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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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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Pennsylvania
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West Virginia
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Argentina
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Ciudad Autónoma De Buenos Aires
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Argentina
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Mendoza
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Goiás
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Brazil
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Santa Catarina
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Brazil
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Rio de Janeiro
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Brazil
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São Paulo
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Alberta
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British Columbia
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Jilin
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Hérault
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Loiret
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Meurthe-et-Moselle
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Bayern
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Hessen
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Germany
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Nordrhein-Westfalen
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Germany
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Saarland
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Germany
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Sachsen-Anhalt
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Germany
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Sachsen
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Germany
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Schleswig-Holstein
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Germany
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Berlin
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Germany
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Hamburg
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Italy
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Abruzzo
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Italy
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Lazio
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Italy
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Lombardia
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Italy
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Marche
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Italy
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Milano
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Italy
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Pavia
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Italy
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Piemonte
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Italy
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Salerno
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Italy
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Sardegna
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Italy
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Sicilia
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Italy
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Catania
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Italy
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Ferrara
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Italy
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Firenze
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Italy
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Foggia
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Italy
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Genova
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Italy
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Livorno
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Italy
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Messina
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Italy
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Modena
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Italy
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Napoli
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Italy
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Palermo
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Italy
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Pordenone
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Italy
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Roma
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Japan
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Aichi
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Japan
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Fukuoka
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Japan
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Hyogo
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Japan
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Ibaraki
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Japan
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Ishikawa
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Japan
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Kanagawa
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Japan
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Miyagi
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Japan
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Osaka
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Japan
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Shimane
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Japan
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Shizuoka
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Japan
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Tochigi
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Japan
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Tokyo
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Japan
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Fukushima
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Japan
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Toyama
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Japan
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Yamagata
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Korea, Republic of
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Daegu Gwang'yeogsi
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Korea, Republic of
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Gang'weondo
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Korea, Republic of
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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
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Seoul Teugbyeolsi
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Mexico
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Distrito Federal
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Hidalgo
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Jalisco
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Mexico
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Tabasco
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Mexico
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Netherlands
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Gelderland
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Limburg
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Noord-Brabant
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Noord-Holland
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Overijssel
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Netherlands
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Utrecht
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Zuid-Holland
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Netherlands
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Groningen
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Norway
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Akershus
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Rogaland
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Oslo
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Barcelona
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Sweden
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Stockholms Län
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Sweden
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Sweden
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Essex
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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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Kingston Upon Hull, City Of
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Lancashire
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London, City Of
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North Lanarkshire
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North Yorkshire
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Northern Ireland
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Nottinghamshire
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South Tyneside
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United Kingdom
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York
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United Kingdom
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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
Name [1] 0 0
Parexel
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02760329