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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02760329




Registration number
NCT02760329
Ethics application status
Date submitted
5/04/2016
Date registered
3/05/2016
Date last updated
27/06/2023

Titles & IDs
Public title
Observational Study of Obstructive Lung Disease (NOVELTY)
Scientific 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.
Secondary ID [1] 0 0
D2287R00103
Universal Trial Number (UTN)
Trial acronym
NOVELTY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 0 0
COPD 0 0
Chronic Obstructive Pulmonary Disease 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Asthma
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Surgery - Blood draw
Treatment: Surgery - Urine
Treatment: Surgery - Lung function measurements
Treatment: Surgery - Fractional Exhaled Nitric Oxide (FENO)

Chronic airways disease - Patients with suspected or primary diagnosis of asthma or COPD


Treatment: Surgery: Blood draw
Biomarkers analyses

Treatment: Surgery: Urine
Biomarker analyses

Treatment: Surgery: Lung function measurements
FEV1, FVC, PEF, FEF25-75%, IC, calculated FEV1/FVC ratio and calculated FEV1 % predicted

Treatment: Surgery: Fractional Exhaled Nitric Oxide (FENO)
Measures level of exhaled nitric oxide.
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Spirometry - change in Forced Expiratory Volume in 1 second (FEV1) (Litres [L])
Timepoint [1] 0 0
Change from baseline FEV1 at Year 1, 2 and 3
Primary outcome [2] 0 0
Spirometry - change in Forced Vital Capacity (FVC) (L)
Timepoint [2] 0 0
Change from baseline FVC at Year 1, 2 and 3
Primary outcome [3] 0 0
Spirometry - change in Peak Expiratory Flow (PEF) (Litre/second [L/s])
Timepoint [3] 0 0
Change from baseline PEF at Year 1, 2 and 3
Primary outcome [4] 0 0
Spirometry - change in Forced Expiratory Flow at 25-75% of the forced vital capacity (FEF25-75%) (L/s)
Timepoint [4] 0 0
Change from baseline FEF25-75% at Year 1, 2 and 3
Primary outcome [5] 0 0
Spirometry - change in Inspiratory Capacity (IC) (L)
Timepoint [5] 0 0
Change from baseline IC at Year 1, 2 and 3
Primary outcome [6] 0 0
Post-bronchodilator spirometry - FEV1 (L)
Timepoint [6] 0 0
Baseline
Primary outcome [7] 0 0
Post-bronchodilator spirometry - FVC (L)
Timepoint [7] 0 0
Baseline
Primary outcome [8] 0 0
Post-bronchodilator spirometry - PEF (L/s)
Timepoint [8] 0 0
Baseline
Primary outcome [9] 0 0
Post-bronchodilator spirometry - FEF25-75% (L/s)
Timepoint [9] 0 0
Baseline
Primary outcome [10] 0 0
Post-bronchodilator spirometry - IC (L)
Timepoint [10] 0 0
Baseline
Primary outcome [11] 0 0
Fractional exhaled nitric oxide (FeNO) (parts per billion [ppb])
Timepoint [11] 0 0
Baseline
Primary outcome [12] 0 0
Change in symptoms/symptom control assessed by the Chronic Airways Assessment Test (CAAT)
Timepoint [12] 0 0
Change from baseline CAAT scores at Year 1, 2, and 3
Primary outcome [13] 0 0
Symptoms/symptom control assessed by the modified Medical Research Council (mMRC) scale
Timepoint [13] 0 0
Baseline
Primary outcome [14] 0 0
Change in symptoms/symptom control assessed by the Respiratory Symptoms Questionnaire (RSQ)
Timepoint [14] 0 0
Change from baseline RSQ scores at Year 1, 2 and 3
Primary outcome [15] 0 0
Change in symptoms/symptom control assessed by the Asthma Control Test (ACT)
Timepoint [15] 0 0
Change from baseline ACT scores at Year 1, 2 and 3
Primary outcome [16] 0 0
COPD Foundation Primary Care Tool for Undiagnosed Respiratory Disease and Exacerbation Risk (CAPTURE) - to identify undiagnosed patients with clinically significant COPD
Timepoint [16] 0 0
Baseline

Eligibility
Key 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
Minimum age
12 Years
Maximum age
130 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/07/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/05/2023
Sample size
Target
Accrual to date
Final
12257
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Research Site - Blacktown
Recruitment hospital [2] 0 0
Research Site - Camperdown
Recruitment hospital [3] 0 0
Research Site - Coffs Harbour
Recruitment hospital [4] 0 0
Research Site - Concord
Recruitment hospital [5] 0 0
Research Site - Kanwal
Recruitment hospital [6] 0 0
Research Site - Kingswood
Recruitment hospital [7] 0 0
Research Site - Liverpool
Recruitment hospital [8] 0 0
Research Site - Miranda
Recruitment hospital [9] 0 0
Research Site - New Lambton
Recruitment hospital [10] 0 0
Research Site - Randwick
Recruitment hospital [11] 0 0
Research Site - Sedney
Recruitment hospital [12] 0 0
Research Site - Wamberal
Recruitment hospital [13] 0 0
Research Site - Brisbane
Recruitment hospital [14] 0 0
Research Site - Redcliffe
Recruitment hospital [15] 0 0
Research Site - South Brisbane
Recruitment hospital [16] 0 0
Research Site - Bedford Park
Recruitment hospital [17] 0 0
Research Site - Happy Valley
Recruitment hospital [18] 0 0
Research Site - Woodville South
Recruitment hospital [19] 0 0
Research Site - Frankston
Recruitment hospital [20] 0 0
Research Site - Parkville
Recruitment hospital [21] 0 0
Research Site - Crawley
Recruitment hospital [22] 0 0
Research Site - Spearwood
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [4] 0 0
2139 - Concord
Recruitment postcode(s) [5] 0 0
2259 - Kanwal
Recruitment postcode(s) [6] 0 0
2747 - Kingswood
Recruitment postcode(s) [7] 0 0
2170 - Liverpool
Recruitment postcode(s) [8] 0 0
2228 - Miranda
Recruitment postcode(s) [9] 0 0
2305 - New Lambton
Recruitment postcode(s) [10] 0 0
2031 - Randwick
Recruitment postcode(s) [11] 0 0
2109 - Sedney
Recruitment postcode(s) [12] 0 0
2260 - Wamberal
Recruitment postcode(s) [13] 0 0
4102 - Brisbane
Recruitment postcode(s) [14] 0 0
4020 - Redcliffe
Recruitment postcode(s) [15] 0 0
4101 - South Brisbane
Recruitment postcode(s) [16] 0 0
5042 - Bedford Park
Recruitment postcode(s) [17] 0 0
5159 - Happy Valley
Recruitment postcode(s) [18] 0 0
5011 - Woodville South
Recruitment postcode(s) [19] 0 0
3199 - Frankston
Recruitment postcode(s) [20] 0 0
3050 - Parkville
Recruitment postcode(s) [21] 0 0
6009 - Crawley
Recruitment postcode(s) [22] 0 0
6163 - Spearwood
Recruitment outside Australia
Country [1] 0 0
United States of America
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California
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Colorado
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Florida
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Illinois
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Kansas
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Louisiana
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Massachusetts
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Michigan
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Nebraska
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New Jersey
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New Mexico
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New York
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North Dakota
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Ohio
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Pennsylvania
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Rhode Island
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Texas
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United States of America
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Virginia
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West Virginia
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Argentina
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Buenos Aires
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Argentina
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Ciudad Autónoma De Buenos Aires
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Argentina
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Entre Ríos
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Argentina
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Tucumán
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Argentina
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Córdoba
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Argentina
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Mendoza
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Brazil
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Goiás
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Brazil
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Minas Gerais
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Brazil
State/province [28] 0 0
Santa Catarina
Country [29] 0 0
Brazil
State/province [29] 0 0
Rio de Janeiro
Country [30] 0 0
Brazil
State/province [30] 0 0
São Paulo
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Ontario
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Quebec
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New Brunswick
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Beijing
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Chengdu
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Guangzhou
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China
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Henan
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Hubei
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China
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Inner Mongolia
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China
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China
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China
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Jilin
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Shaanxi
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China
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Shandong
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China
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China
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Zhejiang
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Colombia
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Distrito Capital De Bogotá
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Colombia
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Meta
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Colombia
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Antioquia
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Denmark
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Central Jutland
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France
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Aquitaine
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Bretagne
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Calvados
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Côte-d'Or
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Gironde
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Haut-Rhin
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France
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Hautes-Pyrénées
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Hérault
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Loiret
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France
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Meurthe-et-Moselle
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France
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Nord
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France
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Provence-Alpes-Côte-d'Azur
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France
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Pyrénées-Atlantiques
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France
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Rhône-Alpes
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France
State/province [74] 0 0
Rhône
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France
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Sarthe
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Seine-Maritime
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France
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Val-de-Marne
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France
State/province [78] 0 0
Paris
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France
State/province [79] 0 0
Île-de-France
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Germany
State/province [80] 0 0
Baden-Württemberg
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Germany
State/province [81] 0 0
Bayern
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Germany
State/province [82] 0 0
Hessen
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Germany
State/province [83] 0 0
Niedersachsen
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Germany
State/province [84] 0 0
Nordrhein-Westfalen
Country [85] 0 0
Germany
State/province [85] 0 0
Saarland
Country [86] 0 0
Germany
State/province [86] 0 0
Sachsen-Anhalt
Country [87] 0 0
Germany
State/province [87] 0 0
Sachsen
Country [88] 0 0
Germany
State/province [88] 0 0
Schleswig-Holstein
Country [89] 0 0
Germany
State/province [89] 0 0
Berlin
Country [90] 0 0
Germany
State/province [90] 0 0
Hamburg
Country [91] 0 0
Italy
State/province [91] 0 0
Abruzzo
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Italy
State/province [92] 0 0
Lazio
Country [93] 0 0
Italy
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Lombardia
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Italy
State/province [94] 0 0
Marche
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Italy
State/province [95] 0 0
Milano
Country [96] 0 0
Italy
State/province [96] 0 0
Pavia
Country [97] 0 0
Italy
State/province [97] 0 0
Piemonte
Country [98] 0 0
Italy
State/province [98] 0 0
Salerno
Country [99] 0 0
Italy
State/province [99] 0 0
Sardegna
Country [100] 0 0
Italy
State/province [100] 0 0
Sicilia
Country [101] 0 0
Italy
State/province [101] 0 0
Catania
Country [102] 0 0
Italy
State/province [102] 0 0
Ferrara
Country [103] 0 0
Italy
State/province [103] 0 0
Firenze
Country [104] 0 0
Italy
State/province [104] 0 0
Foggia
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Italy
State/province [105] 0 0
Genova
Country [106] 0 0
Italy
State/province [106] 0 0
Livorno
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Italy
State/province [107] 0 0
Messina
Country [108] 0 0
Italy
State/province [108] 0 0
Modena
Country [109] 0 0
Italy
State/province [109] 0 0
Napoli
Country [110] 0 0
Italy
State/province [110] 0 0
Palermo
Country [111] 0 0
Italy
State/province [111] 0 0
Pordenone
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Italy
State/province [112] 0 0
Roma
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Japan
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Aichi
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Japan
State/province [114] 0 0
Fukuoka
Country [115] 0 0
Japan
State/province [115] 0 0
Hyogo
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Japan
State/province [116] 0 0
Ibaraki
Country [117] 0 0
Japan
State/province [117] 0 0
Ishikawa
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Japan
State/province [118] 0 0
Kanagawa
Country [119] 0 0
Japan
State/province [119] 0 0
Miyagi
Country [120] 0 0
Japan
State/province [120] 0 0
Osaka
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Japan
State/province [121] 0 0
Shimane
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Japan
State/province [122] 0 0
Shizuoka
Country [123] 0 0
Japan
State/province [123] 0 0
Tochigi
Country [124] 0 0
Japan
State/province [124] 0 0
Tokyo
Country [125] 0 0
Japan
State/province [125] 0 0
Fukushima
Country [126] 0 0
Japan
State/province [126] 0 0
Toyama
Country [127] 0 0
Japan
State/province [127] 0 0
Yamagata
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Korea, Republic of
State/province [128] 0 0
Daegu Gwang'yeogsi
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Korea, Republic of
State/province [129] 0 0
Gang'weondo
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Korea, Republic of
State/province [130] 0 0
Gwangju Gwang'yeogsi
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Korea, Republic of
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Gyeonggido
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Korea, Republic of
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Incheon Gwang'yeogsi
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Korea, Republic of
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Jeonrabugdo
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Korea, Republic of
State/province [134] 0 0
Seoul Teugbyeolsi
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Mexico
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Distrito Federal
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Mexico
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Hidalgo
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Mexico
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Jalisco
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Mexico
State/province [138] 0 0
Nuevo León
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Mexico
State/province [139] 0 0
Tabasco
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Mexico
State/province [140] 0 0
Mexico
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Netherlands
State/province [141] 0 0
Gelderland
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Netherlands
State/province [142] 0 0
Limburg
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Netherlands
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Noord-Brabant
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Netherlands
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Noord-Holland
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Netherlands
State/province [145] 0 0
Overijssel
Country [146] 0 0
Netherlands
State/province [146] 0 0
Utrecht
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Netherlands
State/province [147] 0 0
Zuid-Holland
Country [148] 0 0
Netherlands
State/province [148] 0 0
Groningen
Country [149] 0 0
Norway
State/province [149] 0 0
Akershus
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Norway
State/province [150] 0 0
Rogaland
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Norway
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Oslo
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Norway
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Trondheim
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Spain
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Asturias
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Spain
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Baleares
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Spain
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Barcelona
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Spain
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Canarias
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Spain
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Ciudad Real
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Spain
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Cádiz
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Spain
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Madrid
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Spain
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Murcia
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Spain
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Navarra
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Spain
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Pontevedra
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Spain
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Vizcaya
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Spain
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Badajoz
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Spain
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Burgos
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Spain
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Granada
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Spain
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Lugo
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Spain
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Málaga
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Spain
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Valladolid
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Spain
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Zaragoza
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Sweden
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Jönköpings Län
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Sweden
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Skåne Län
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Sweden
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Stockholms Län
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Sweden
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Uppsala Län
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Sweden
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Västra Götalands Län
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United Kingdom
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Carmarthenshire
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United Kingdom
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Essex
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United Kingdom
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Hampshire
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United Kingdom
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Hertfordshire
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United Kingdom
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Kensington And Chelsea
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United Kingdom
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Kingston Upon Hull, City Of
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United Kingdom
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Lancashire
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United Kingdom
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London, City Of
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United Kingdom
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North Lanarkshire
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United Kingdom
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North Yorkshire
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United Kingdom
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Northern Ireland
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United Kingdom
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Nottinghamshire
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United Kingdom
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South Tyneside
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United Kingdom
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York
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United Kingdom
State/province [190] 0 0
Birmingham
Country [191] 0 0
United Kingdom
State/province [191] 0 0
Liverpool
Country [192] 0 0
United Kingdom
State/province [192] 0 0
Manchester
Country [193] 0 0
United Kingdom
State/province [193] 0 0
Newport
Country [194] 0 0
United Kingdom
State/province [194] 0 0
Warwickshire

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
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Parexel
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02760329
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02760329