Research Site
  • Entre Ríos
    • Concepcion del Uruguay, Entre Ríos, Argentina, 3260
      • Research Site
    • San Salvador, Entre Ríos, Argentina, E3218
      • Research Site
  • Tucumán
    • San Miguel de Tucumán, Tucumán, Argentina, 4000
      • Research Site
• Australia
  • New South Wales
    • Blacktown, New South Wales, Australia, 2148
      • Research Site
    • Camperdown, New South Wales, Australia, 2050
      • Research Site
    • Coffs Harbour, New South Wales, Australia, 2450
      • Research Site
    • Concord, New South Wales, Australia, 2139
      • Research Site
    • Kanwal, New South Wales, Australia, 2259
      • Research Site
    • Kingswood, New South Wales, Australia, 2747
      • Research Site
    • Liverpool, New South Wales, Australia, 2170
      • Research Site
    • Miranda, New South Wales, Australia, 2228
      • Research Site
    • New Lambton, New South Wales, Australia, 2305
      • Research Site
    • Randwick, New South Wales, Australia, 2031
      • Research Site
    • Sedney, New South Wales, Australia, 2109
      • Research Site
    • Wamberal, New South Wales, Australia, 2260
      • Research Site
  • Queensland
    • Brisbane, Queensland, Australia, 4102
      • Research Site
    • Redcliffe, Queensland, Australia, 4020
      • Research Site
    • South Brisbane, Queensland, Australia, 4101
      • Research Site
  • South Australia
    • Bedford Park, South Australia, Australia, 5042
      • Research Site
    • Happy Valley, South Australia, Australia, 5159
      • Research Site
    • Woodville South, South Australia, Australia, 5011
      • Research Site
  • Victoria
    • Frankston, Victoria, Australia, 3199
      • Research Site
    • Parkville, Victoria, Australia, 3050
      • Research Site
  • Western Australia
    • Crawley, Western Australia, Australia, 6009
      • Research Site
    • Spearwood, Western Australia, Australia, 6163
      • Research Site
• Brazil
  • Rio de Janeiro, Brazil, 21941-913
    • Research Site
  • São Paulo, Brazil, 01221-020
    • Research Site
  • Goiás
    • Goiânia, Goiás, Brazil, 74110 - 030
      • Research Site
  • Minas Gerais
    • Uberlândia, Minas Gerais, Brazil, 38411-186
      • Research Site
  • Santa Catarina
    • Blumenau, Santa Catarina, Brazil, 89030-101
      • Research Site
• Canada
  • New Brunswick, Canada, E1G 1A7
    • Research Site
  • Quebec, Canada, G1G 3Y8
    • Research Site
  • Alberta
    • Edmonton, Alberta, Canada, T5A 4L8
      • Research Site
    • Edmonton, Alberta, Canada, T6G 2V2
      • Research Site
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Research Site
  • Ontario
    • Burlington, Ontario, Canada, L7N 3V2
      • Research Site
    • Downsview, Ontario, Canada, M3M 3E5
      • Research Site
    • Fort Erie, Ontario, Canada, 12A 1Z3
      • Research Site
    • Hamilton, Ontario, Canada, L8N 4A6
      • Research Site
    • London, Ontario, Canada, N6A 2C2
      • Research Site
    • Mississauga, Ontario, Canada, L5A 3V4
      • Research Site
    • Oshawa, Ontario, Canada, L1H 7K4
      • Research Site
    • Windsor, Ontario, Canada, N8X 1T3
      • Research Site
    • Windsor, Ontario, Canada, N8X 5A6
      • Research Site
  • Quebec
    • St-Charles-Borromée, Quebec, Canada, J6E 2B4
      • Research Site
• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Research Site
    • Beijing, Beijing, China, 100029
      • Research Site
    • Beijing, Beijing, China, 100144
      • Research Site
  • Chengdu
    • Sichuan, Chengdu, China, 610041
      • Research Site
  • Guangdong
    • Dongguan, Guangdong, China, 511700
      • Research Site
    • Dongguan, Guangdong, China, 523059
      • Research Site
    • Shantou, Guangdong, China, 515041
      • Research Site
    • Shenzhen, Guangdong, China, 518035
      • Research Site
    • Shenzhen, Guangdong, China, 518036
      • Research Site
    • Shenzhen, Guangdong, China, 518053
      • Research Site
  • Guangzhou
    • Guangdong, Guangzhou, China, 510120
      • Research Site
  • Henan
    • Changsha, Henan, China, 410011
      • Research Site
    • Zhengzhou, Henan, China, 450003
      • Research Site
  • Hubei
    • Shiyan, Hubei, China, 442000
      • Research Site
  • Inner Mongolia
    • Baotou, Inner Mongolia, China, 140170
      • Research Site
    • Hohhot, Inner Mongolia, China, 010050
      • Research Site
  • Jiangsu
    • Nanjing, Jiangsu, China, 210006
      • Research Site
    • Suzhou, Jiangsu, China, 215101
      • Research Site
    • Yangzhou, Jiangsu, China, 225007
      • Research Site
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • Research Site
  • Jilin
    • Changchun, Jilin, China, 130021
      • Research Site
    • Yanji, Jilin, China, 133099
      • Research Site
  • Shaanxi
    • Xi'An, Shaanxi, China, 710061
      • Research Site
  • Shandong
    • Jinan, Shandong, China, 250117
      • Research Site
    • Weifang, Shandong, China, 261000
      • Research Site
  • Shanghai
    • Shanghai, Shanghai, China, 430030
      • Research Site
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310013
      • Research Site
    • Jinhua, Zhejiang, China, 321000
      • Research Site
• Colombia
  • Antioquia, Colombia, 50010
    • Research Site
  • Caldas
    • Manizales, Caldas, Colombia, 170004
      • Research Site
  • Cundinamarca
    • Zipaquira, Cundinamarca, Colombia, 250252
      • Research Site
  • Distrito Capital De Bogotá
    • Bogota, Distrito Capital De Bogotá, Colombia, 1004
      • Research Site
    • Bogotá, Distrito Capital De Bogotá, Colombia, 5946175
      • Research Site
    • Bucaramanga, Distrito Capital De Bogotá, Colombia, 681004
      • Research Site
  • Meta
    • Villavicencio, Meta, Colombia, 500001
      • Research Site
• Denmark
  • Central Jutland
    • Aarhus N, Central Jutland, Denmark, 8200
      • Research Site
    • Viby J, Central Jutland, Denmark, 8260
      • Research Site
• France
  • Paris, France, 75014
    • Research Site
  • Aquitaine
    • Pau Cedex, Aquitaine, France, 64046
      • Research Site
  • Auvergne
    • Clermont Ferrand Cedex 1, Auvergne, France, 63003
      • Research Site
  • Bas-Rhin
    • Strasbourg Cedex, Bas-Rhin, France, 67091
      • Research Site
  • Bretagne
    • Brest, Bretagne, France, 29609
      • Research Site
    • Brest cedex, Bretagne, France, 29240
      • Research Site
  • Calvados
    • Caen, Calvados, France, 14000
      • Research Site
  • Côte-d'Or
    • Dijon, Côte-d'Or, France, 21079
      • Research Site
  • Franche-Comté
    • Besancon Cedex, Franche-Comté, France, 25030
      • Research Site
  • Gironde
    • Pessac Cedex, Gironde, France, 33608
      • Research Site
  • Haut-Rhin
    • Mulhouse, Haut-Rhin, France, 68070
      • Research Site
  • Haute-Vienne
    • Limoges, Haute-Vienne, France, 87042
      • Research Site
  • Hautes-Pyrénées
    • Tarbes, Hautes-Pyrénées, France, 65013
      • Research Site
  • Hérault
    • Montpellier, Hérault, France, 34090
      • Research Site
  • Loiret
    • Orléans, Loiret, France, 45067
      • Research Site
  • Meurthe-et-Moselle
    • Nancy, Meurthe-et-Moselle, France, 54100
      • Research Site
  • Nord
    • Bersee, Nord, France, 59235
      • Research Site
    • Lille Cedex, Nord, France, 59037
      • Research Site
  • Provence-Alpes-Côte-d'Azur
    • Aix en Provence, Provence-Alpes-Côte-d'Azur, France, 13616
      • Research Site
  • Pyrénées-Atlantiques
    • Biarritz, Pyrénées-Atlantiques, France, 64200
      • Research Site
  • Rhône
    • Villefranche-sur-Saône, Rhône, France, 69655
      • Research Site
  • Rhône-Alpes
    • Lyon, Rhône-Alpes, France, 69317
      • Research Site
  • Sarthe
    • Le Mans cedex, Sarthe, France, 72037
      • Research Site
  • Seine-Maritime
    • Montvilliers, Seine-Maritime, France, 76290
      • Research Site
    • Rouen Cedex, Seine-Maritime, France, 76031
      • Research Site
  • Val-de-Marne
    • Créteil, Val-de-Marne, France, 94010
      • Research Site
  • Île-de-France
    • Paris, Île-de-France, France, 75015
      • Research Site
• Germany
  • Berlin, Germany, 13187
    • Research Site
  • Berlin, Germany, 10961
    • Research Site
  • Berlin, Germany, 10625
    • Research Site
  • Hamburg, Germany, 20354
    • Research Site
  • Hamburg, Germany, 22767
    • Research Site
  • Hamburg, Germany, 22335
    • Research Site
  • Baden-Württemberg
    • Bruchsal, Baden-Württemberg, Germany, 76646
      • Research Site
    • Heidelberg, Baden-Württemberg, Germany, 69126
      • Research Site
  • Bayern
    • Augsburg, Bayern, Germany, 86150
      • Research Site
    • Munich, Bayern, Germany, 80539
      • Research Site
  • Hessen
    • Marburg, Hessen, Germany, 35037
      • Research Site
  • Niedersachsen
    • Peine, Niedersachsen, Germany, 31224
      • Research Site
  • Nordrhein-Westfalen
    • Ibbenbueren, Nordrhein-Westfalen, Germany, 49477
      • Research Site
    • Ratingen, Nordrhein-Westfalen, Germany, 40878
      • Research Site
  • Saarland
    • Dillingen, Saarland, Germany, 66763
      • Research Site
  • Sachsen
    • Dresden, Sachsen, Germany, 01307
      • Research Site
    • Leipzig, Sachsen, Germany, 04299
      • Research Site
  • Sachsen-Anhalt
    • Halberstadt, Sachsen-Anhalt, Germany, 38820
      • Research Site
  • Schleswig-Holstein
    • Luebeck, Schleswig-Holstein, Germany, 23558
      • Research Site
    • Reinfeld, Schleswig-Holstein, Germany, 23858
      • Research Site
    • Schleswig, Schleswig-Holstein, Germany, 24837
      • Research Site
• Italy
  • Catania, Italy, 95123
    • Research Site
  • Ferrara, Italy, 44121
    • Research Site
  • Firenze, Italy, 50134
    • Research Site
  • Foggia, Italy, 71100
    • Research Site
  • Genova, Italy, 16132
    • Research Site
  • Livorno, Italy, 57124
    • Research Site
  • Messina, Italy, 98123
    • Research Site
  • Modena, Italy, 41124
    • Research Site
  • Napoli, Italy, 80131
    • Research Site
  • Palermo, Italy, 90146
    • Research Site
  • Pordenone, Italy, '33170
    • Research Site
  • Roma, Italy, 00168
    • Research Site
  • Roma, Italy, 00133
    • Research Site
  • Roma, Italy, 00163
    • Research Site
  • Abruzzo
    • Chieti, Abruzzo, Italy, 66100
      • Research Site
  • Lazio
    • Roma, Lazio, Italy, 00168
      • Research Site
  • Lombardia
    • Mantova, Lombardia, Italy, 46100
      • Research Site
  • Marche
    • Torrette Di Ancona, Marche, Italy, 60126
      • Research Site
  • Milano
    • Monza, Milano, Italy, 20900
      • Research Site
  • Pavia
    • Montescano, Pavia, Italy, 27040
      • Research Site
  • Piemonte
    • Orbassano, Piemonte, Italy, 10043
      • Research Site
  • Salerno
    • Torre Del Greco (Napoli), Salerno, Italy, 80049
      • Research Site
  • Sardegna
    • Sassari, Sardegna, Italy, 07100
      • Research Site
  • Sicilia
    • Gravina Di Catania, Sicilia, Italy, 95030
      • Research Site
• Japan
  • Fukuoka, Japan, 815-8588
    • Research Site
  • Fukushima, Japan, 960-1295
    • Research Site
  • Shizuoka, Japan, 420-8527
    • Research Site
  • Toyama, Japan, 930-0194
    • Research Site
  • Yamagata, Japan, 990-9585
    • Research Site
  • Aichi
    • Nagoya, Aichi, Japan, 454-8509
      • Research Site
  • Fukuoka
    • Fukuoka-shi, Fukuoka, Japan, 814-0180
      • Research Site
    • Kitakyushu, Fukuoka, Japan, 802-0077
      • Research Site
    • Kurume, Fukuoka, Japan, 830-0011
      • Research Site
    • Omuta, Fukuoka, Japan, 837-0911
      • Research Site
  • Hyogo
    • Itami, Hyogo, Japan, 664-8540
      • Research Site
    • Kobe, Hyogo, Japan, 650-0047
      • Research Site
  • Ibaraki
    • Higashiibaraki-gun, Ibaraki, Japan, 311-3193
      • Research Site
  • Ishikawa
    • Kanazawa, Ishikawa, Japan, 920-8650
      • Research Site
    • Kanazawa-shi, Ishikawa, Japan, 920-8530
      • Research Site
  • Kanagawa
    • Yokohama, Kanagawa, Japan, 236-0004
      • Research Site
  • Miyagi
    • Ishinomaki, Miyagi, Japan, 986-8522
      • Research Site
  • Osaka
    • Kishiwada, Osaka, Japan, 596-8501
      • Research Site
  • Shimane
    • Matsue, Shimane, Japan, 690-8556
      • Research Site
  • Shizuoka
    • Shizuoka, Shizuoka, Shizuoka, Japan, 420-8630
      • Research Site
  • Tochigi
    • Shimotsuga-gun, Tochigi, Japan, 321-0293
      • Research Site
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 103-0028
      • Research Site
    • Kiyose, Tokyo, Japan, 204-8585
      • Research Site
    • Nakano-ku, Tokyo, Japan, 164-0012
      • Research Site
• Korea, Republic of
  • Daegu Gwang'yeogsi
    • Daegu, Daegu Gwang'yeogsi, Korea, Republic of, 42415
      • Research Site
  • Gang'weondo
    • Chuncheon-Si, Gang'weondo, Korea, Republic of, 24289
      • Research Site
  • Gwangju Gwang'yeogsi
    • Gwangju, Gwangju Gwang'yeogsi, Korea, Republic of, 61469
      • Research Site
  • Gyeonggido
    • Anyang-Si, Gyeonggido, Korea, Republic of, 14068
      • Research Site
    • Gyeonggi-do, Gyeonggido, Korea, Republic of, 04401
      • Research Site
    • Seongnam-Si, Gyeonggido, Korea, Republic of, 13620
      • Research Site
    • Suwon-si, Gyeonggido, Korea, Republic of, 16499
      • Research Site
  • Incheon Gwang'yeogsi
    • Incheon, Incheon Gwang'yeogsi, Korea, Republic of, 21565
      • Research Site
  • Jeonrabugdo
    • Jeonju-Si, Jeonrabugdo, Korea, Republic of, 54907
      • Research Site
  • Seoul Teugbyeolsi
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03080
      • Research Site
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03181
      • Research Site
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 04763
      • Research Site
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 05505
      • Research Site
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06351
      • Research Site
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06591
      • Research Site
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 07345
      • Research Site
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 07985
      • Research Site
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 08308
      • Research Site
• Mexico
  • Mexico, Mexico, 14050
    • Research Site
  • Distrito Federal
    • Mexico, Distrito Federal, Mexico, 06760
      • Research Site
  • Hidalgo
    • Pachuca, Hidalgo, Mexico, 42070
      • Research Site
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44670
      • Research Site
    • Guadalajara, Jalisco, Mexico, 44130
      • Research Site
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64460
      • Research Site
  • Tabasco
    • Villahermosa, Tabasco, Mexico, 86035
      • Research Site
• Netherlands
  • Groningen, Netherlands, 9700 GZ
    • Research Site
  • Gelderland
    • Arnhem, Gelderland, Netherlands, 6815 AD
      • Research Site
    • Nijmegen, Gelderland, Netherlands, 6532 SZ
      • Research Site
    • Zutphen, Gelderland, Netherlands, 7207 AE
      • Research Site
  • Limburg
    • Horn, Limburg, Netherlands, 6085 NM
      • Research Site
  • Noord-Brabant
    • Breda, Noord-Brabant, Netherlands, 4818 CK
      • Research Site
    • Veldhoven, Noord-Brabant, Netherlands, 5604 DB
      • Research Site
  • Noord-Holland
    • Alkmaar, Noord-Holland, Netherlands, 1815 JD
      • Research Site
  • Overijssel
    • Enschede, Overijssel, Netherlands, 7512 KZ
      • Research Site
  • Utrecht
    • Nieuwegein, Utrecht, Netherlands, 3435 CM
      • Research Site
  • Zuid-Holland
    • Rotterdam, Zuid-Holland, Netherlands, 3045 PM
      • Research Site
• Norway
  • Oslo, Norway, 0953
    • Research Site
  • Trondheim, Norway, 7427
    • Research Site
  • Akershus
    • Jassheim, Akershus, Norway, 2067
      • Research Site
    • Lørenskog, Akershus, Norway, 01478
      • Research Site
    • Trollåsen, Akershus, Norway, 1414
      • Research Site
  • Rogaland
    • Tananger, Rogaland, Norway, 4056
      • Research Site
• Spain
  • Badajoz, Spain, 06080
    • Research Site
  • Barcelona, Spain, 08036
    • Research Site
  • Barcelona, Spain, 08023
    • Research Site
  • Burgos, Spain, 09006
    • Research Site
  • Granada, Spain, 18016
    • Research Site
  • Lugo, Spain, 27003
    • Research Site
  • Madrid, Spain, 28031
    • Research Site
  • Madrid, Spain, 28006
    • Research Site
  • Madrid, Spain, 28047
    • Research Site
  • Murcia, Spain, 30120
    • Research Site
  • Murcia, Spain, 30720
    • Research Site
  • Málaga, Spain, 29010
    • Research Site
  • Málaga, Spain, 29009
    • Research Site
  • Valladolid, Spain, 47012
    • Research Site
  • Zaragoza, Spain, 50009
    • Research Site
  • Asturias
    • Oviedo, Asturias, Spain, 33011
      • Research Site
  • Baleares
    • Palma de Mallorca, Baleares, Spain, 07120
      • Research Site
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Research Site
    • Centelles, Barcelona, Spain, 08540
      • Research Site
  • Canarias
    • Sta. Cruz de Tenerife, Canarias, Spain, 38010
      • Research Site
  • Ciudad Real
    • Alcázar de San Juan, Ciudad Real, Spain, 13600
      • Research Site
  • Cádiz
    • Palmones, Cádiz, Spain, 11379
      • Research Site
  • Madrid
    • Alcalá de Henares, Madrid, Spain, 28805
      • Research Site
    • Móstoles, Madrid, Spain, 28933
      • Research Site
    • Pozuelo de Alarcon, Madrid, Spain, 28223
      • Research Site
    • Torrelaguna, Madrid, Spain, 28180
      • Research Site
  • Murcia
    • Cartagena, Murcia, Spain, 30203
      • Research Site
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Research Site
  • Pontevedra
    • Vigo, Pontevedra, Spain, 36312
      • Research Site
    • Vigo, Pontevedra, Spain, 36211
      • Research Site
  • Vizcaya
    • Baracaldo, Vizcaya, Spain, 48903
      • Research Site
• Sweden
  • Jönköpings Län
    • Värnamo, Jönköpings Län, Sweden, 331 85
      • Research Site
  • Skåne Län
    • Lund, Skåne Län, Sweden, 222 22
      • Research Site
  • Stockholms Län
    • Stockholm, Stockholms Län, Sweden, 113 61
      • Research Site
  • Uppsala Län
    • Uppsala, Uppsala Län, Sweden, 751 85
      • Research Site
    • Uppsala, Uppsala Län, Sweden, 752 63
      • Research Site
  • Västra Götalands Län
    • Göteborg, Västra Götalands Län, Sweden, 413 45
      • Research Site
• United Kingdom
  • Birmingham, United Kingdom, B9 5SS
    • Research Site
  • Liverpool, United Kingdom, L7 8XP
    • Research Site
  • Manchester, United Kingdom, M13 9WL
    • Research Site
  • Manchester, United Kingdom, M23 9LT
    • Research Site
  • Newport, United Kingdom, NP20 2UB
    • Research Site
  • Warwickshire, United Kingdom, CV9 1EU
    • Research Site
  • York, United Kingdom, YO24 3WX
    • Research Site
  • Carmarthenshire
    • Swansea, Carmarthenshire, United Kingdom, SA14 8QF
      • Research Site
  • Essex
    • Chelmsford, Essex, United Kingdom, CM1 7ET
      • Research Site
  • Hampshire
    • Southampton, Hampshire, United Kingdom, SO16 6YD
      • Research Site
  • Hertfordshire
    • Watford, Hertfordshire, United Kingdom, WD18 0HB
      • Research Site
  • Kensington And Chelsea
    • Middlesborough, Kensington And Chelsea, United Kingdom, TS4 3BW
      • Research Site
  • Kingston Upon Hull, City Of
    • Hull, Kingston Upon Hull, City Of, United Kingdom, HU16 5JQ
      • Research Site
  • Lancashire
    • Thornton Cleveleys, Lancashire, United Kingdom, FY5 2TZ
      • Research Site
  • London, City Of
    • London, London, City Of, United Kingdom, SW3 6NP
      • Research Site
  • North Lanarkshire
    • Wishaw, North Lanarkshire, United Kingdom, ML20DP
      • Research Site
  • North Yorkshire
    • York, North Yorkshire, United Kingdom, YO1 7NP
      • Research Site
    • York, North Yorkshire, United Kingdom, YO32 2LL
      • Research Site
    • York, North Yorkshire, United Kingdom, YO32 5UA
      • Research Site
  • Northern Ireland
    • Belfast, Northern Ireland, United Kingdom, BT9 7AB
      • Research Site
  • Nottinghamshire
    • Nottingham, Nottinghamshire, United Kingdom, NG51PB
      • Research Site
  • South Tyneside
    • Tyne And Wear, South Tyneside, United Kingdom, NE34 0PL
      • Research Site
  • York
    • Pickering, York, United Kingdom, YO18 8BL
      • Research Site
• United States
  • California
    • Loma Linda, California, United States, 92357
      • Research Site
    • Long Beach, California, United States, 90822
      • Research Site
    • Roseville, California, United States, 95661
      • Research Site
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Research Site
    • Colorado Springs, Colorado, United States, 80907
      • Research Site
  • Florida
    • Clearwater, Florida, United States, 33765-2103
      • Research Site
    • Gainesville, Florida, United States, 32608-1197
      • Research Site
    • Miami, Florida, United States, 33125
      • Research Site
    • Miami, Florida, United States, 33032
      • Research Site
    • Plantation, Florida, United States, 33322
      • Research Site
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Research Site
    • Normal, Illinois, United States, 61761
      • Research Site
  • Kansas
    • Hutchinson, Kansas, United States, 67502
      • Research Site
  • Louisiana
    • Shreveport, Louisiana, United States, 71103
      • Research Site
  • Massachusetts
    • Fall River, Massachusetts, United States, 02720
      • Research Site
  • Michigan
    • Ann Arbor, Michigan, United States, 48106
      • Research Site
    • Buckley, Michigan, United States, 49620
      • Research Site
    • Hamtramck, Michigan, United States, 48212
      • Research Site
  • Nebraska
    • Lincoln, Nebraska, United States, 68505
      • Research Site
  • New Jersey
    • Highland Park, New Jersey, United States, 08904
      • Research Site
    • W. Berlin, New Jersey, United States, 08091
      • Research Site
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • Research Site
  • New York
    • Bronx, New York, United States, 10459
      • Research Site
    • Bronx, New York, United States, 10461
      • Research Site
    • Bronx, New York, United States, 10465
      • Research Site
    • New York, New York, United States, 10016
      • Research Site
    • New York, New York, United States, 10001
      • Research Site
    • Rockville Centre, New York, United States, 11570
      • Research Site
  • North Dakota
    • Fargo, North Dakota, United States, 58104
      • Research Site
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Research Site
    • Kettering, Ohio, United States, 45439
      • Research Site
    • Wooster, Ohio, United States, 44691
      • Research Site
  • Pennsylvania
    • Altoona, Pennsylvania, United States, 16602
      • Research Site
  • Rhode Island
    • Providence, Rhode Island, United States, 02914
      • Research Site
  • Texas
    • Austin, Texas, United States, 78731
      • Research Site
    • Houston, Texas, United States, 77079
      • Research Site
    • Live Oak, Texas, United States, 78233
      • Research Site
    • San Antonio, Texas, United States, 78023
      • Research Site
  • Virginia
    • Richmond, Virginia, United States, 23219
      • Research Site
  • West Virginia
    • Charleston, West Virginia, United States, 25304
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 130 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with suspected or primary diagnosis of asthma and 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.

Description

Inclusion Criteria:

• Diagnosis, or suspected diagnosis, of asthma and/or COPD, according to clinician's judgment
• 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 participated in any respiratory interventional trial during the 12 months prior to enrolment or at enrolment
• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Chronic airways disease; Patients with suspected or primary diagnosis of asthma or COPD	Procedure: Blood draw; Biomarkers analyses; Procedure: Urine; Biomarker analyses; Procedure: Lung function measurements; FEV1, FVC, PEF, FEF25-75%, IC, calculated FEV1/FVC ratio and calculated FEV1 % predicted; Procedure: Fractional Exhaled Nitric Oxide (FENO); Measures level of exhaled nitric oxide.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spirometry - change in Forced Expiratory Volume in 1 second (FEV1) (Litres [L])	Lung function test	Change from baseline FEV1 at Year 1, 2 and 3
Spirometry - change in Forced Vital Capacity (FVC) (L)	Lung function test	Change from baseline FVC at Year 1, 2 and 3
Spirometry - change in Peak Expiratory Flow (PEF) (Litre/second [L/s])	Lung function test	Change from baseline PEF at Year 1, 2 and 3
Spirometry - change in Forced Expiratory Flow at 25-75% of the forced vital capacity (FEF25-75%) (L/s)	Lung function test	Change from baseline FEF25-75% at Year 1, 2 and 3
Spirometry - change in Inspiratory Capacity (IC) (L)	Lung function test	Change from baseline IC at Year 1, 2 and 3
Post-bronchodilator spirometry - FEV1 (L)	Bronchodilator reversibility test	Baseline
Post-bronchodilator spirometry - FVC (L)	Bronchodilator reversibility test	Baseline
Post-bronchodilator spirometry - PEF (L/s)	Bronchodilator reversibility test	Baseline
Post-bronchodilator spirometry - FEF25-75% (L/s)	Bronchodilator reversibility test	Baseline
Post-bronchodilator spirometry - IC (L)	Bronchodilator reversibility test	Baseline
Fractional exhaled nitric oxide (FeNO) (parts per billion [ppb])	Test to measure fractional exhaled nitric oxide (ppb) levels in exhaled breath	Baseline
Change in symptoms/symptom control assessed by the Chronic Airways Assessment Test (CAAT)	Patient reported outcome questionnaire	Change from baseline CAAT scores at Year 1, 2, and 3
Symptoms/symptom control assessed by the modified Medical Research Council (mMRC) scale	Patient reported outcome questionnaire	Baseline
Change in symptoms/symptom control assessed by the Respiratory Symptoms Questionnaire (RSQ)	Patient reported outcome questionnaire	Change from baseline RSQ scores at Year 1, 2 and 3
Change in symptoms/symptom control assessed by the Asthma Control Test (ACT)	Patient reported outcome questionnaire	Change from baseline ACT scores at Year 1, 2 and 3
COPD Foundation Primary Care Tool for Undiagnosed Respiratory Disease and Exacerbation Risk (CAPTURE) - to identify undiagnosed patients with clinically significant COPD	Patient reported outcome questionnaire	Baseline

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: Parexel

Publications and helpful links

General Publications

• 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.

Helpful Links

• NOVELTY_protocol_v1_with_amendment_history_REDACTED
• CSR Synopsis

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2016
• Primary Completion (Actual): May 31, 2023
• Study Completion (Actual): May 31, 2023

Study Registration Dates

• First Submitted: April 5, 2016
• First Submitted That Met QC Criteria: April 30, 2016
• First Posted (Estimated): May 3, 2016

Study Record Updates

• Last Update Posted (Actual): October 3, 2024
• Last Update Submitted That Met QC Criteria: October 2, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: COPD; asthma; lung disease; chronic obstructive pulmonary disease; obstructive lung disease; chronic airways disease
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Disease Attributes; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity; Chronic Disease; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Asthma; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Protective Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Antioxidants; Free Radical Scavengers; Endothelium-Dependent Relaxing Factors; Gasotransmitters; Nitric Oxide
• Other Study ID Numbers: D2287R00103