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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02760329
Ethics application status
Date submitted
5/04/2016
Date registered
3/05/2016
Date last updated
17/07/2019

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]) - Lung function test
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) - Lung function test
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]) - Lung function test
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) - Lung function test
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) - Lung function test
Timepoint [5] 0 0
Change from baseline IC at Year 1, 2 and 3
Primary outcome [6] 0 0
Post-bronchodilator spirometry - FEV1 (L) - Bronchodilator reversibility test
Timepoint [6] 0 0
Baseline
Primary outcome [7] 0 0
Post-bronchodilator spirometry - FVC (L) - Bronchodilator reversibility test
Timepoint [7] 0 0
Baseline
Primary outcome [8] 0 0
Post-bronchodilator spirometry - PEF (L/s) - Bronchodilator reversibility test
Timepoint [8] 0 0
Baseline
Primary outcome [9] 0 0
Post-bronchodilator spirometry - FEF25-75% (L/s) - Bronchodilator reversibility test
Timepoint [9] 0 0
Baseline
Primary outcome [10] 0 0
Post-bronchodilator spirometry - IC (L) - Bronchodilator reversibility test
Timepoint [10] 0 0
Baseline
Primary outcome [11] 0 0
Fractional exhaled nitric oxide (FeNO) (parts per billion [ppb]) - Test to measure fractional exhaled nitric oxide (ppb) levels in exhaled breath
Timepoint [11] 0 0
Baseline
Primary outcome [12] 0 0
Change in symptoms/symptom control assessed by the Chronic Airways Assessment Test (CAAT) - Patient reported outcome questionnaire
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 - Patient reported outcome questionnaire
Timepoint [13] 0 0
Baseline
Primary outcome [14] 0 0
Change in symptoms/symptom control assessed by the Respiratory Symptoms Questionnaire (RSQ) - Patient reported outcome questionnaire
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) - Patient reported outcome questionnaire
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 - Patient reported outcome questionnaire
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
No limit
Gender
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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Bedford Park
Recruitment hospital [2] 0 0
Research Site - Blacktown
Recruitment hospital [3] 0 0
Research Site - Cairns
Recruitment hospital [4] 0 0
Research Site - Coffs Harbour
Recruitment hospital [5] 0 0
Research Site - Concord
Recruitment hospital [6] 0 0
Research Site - Frankston
Recruitment hospital [7] 0 0
Research Site - Glebe
Recruitment hospital [8] 0 0
Research Site - Happy Valley
Recruitment hospital [9] 0 0
Research Site - Kanwal
Recruitment hospital [10] 0 0
Research Site - Kingswood
Recruitment hospital [11] 0 0
Research Site - Kippa Ring
Recruitment hospital [12] 0 0
Research Site - Kippa-Ring
Recruitment hospital [13] 0 0
Research Site - Kogarah
Recruitment hospital [14] 0 0
Research Site - Liverpool BC
Recruitment hospital [15] 0 0
Research Site - Macquarie Park
Recruitment hospital [16] 0 0
Research Site - Nedlands
Recruitment hospital [17] 0 0
Research Site - New Lambton
Recruitment hospital [18] 0 0
Research Site - Parkville
Recruitment hospital [19] 0 0
Research Site - Randwick, NSW
Recruitment hospital [20] 0 0
Research Site - South Brisbane
Recruitment hospital [21] 0 0
Research Site - Subiaco
Recruitment hospital [22] 0 0
Research Site - Wamberal
Recruitment hospital [23] 0 0
Research Site - West Gosford
Recruitment hospital [24] 0 0
Research Site - Woodville
Recruitment postcode(s) [1] 0 0
- Bedford Park
Recruitment postcode(s) [2] 0 0
- Blacktown
Recruitment postcode(s) [3] 0 0
- Cairns
Recruitment postcode(s) [4] 0 0
- Coffs Harbour
Recruitment postcode(s) [5] 0 0
- Concord
Recruitment postcode(s) [6] 0 0
- Frankston
Recruitment postcode(s) [7] 0 0
- Glebe
Recruitment postcode(s) [8] 0 0
- Happy Valley
Recruitment postcode(s) [9] 0 0
- Kanwal
Recruitment postcode(s) [10] 0 0
- Kingswood
Recruitment postcode(s) [11] 0 0
- Kippa Ring
Recruitment postcode(s) [12] 0 0
- Kippa-Ring
Recruitment postcode(s) [13] 0 0
- Kogarah
Recruitment postcode(s) [14] 0 0
- Liverpool BC
Recruitment postcode(s) [15] 0 0
- Macquarie Park
Recruitment postcode(s) [16] 0 0
- Nedlands
Recruitment postcode(s) [17] 0 0
- New Lambton
Recruitment postcode(s) [18] 0 0
- Parkville
Recruitment postcode(s) [19] 0 0
- Randwick, NSW
Recruitment postcode(s) [20] 0 0
- South Brisbane
Recruitment postcode(s) [21] 0 0
- Subiaco
Recruitment postcode(s) [22] 0 0
- Wamberal
Recruitment postcode(s) [23] 0 0
- West Gosford
Recruitment postcode(s) [24] 0 0
- Woodville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
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Florida
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United States of America
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Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Kansas
Country [6] 0 0
United States of America
State/province [6] 0 0
Louisiana
Country [7] 0 0
United States of America
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Massachusetts
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United States of America
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Michigan
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Nebraska
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United States of America
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New Jersey
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United States of America
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New Mexico
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United States of America
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New York
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United States of America
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North Dakota
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United States of America
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Ohio
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Oregon
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United States of America
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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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United States of America
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Washington
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Argentina
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Buenos Aires
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Argentina
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Caba
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Argentina
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Cordoba
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Argentina
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Mendoza
Country [25] 0 0
Argentina
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Monte Grande
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Argentina
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Pilar
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Argentina
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San Miguel de Tucuman
Country [28] 0 0
Argentina
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San Salvador
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Argentina
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Tandil
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Brazil
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Blumenau
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Goiania
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Rio de Janeiro
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Sao Paulo
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Uberlandia
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Alberta
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New Brunswick
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Ontario
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China
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Shiyan
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Suzhou Shi
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Wei Fang
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Yangzhou
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China
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Yanji
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China
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Zhengzhou
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Colombia
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Antioquia
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Colombia
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Bogota
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Colombia
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Bucaramanga
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Colombia
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Manizales
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Colombia
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Villavicencio
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Colombia
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Zipaquira
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Denmark
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Aalborg
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Denmark
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Aarhus
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Vejle
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Brest
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Dijon
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Fleury sur Orne
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Le Mans
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Lille Cedex
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France
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Limoges
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France
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Lyon
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France
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Montivilliers
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France
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Montpellier
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France
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Nancy
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France
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Orleans cedex 2
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France
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Paris
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France
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Pau
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France
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Perpignan
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France
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Rouen
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France
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Strasbourg
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France
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Tarbes
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France
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Vesoul
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France
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Villefranche-sur-Saone
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Germany
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Augsburg
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Germany
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Berlin
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Germany
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Bruchsal
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Germany
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Dillingen
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Germany
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Germany
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Halberstadt
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Hamburg
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Germany
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Heidelberg
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Homburg
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Germany
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Leipzig
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Luebeck
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Germany
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Marburg
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Germany
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Munich
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Germany
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Peine
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Germany
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Ratingen
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Reinfeld
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Germany
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Germany
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Italy
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Battipaglia
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Italy
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Biancavilla
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Italy
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Catania
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Italy
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Chieti
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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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Mantova
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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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Montescano
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Italy
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Monza
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Italy
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Napoli
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Italy
State/province [134] 0 0
Orbassano
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Italy
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Palermo
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Italy
State/province [136] 0 0
Pordenone
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Italy
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Roma
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Italy
State/province [138] 0 0
Sassari
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Japan
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Fukuoka-shi
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Japan
State/province [140] 0 0
Fukuoka
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Japan
State/province [141] 0 0
Fukushima
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Japan
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Higashiibaraki
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Japan
State/province [143] 0 0
Ishinomaki
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Japan
State/province [144] 0 0
Itami
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Japan
State/province [145] 0 0
Kanazawa
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Japan
State/province [146] 0 0
Kishiwada
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Japan
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Kitakyu
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Japan
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Kiyose
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Japan
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Kobe
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Japan
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Kurume-Shi
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Japan
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Matsue
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Japan
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Mibu-Machi
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Japan
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Nagoya
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Japan
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Nakano-ku
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Japan
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Omuta-shi
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Japan
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Shizuoka-shi
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Japan
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Shizuoka
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Japan
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Tokyo
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Japan
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Toyama
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Japan
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Yamagata
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Yokohama
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Korea, Republic of
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Korea, Republic of
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Gwangju
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Korea, Republic of
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Gyeonggi-do
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Incheon
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Jeonju-si
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Korea, Republic of
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Nam-gu
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Korea, Republic of
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Seoul
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Korea, Republic of
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Suwon-si
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Korea, Republic of
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Wonmi-gu, Bucheon-si
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Mexico
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Guadalajara
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Mexico
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Mexico
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Mexico
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Monterrey
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Pachuca De Soto
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Mexico
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Puebla
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Mexico
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Villahermosa
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Netherlands
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Alkmaar
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Arnhem
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Breda
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Enschede
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Groningen
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Maastricht
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Nieuwegein
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Nijmegen
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Netherlands
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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
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/show/NCT02760329
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Maria Gerhardsson de Verdier
Address 0 0
AstraZeneca
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
Other publications