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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)
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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.
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Secondary ID [1]
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D2287R00103
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Universal Trial Number (UTN)
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Trial acronym
NOVELTY
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Asthma
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COPD
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Chronic Obstructive Pulmonary Disease
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Condition category
Condition code
Respiratory
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Asthma
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Respiratory
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Chronic obstructive pulmonary disease
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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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.
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Intervention code [1]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Spirometry - change in Forced Expiratory Volume in 1 second (FEV1) (Litres [L])
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Assessment method [1]
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Lung function test
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Timepoint [1]
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Change from baseline FEV1 at Year 1, 2 and 3
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Primary outcome [2]
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Spirometry - change in Forced Vital Capacity (FVC) (L)
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Assessment method [2]
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Lung function test
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Timepoint [2]
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Change from baseline FVC at Year 1, 2 and 3
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Primary outcome [3]
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Spirometry - change in Peak Expiratory Flow (PEF) (Litre/second [L/s])
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Assessment method [3]
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Lung function test
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Timepoint [3]
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Change from baseline PEF at Year 1, 2 and 3
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Primary outcome [4]
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Spirometry - change in Forced Expiratory Flow at 25-75% of the forced vital capacity (FEF25-75%) (L/s)
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Assessment method [4]
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Lung function test
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Timepoint [4]
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Change from baseline FEF25-75% at Year 1, 2 and 3
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Primary outcome [5]
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Spirometry - change in Inspiratory Capacity (IC) (L)
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Assessment method [5]
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Lung function test
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Timepoint [5]
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Change from baseline IC at Year 1, 2 and 3
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Primary outcome [6]
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Post-bronchodilator spirometry - FEV1 (L)
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Assessment method [6]
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Bronchodilator reversibility test
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Timepoint [6]
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Baseline
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Primary outcome [7]
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Post-bronchodilator spirometry - FVC (L)
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Assessment method [7]
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Bronchodilator reversibility test
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Timepoint [7]
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Baseline
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Primary outcome [8]
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Post-bronchodilator spirometry - PEF (L/s)
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Assessment method [8]
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Bronchodilator reversibility test
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Timepoint [8]
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Baseline
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Primary outcome [9]
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Post-bronchodilator spirometry - FEF25-75% (L/s)
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Assessment method [9]
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Bronchodilator reversibility test
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Timepoint [9]
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Baseline
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Primary outcome [10]
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Post-bronchodilator spirometry - IC (L)
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Assessment method [10]
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Bronchodilator reversibility test
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Timepoint [10]
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Baseline
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Primary outcome [11]
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Fractional exhaled nitric oxide (FeNO) (parts per billion [ppb])
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Assessment method [11]
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Test to measure fractional exhaled nitric oxide (ppb) levels in exhaled breath
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Timepoint [11]
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Baseline
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Primary outcome [12]
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Change in symptoms/symptom control assessed by the Chronic Airways Assessment Test (CAAT)
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Assessment method [12]
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Patient reported outcome questionnaire
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Timepoint [12]
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Change from baseline CAAT scores at Year 1, 2, and 3
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Primary outcome [13]
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Symptoms/symptom control assessed by the modified Medical Research Council (mMRC) scale
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Assessment method [13]
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Patient reported outcome questionnaire
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Timepoint [13]
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Baseline
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Primary outcome [14]
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Change in symptoms/symptom control assessed by the Respiratory Symptoms Questionnaire (RSQ)
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Assessment method [14]
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Patient reported outcome questionnaire
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Timepoint [14]
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Change from baseline RSQ scores at Year 1, 2 and 3
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Primary outcome [15]
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Change in symptoms/symptom control assessed by the Asthma Control Test (ACT)
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Assessment method [15]
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Patient reported outcome questionnaire
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Timepoint [15]
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Change from baseline ACT scores at Year 1, 2 and 3
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Primary outcome [16]
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COPD Foundation Primary Care Tool for Undiagnosed Respiratory Disease and Exacerbation Risk (CAPTURE) - to identify undiagnosed patients with clinically significant COPD
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Assessment method [16]
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Patient reported outcome questionnaire
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Timepoint [16]
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Baseline
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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
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Minimum age
12
Years
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Maximum age
130
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
25/07/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
31/05/2023
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Sample size
Target
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Accrual to date
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Final
12257
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Research Site - Blacktown
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Research Site - Crawley
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Recruitment hospital [22]
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Research Site - Spearwood
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Recruitment postcode(s) [1]
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2148 - Blacktown
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Recruitment postcode(s) [2]
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2050 - Camperdown
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Recruitment postcode(s) [3]
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2450 - Coffs Harbour
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Recruitment postcode(s) [4]
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2139 - Concord
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Recruitment postcode(s) [5]
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2259 - Kanwal
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Recruitment postcode(s) [6]
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2747 - Kingswood
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Recruitment postcode(s) [7]
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2170 - Liverpool
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Recruitment postcode(s) [8]
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2228 - Miranda
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Recruitment postcode(s) [9]
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2305 - New Lambton
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Recruitment postcode(s) [10]
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2031 - Randwick
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Recruitment postcode(s) [11]
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2109 - Sedney
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Recruitment postcode(s) [12]
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2260 - Wamberal
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Recruitment postcode(s) [13]
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4102 - Brisbane
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Recruitment postcode(s) [14]
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4020 - Redcliffe
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Recruitment postcode(s) [15]
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4101 - South Brisbane
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Recruitment postcode(s) [16]
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5042 - Bedford Park
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Recruitment postcode(s) [17]
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5159 - Happy Valley
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Recruitment postcode(s) [18]
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5011 - Woodville South
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Recruitment postcode(s) [19]
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3199 - Frankston
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Recruitment postcode(s) [20]
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3050 - Parkville
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Recruitment postcode(s) [21]
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6009 - Crawley
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Recruitment postcode(s) [22]
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6163 - Spearwood
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Recruitment outside Australia
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California
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Colorado
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Nebraska
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Milano
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Italy
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Messina
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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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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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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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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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Gang'weondo
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Gwangju Gwang'yeogsi
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Gyeonggido
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Incheon Gwang'yeogsi
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Jeonrabugdo
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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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Mexico
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Mexico
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Groningen
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Oslo
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Trondheim
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York
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Warwickshire
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AstraZeneca
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Parexel
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Ethics approval
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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.
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Trial website
https://clinicaltrials.gov/study/NCT02760329
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Trial related presentations / publications
Hughes R, Rapsomaniki E, Janson C, Keen C, Make BJ, Burgel PR, Tomaszewski EL, Mullerova H, Reddel HK; NOVELTY study investigators. Frequent productive cough: Symptom burden and future exacerbation risk among patients with asthma and/or COPD in the NOVELTY study. Respir Med. 2022 Aug-Sep;200:106921. doi: 10.1016/j.rmed.2022.106921. Epub 2022 Jun 20. Reddel HK, Vestbo J, Agusti A, Anderson GP, Bansal AT, Beasley R, Bel EH, Janson C, Make B, Pavord ID, Price D, Rapsomaniki E, Karlsson N, Finch DK, Nuevo J, de Giorgio-Miller A, Alacqua M, Hughes R, Mullerova H, Gerhardsson de Verdier M; NOVELTY study investigators. Heterogeneity within and between physician-diagnosed asthma and/or COPD: NOVELTY cohort. Eur Respir J. 2021 Sep 23;58(3):2003927. doi: 10.1183/13993003.03927-2020. Print 2021 Sep. Karlsson N, Atkinson MJ, Mullerova H, Alacqua M, Keen C, Hughes R, Janson C, Make B, Price D, Reddel HK; NOVELTY study investigators. Validation of a diagnosis-agnostic symptom questionnaire for asthma and/or COPD. ERJ Open Res. 2021 Feb 1;7(1):00828-2020. doi: 10.1183/23120541.00828-2020. eCollection 2021 Jan. Reddel HK, Gerhardsson de Verdier M, Agusti A, Anderson G, Beasley R, Bel EH, Janson C, Make B, Martin RJ, Pavord I, Price D, Keen C, Gardev A, Rennard S, Svereus A, Bansal AT, Brannman L, Karlsson N, Nuevo J, Nyberg F, Young SS, Vestbo J. Prospective observational study in patients with obstructive lung disease: NOVELTY design. ERJ Open Res. 2019 Feb 1;5(1):00036-2018. doi: 10.1183/23120541.00036-2018. eCollection 2019 Feb.
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Public notes
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Contacts
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
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Results not provided in
https://clinicaltrials.gov/study/NCT02760329
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