AsthmaNOVELTYNCT02760329

Observational Study of Obstructive Lung Disease (NOVELTY)

An observational study of Asthma and COPD, run by AstraZeneca at 331 sites in 19 countries.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 12 to 130 years
Conditions the study is for: Asthma, COPD, Chronic Obstructive Pulmonary Disease
What is being tested?: Blood draw, Urine and Lung function measurements
Type of treatment: Surgery or procedure
How many people: 12,255 participants
Where: 331 sitesin 19 countries
Study dates: 25 Jul 2016to 31 May 2023
Phase: Observational
Are there results?: None posted in the registry

Key requirements

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

Ages 12 to 130 years
All sexes
No healthy volunteers
Child, Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

331 sites in 19 countries.

Country

City, postcode or hospital

331 sites in 19 countries

United States40 sites

Research Site
Albuquerque, New Mexico, 87109
Research Site
Altoona, Pennsylvania, 16602
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Ann Arbor, Michigan, 48106
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Aurora, Colorado, 80045
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Austin, Texas, 78731
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Buckley, Michigan, 49620
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Charleston, West Virginia, 25304
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Chicago, Illinois, 60612
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Cincinnati, Ohio, 45242
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Clearwater, Florida, 33765-2103
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Colorado Springs, Colorado, 80907
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Fall River, Massachusetts, 02720
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Fargo, North Dakota, 58104
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Gainesville, Florida, 32608-1197
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Hamtramck, Michigan, 48212
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Highland Park, New Jersey, 08904
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Houston, Texas, 77079
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Hutchinson, Kansas, 67502
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Kettering, Ohio, 45439
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Lincoln, Nebraska, 68505
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Live Oak, Texas, 78233
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Loma Linda, California, 92357
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Long Beach, California, 90822
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Miami, Florida, 33032
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Miami, Florida, 33125
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New York, New York, 10001
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New York, New York, 10016
Research Site
Normal, Illinois, 61761
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Plantation, Florida, 33322
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Providence, Rhode Island, 02914
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Richmond, Virginia, 23219
Research Site
Rockville Centre, New York, 11570
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Roseville, California, 95661
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San Antonio, Texas, 78023
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Shreveport, Louisiana, 71103
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The Bronx, New York, 10459
Research Site
The Bronx, New York, 10461
Research Site
The Bronx, New York, 10465
Research Site
West Berlin, New Jersey, 08091
Research Site
Wooster, Ohio, 44691

Other trials in United States

Spain31 sites

Research Site
Alcalá de Henares, Madrid, 28805
Research Site
Alcázar de San Juan, Ciudad Real, 13600
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Badajoz, 06080
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Badalona, Barcelona, 08916
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Barakaldo, Vizcaya, 48903
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Barcelona, 08023
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Barcelona, 08036
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Burgos, 09006
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Cartagena, Murcia, 30203
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Centelles, Barcelona, 08540
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Granada, 18016
Research Site
Lugo, 27003
Research Site
Madrid, 28006
Research Site
Madrid, 28031
Research Site
Madrid, 28047
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Málaga, 29009
Research Site
Málaga, 29010
Research Site
Móstoles, Madrid, 28933
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Murcia, 30120
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Murcia, 30720
Research Site
Oviedo, Principality of Asturias, 33011
Research Site
Palma de Mallorca, Balearic Islands, 07120
Research Site
Palmones, Cádiz, 11379
Research Site
Pamplona, Navarre, 31008
Research Site
Pozuelo de Alarcón, Madrid, 28223
Research Site
Santa Cruz de Tenerife, Canary Islands, 38010
Research Site
Torrelaguna, Madrid, 28180
Research Site
Valladolid, 47012
Research Site
Vigo, Pontevedra, 36211
Research Site
Vigo, Pontevedra, 36312
Research Site
Zaragoza, 50009

Other trials in Spain

China28 sites

Research Site
Baotou, Inner Mongolia, 140170
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Beijing, Beijing Municipality, 100029
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Beijing, Beijing Municipality, 100144
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Beijing, Beijing Municipality, 100730
Research Site
Changchun, Jilin, 130021
Research Site
Changshacun, Henan, 410011
Research Site
Dongguan, Guangdong, 511700
Research Site
Dongguan, Guangdong, 523059
Research Site
Guangdong, Guangzhou, 510120
Research Site
Hangzhou, Zhejiang, 310013
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Hohhot, Inner Mongolia, 010050
Research Site
Jinan, Shandong, 250117
Research Site
Jinhua, Zhejiang, 321000
Research Site
Nanchang, Jiangxi, 330006
Research Site
Nanjing, Jiangsu, 210006
Research Site
Shanghai, Shanghai Municipality, 430030
Research Site
Shantou, Guangdong, 515041
Research Site
Shenzhen, Guangdong, 518035
Research Site
Shenzhen, Guangdong, 518036
Research Site
Shenzhen, Guangdong, 518053
Research Site
Shiyan, Hubei, 442000
Research Site
Sichuan, Chengdu, 610041
Research Site
Suzhou, Jiangsu, 215101
Research Site
Weifang, Shandong, 261000
Research Site
Xi'an, Shaanxi, 710061
Research Site
Yangzhou, Jiangsu, 225007
Research Site
Yanji, Jilin, 133099
Research Site
Zhengzhou, Henan, 450003

Other trials in China

France27 sites

Research Site
Aix-en-Provence, Provence-Alpes-Côte d'Azur Region, 13616
Research Site
Bersée, Nord, 59235
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Besançon, Franche-Comté, 25030
Research Site
Biarritz, Pyrénées-Atlantiques, 64200
Research Site
Brest, Brittany Region, 29240
Research Site
Brest, Brittany Region, 29609
Research Site
Caen, Calvados, 14000
Research Site
Clermont-Ferrand, Auvergne, 63003
Research Site
Créteil, Val-de-Marne, 94010
Research Site
Dijon, Côte-d'Or, 21079
Research Site
Le Mans, Sarthe, 72037
Research Site
Lille, Nord, 59037
Research Site
Limoges, Haute-Vienne, 87042
Research Site
Lyon, Auvergne-Rhône-Alpes, 69317
Research Site
Montpellier, Hérault, 34090
Research Site
Montvilliers, Seine-Maritime, 76290
Research Site
Mulhouse, Haut-Rhin, 68070
Research Site
Nancy, Meurthe-et-Moselle, 54100
Research Site
Orléans, Loiret, 45067
Research Site
Paris, 75014
Research Site
Paris, Île-de-France Region, 75015
Research Site
Pau, Aquitaine, 64046
Research Site
Pessac, Gironde, 33608
Research Site
Rouen, Seine-Maritime, 76031
Research Site
Strasbourg, Bas-Rhin, 67091
Research Site
Tarbes, Hautes-Pyrénées, 65013
Research Site
Villefranche-sur-Saône, Rhône, 69655

Other trials in France

Italy24 sites

Research Site
Catania, 95123
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Chieti, Abruzzo, 66100
Research Site
Ferrara, 44121
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Florence, 50134
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Foggia, 71100
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Genova, 16132
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Gravina di Catania, Sicily, 95030
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Livorno, 57124
Research Site
Mantua, Lombardy, 46100
Research Site
Messina, 98123
Research Site
Modena, 41124
Research Site
Montescano, Pavia, 27040
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Monza, Milano, 20900
Research Site
Naples, 80131
Research Site
Orbassano, Piedmont, 10043
Research Site
Palermo, 90146
Research Site
Pordenone, '33170
Research Site
Roma, 00133
Research Site
Roma, 00163
Research Site
Roma, 00168
Research Site
Rome, Lazio, 00168
Research Site
Sassari, Sardinia, 07100
Research Site
Torre Del Greco (Napoli), Salerno, 80049
Research Site
Torrette Di Ancona, The Marches, 60126

Other trials in Italy

Japan24 sites

Research Site
Chuo-ku, Tokyo, 103-0028
Research Site
Fukuoka, Fukuoka, 814-0180
Research Site
Fukuoka, 815-8588
Research Site
Fukushima, 960-1295
Research Site
Higashiibaraki-gun, Ibaraki, 311-3193
Research Site
Ishinomaki, Miyagi, 986-8522
Research Site
Itami, Hyōgo, 664-8540
Research Site
Kanazawa, Ishikawa-ken, 920-8530
Research Site
Kanazawa, Ishikawa-ken, 920-8650
Research Site
Kishiwada, Osaka, 596-8501
Research Site
Kitakyushu, Fukuoka, 802-0077
Research Site
Kiyose, Tokyo, 204-8585
Research Site
Kobe, Hyōgo, 650-0047
Research Site
Kurume, Fukuoka, 830-0011
Research Site
Matsue, Shimane, 690-8556
Research Site
Nagoya, Aichi-ken, 454-8509
Research Site
Nakano-ku, Tokyo, 164-0012
Research Site
Omuta, Fukuoka, 837-0911
Research Site
Shimotsuga-gun, Tochigi, 321-0293
Research Site
Shizuoka, 420-8527
Research Site
Shizuoka, Shizuoka, Shizuoka, 420-8630
Research Site
Toyama, 930-0194
Research Site
Yamagata, 990-9585
Research Site
Yokohama, Kanagawa, 236-0004

Other trials in Japan

United Kingdom23 sites

Research Site
Belfast, Northern Ireland, BT9 7AB
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Birmingham, B9 5SS
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Chelmsford, Essex, CM1 7ET
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Hull, Kingston Upon Hull, City of, HU16 5JQ
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Liverpool, L7 8XP
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London, London, City of, SW3 6NP
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Manchester, M13 9WL
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Manchester, M23 9LT
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Middlesbrough, Kensington and Chelsea, TS4 3BW
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Newport, NP20 2UB
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Nottingham, Nottinghamshire, NG51PB
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Pickering, York, YO18 8BL
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Southampton, Hampshire, SO16 6YD
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Swansea, Carmarthenshire, SA14 8QF
Research Site
Thornton-Cleveleys, Lancashire, FY5 2TZ
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Tyne and Wear, South Tyneside, NE34 0PL
Research Site
Warwickshire, Warwickshire, CV9 1EU
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Watford, Hertfordshire, WD18 0HB
Research Site
Wishaw, North Lanarkshire, ML20DP
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York, North Yorkshire, YO1 7NP
Research Site
York, North Yorkshire, YO32 2LL
Research Site
York, North Yorkshire, YO32 5UA
Research Site
York, YO24 3WX

Other trials in United Kingdom

Australia22 sites

Research Site
Bedford Park, South Australia, 5042
Research Site
Blacktown, New South Wales, 2148
Research Site
Brisbane, Queensland, 4102
Research Site
Camperdown, New South Wales, 2050
Research Site
Coffs Harbour, New South Wales, 2450
Research Site
Concord, New South Wales, 2139
Research Site
Crawley, Western Australia, 6009
Research Site
Frankston, Victoria, 3199
Research Site
Happy Valley, South Australia, 5159
Research Site
Kanwal, New South Wales, 2259
Research Site
Kingswood, New South Wales, 2747
Research Site
Liverpool, New South Wales, 2170
Research Site
Miranda, New South Wales, 2228
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New Lambton, New South Wales, 2305
Research Site
Parkville, Victoria, 3050
Research Site
Randwick, New South Wales, 2031
Research Site
Redcliffe, Queensland, 4020
Research Site
Sedney, New South Wales, 2109
Research Site
South Brisbane, Queensland, 4101
Research Site
Spearwood, Western Australia, 6163
Research Site
Wamberal, New South Wales, 2260
Research Site
Woodville South, South Australia, 5011

Other trials in Australia

Germany21 sites

Research Site
Augsburg, Bavaria, 86150
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Berlin, 10625
Research Site
Berlin, 10961
Research Site
Berlin, 13187
Research Site
Bruchsal, Baden-Wurttemberg, 76646
Research Site
Dillingen, Saarland, 66763
Research Site
Dresden, Saxony, 01307
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Halberstadt, Saxony-Anhalt, 38820
Research Site
Hamburg, 20354
Research Site
Hamburg, 22335
Research Site
Hamburg, 22767
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Heidelberg, Baden-Wurttemberg, 69126
Research Site
Ibbenbueren, North Rhine-Westphalia, 49477
Research Site
Leipzig, Saxony, 04299
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Lübeck, Schleswig-Holstein, 23558
Research Site
Marburg, Hesse, 35037
Research Site
Munich, Bavaria, 80539
Research Site
Peine, Lower Saxony, 31224
Research Site
Ratingen, North Rhine-Westphalia, 40878
Research Site
Reinfeld, Schleswig-Holstein, 23858
Research Site
Schleswig, Schleswig-Holstein, 24837

Other trials in Germany

South Korea18 sites

Research Site
Anyang-si, Gyeonggido, 14068
Research Site
Chuncheon, Gang'weondo, 24289
Research Site
Daegu, Daegu Gwang'yeogsi, 42415
Research Site
Gwangju, Gwangju Gwang'yeogsi, 61469
Research Site
Gyeonggi-do, Gyeonggido, 04401
Research Site
Incheon, Incheon Gwang'yeogsi, 21565
Research Site
Jeonju, Jeonrabugdo, 54907
Research Site
Seongnam-si, Gyeonggido, 13620
Research Site
Seoul, Seoul Teugbyeolsi, 03080
Research Site
Seoul, Seoul Teugbyeolsi, 03181
Research Site
Seoul, Seoul Teugbyeolsi, 04763
Research Site
Seoul, Seoul Teugbyeolsi, 05505
Research Site
Seoul, Seoul Teugbyeolsi, 06351
Research Site
Seoul, Seoul Teugbyeolsi, 06591
Research Site
Seoul, Seoul Teugbyeolsi, 07345
Research Site
Seoul, Seoul Teugbyeolsi, 07985
Research Site
Seoul, Seoul Teugbyeolsi, 08308
Research Site
Suwon, Gyeonggido, 16499

Other trials in South Korea

Canada15 sites

Research Site
Burlington, Ontario, L7N 3V2
Research Site
Downsview, Ontario, M3M 3E5
Research Site
Edmonton, Alberta, T5A 4L8
Research Site
Edmonton, Alberta, T6G 2V2
Research Site
Fort Erie, Ontario, 12A 1Z3
Research Site
Hamilton, Ontario, L8N 4A6
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London, Ontario, N6A 2C2
Research Site
Mississauga, Ontario, L5A 3V4
Research Site
New Brunswick, New Brunswick, E1G 1A7
Research Site
Oshawa, Ontario, L1H 7K4
Research Site
Québec, G1G 3Y8
Research Site
Saint-Charles-Borromée, Quebec, J6E 2B4
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Vancouver, British Columbia, V5Z 1M9
Research Site
Windsor, Ontario, N8X 1T3
Research Site
Windsor, Ontario, N8X 5A6

Other trials in Canada

Argentina14 sites

Research Site
Buenos Aires, Buenos Aires F.D., C1121ABE
Research Site
Buenos Aires, Buenos Aires F.D., C1431FWO
Research Site
Buenos Aires, 1015
Research Site
Buenos Aires, C1028AAP
Research Site
Buenos Aires, C1181ACH
Research Site
Buenos Aires, C1425BEN
Research Site
Concepción del Uruguay, Entre Ríos Province, 3260
Research Site
Córdoba, 5000
Research Site
Mendoza, 5500
Research Site
Monte Grande, Buenos Aires, 1842
Research Site
Pilar, Buenos Aires, 1629
Research Site
San Miguel de Tucumán, Tucumán Province, 4000
Research Site
San Salvador, Entre Ríos Province, E3218
Research Site
Tandil, Buenos Aires, 7000

Other trials in Argentina

Netherlands11 sites

Research Site
Alkmaar, North Holland, 1815 JD
Research Site
Arnhem, Gelderland, 6815 AD
Research Site
Breda, North Brabant, 4818 CK
Research Site
Enschede, Overijssel, 7512 KZ
Research Site
Groningen, 9700 GZ
Research Site
Horn, Limburg, 6085 NM
Research Site
Nieuwegein, Utrecht, 3435 CM
Research Site
Nijmegen, Gelderland, 6532 SZ
Research Site
Rotterdam, South Holland, 3045 PM
Research Site
Veldhoven, North Brabant, 5604 DB
Research Site
Zutphen, Gelderland, 7207 AE

Other trials in Netherlands

Colombia7 sites

Research Site
Antioquia, 50010
Research Site
Bogotá, Bogota D.C., 1004
Research Site
Bogotá, Bogota D.C., 5946175
Research Site
Bucaramanga, Bogota D.C., 681004
Research Site
Manizales, Caldas Department, 170004
Research Site
Villavicencio, Meta Department, 500001
Research Site
Zipaquirá, Cundinamarca, 250252

Other trials in Colombia

Mexico7 sites

Research Site
Guadalajara, Jalisco, 44130
Research Site
Guadalajara, Jalisco, 44670
Research Site
México, 14050
Research Site
Mexico City, Mexico City, 06760
Research Site
Monterrey, Nuevo León, 64460
Research Site
Pachuca, Hidalgo, 42070
Research Site
Villahermosa, Tabasco, 86035

Other trials in Mexico

Norway6 sites

Research Site
Jassheim, Akershus, 2067
Research Site
Lørenskog, Akershus, 01478
Research Site
Oslo, 0953
Research Site
Tananger, Rogaland, 4056
Research Site
Trollåsen, Akershus, 1414
Research Site
Trondheim, 7427

Other trials in Norway

Sweden6 sites

Research Site
Gothenburg, Västra Götaland County, 413 45
Research Site
Lund, Skåne County, 222 22
Research Site
Stockholm, Stockholm County, 113 61
Research Site
Uppsala, Uppsala County, 751 85
Research Site
Uppsala, Uppsala County, 752 63
Research Site
Värnamo, Jönköping County, 331 85

Other trials in Sweden

Brazil5 sites

Research Site
Blumenau, Santa Catarina, 89030-101
Research Site
Goiânia, Goiás, 74110 - 030
Research Site
Rio de Janeiro, 21941-913
Research Site
São Paulo, 01221-020
Research Site
Uberlândia, Minas Gerais, 38411-186

Other trials in Brazil

Denmark2 sites

Research Site
Aarhus N, Central Jutland, 8200
Research Site
Viby J, Central Jutland, 8260

Other trials in Denmark

About this study

Official title: 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.

Read the 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.

Conditions: Asthma, COPD, Chronic Obstructive Pulmonary Disease
Being tested: Blood draw, Urine, Lung function measurements, Fractional Exhaled Nitric Oxide (FENO)
Keywords: asthma, COPD, chronic obstructive pulmonary disease, lung disease, chronic airways disease, obstructive lung disease
Medical subject headings: Asthma, Pulmonary Disease, Chronic Obstructive, Lung Diseases, Lung Diseases, Obstructive

What participants receive

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

Blood drawProcedure or surgery
Biomarkers analyses
UrineProcedure or surgery
Biomarker analyses
Lung function measurementsProcedure or surgery
FEV1, FVC, PEF, FEF25-75%, IC, calculated FEV1/FVC ratio and calculated FEV1 % predicted
Fractional Exhaled Nitric Oxide (FENO)Procedure or surgery
Measures level of exhaled nitric oxide.

Study groups in NCT02760329
Study group	Role	What they receive
Chronic airways disease		Patients with suspected or primary diagnosis of asthma or COPD Receives: Procedure: Blood draw; Procedure: Urine; Procedure: Lung function measurements; Procedure: Fractional Exhaled Nitric Oxide (FENO)

What is being measured

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

Spirometry - change in Forced Expiratory Volume in 1 second (FEV1) (Litres [L])
Lung function test
Measured: Change from baseline FEV1 at Year 1, 2 and 3
Spirometry - change in Forced Vital Capacity (FVC) (L)
Lung function test
Measured: Change from baseline FVC at Year 1, 2 and 3
Spirometry - change in Peak Expiratory Flow (PEF) (Litre/second [L/s])
Lung function test
Measured: 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
Measured: Change from baseline FEF25-75% at Year 1, 2 and 3
Spirometry - change in Inspiratory Capacity (IC) (L)
Lung function test
Measured: Change from baseline IC at Year 1, 2 and 3
Post-bronchodilator spirometry - FEV1 (L)
Bronchodilator reversibility test
Measured: Baseline
Post-bronchodilator spirometry - FVC (L)
Bronchodilator reversibility test
Measured: Baseline
Post-bronchodilator spirometry - PEF (L/s)
Bronchodilator reversibility test
Measured: Baseline
Post-bronchodilator spirometry - FEF25-75% (L/s)
Bronchodilator reversibility test
Measured: Baseline
Post-bronchodilator spirometry - IC (L)
Bronchodilator reversibility test
Measured: Baseline
Fractional exhaled nitric oxide (FeNO) (parts per billion [ppb])
Test to measure fractional exhaled nitric oxide (ppb) levels in exhaled breath
Measured: Baseline
Change in symptoms/symptom control assessed by the Chronic Airways Assessment Test (CAAT)
Patient reported outcome questionnaire
Measured: 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
Measured: Baseline
Change in symptoms/symptom control assessed by the Respiratory Symptoms Questionnaire (RSQ)
Patient reported outcome questionnaire
Measured: 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
Measured: 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
Measured: Baseline

Timeline

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

25 Jul 201631 May 2023

First posted3 May 2016 (estimated)
Study start25 Jul 2016
Primary completion31 May 2023
Study completion31 May 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (13)Papers the sponsor has linked to this study.
Other trials for AsthmaStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

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

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 12,255 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02760329
Sponsor's protocol ID: D2287R00103
Acronym: NOVELTY
Status last verified: Oct 2024
First submitted: 5 Apr 2016
Last updated: 3 Oct 2024
Results posted: No
Data monitoring committee: No

Publications

Janson C, Malinovschi A, Borres M, Faner R, Hughes R, Mangelis A, Ma X, Mullerova H, Papi A, Reddel H, Olaguibel JM. Allergic sensitization in asthma and COPD in the NOVELTY study. Respir Med. 2026 Jan;251:108605. doi: 10.1016/j.rmed.2025.108605. Epub 2025 Dec 23.
PubMed 41448282
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 a cohort of adults with asthma and/or chronic obstructive pulmonary disease. Ann Am Thorac Soc. 2026 Feb 1;23(2):188-199. doi: 10.1513/AnnalsATS.202412-1273OC.
PubMed 40961358
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.
PubMed 38841799
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.
PubMed 38348246
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.
PubMed 38141721
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.
PubMed 37334017
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.
PubMed 37230383
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.
PubMed 37031164
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.
PubMed 37020837
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.
PubMed 35820227
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.
PubMed 33632799
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.
PubMed 33569501
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.
PubMed 30723727

Want to know more?

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

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

Questions to ask the study team

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

See locations

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All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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.
ClinicalTrials.gov ID: NCT02760329
Acronym / sponsor ID: NOVELTY / D2287R00103
Conditions: Asthma, COPD, Chronic Obstructive Pulmonary Disease
Keywords: asthma, COPD, chronic obstructive pulmonary disease, lung disease, chronic airways disease, obstructive lung disease
Study type: Observational
Recruitment status: Completed
Enrolment: 12,255 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Parexel
Study start: 25 Jul 2016 (actual)
Primary completion: 31 May 2023 (actual)
Study completion: 31 May 2023 (actual)
First posted: 3 May 2016 (estimated)
Results: Not posted in the source record

Clinical summary

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

Detailed description

Exposure(s):

Sample Size Estimations:

Statistical Analysis:

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.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Chronic airways disease	–	Procedure: Blood draw, Procedure: Urine, Procedure: Lung function measurements, Procedure: Fractional Exhaled Nitric Oxide (FENO)Patients with suspected or primary diagnosis of asthma or COPD

Who may qualify

Ages: 12 to 130 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
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.

Key inclusion criteria (4 listed)

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

Key exclusion criteria (6 listed)

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

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

Interventions

Intervention	Type	Arms
Blood drawBiomarkers analyses	Procedure or surgery	Chronic airways disease
UrineBiomarker analyses	Procedure or surgery	Chronic airways disease
Lung function measurementsFEV1, FVC, PEF, FEF25-75%, IC, calculated FEV1/FVC ratio and calculated FEV1 % predicted	Procedure or surgery	Chronic airways disease
Fractional Exhaled Nitric Oxide (FENO)Measures level of exhaled nitric oxide.	Procedure or surgery	Chronic airways disease

Primary outcome

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
Derived from this study: PubMed 41448282Janson C, Malinovschi A, Borres M, Faner R, Hughes R, Mangelis A, Ma X, Mullerova H, Papi A, Reddel H, Olaguibel JM. Allergic sensitization in asthma and COPD in the NOVELTY study. Respir Med. 2026 Jan;251:108605. doi: 10.1016/j.rmed.2025.108605. Epub 2025 Dec 23.
Derived from this study: PubMed 40961358Beasley 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 a cohort of adults with asthma and/or chronic obstructive pulmonary disease. Ann Am Thorac Soc. 2026 Feb 1;23(2):188-199. doi: 10.1513/AnnalsATS.202412-1273OC.
Derived from this study: PubMed 38841799Papi 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.
Derived from this study: PubMed 38348246Agusti 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.
Derived from this study: PubMed 38141721Ding 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.
Derived from this study: PubMed 37334017Ding 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.
Derived from this study: PubMed 37230383Hughes 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.
Derived from this study: PubMed 37031164Tomaszewski 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.
Derived from this study: PubMed 37020837Marshall 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.
Derived from this study: PubMed 35820227Hughes 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.
Derived from this study: PubMed 33632799Reddel 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.
Derived from this study: PubMed 33569501Karlsson 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.
NOVELTY\_protocol\_v1\_with\_amendment\_history\_REDACTEDLink provided by the sponsor.
CSR SynopsisLink provided by the sponsor.

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Referral and contact

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

The record lists no contact. Use the official record to reach the sponsor.

331 sites in 19 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Asthma and COPD, run by AstraZeneca at 331 sites in 19 countries.

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

Who may be eligible to take part?

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

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 331 sites in United States, Spain, China, France, Italy and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

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

What does the primary outcome measure?

Spirometry - change in Forced Expiratory Volume in 1 second (FEV1) (Litres [L]) (time frame: Change from baseline FEV1 at Year 1, 2 and 3). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02760329, which also lists 13 linked publications.

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

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

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2024.