Clinical trial NCT02760329: Observational Study of Obstructive Lung Disease (NOVELTY)
Official title: A NOVEL Observational longiTudinal studY on Patients With Asthma and/or COPD to Describe Patient Characteristics, Treatment Patterns and the Burden of Illness Over Time and to Identify Phenotypes and Endotypes.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
COPD
Chronic Obstructive Pulmonary Disease
Keywords: asthma
COPD
chronic obstructive pulmonary disease
lung disease
chronic airways disease
obstructive lung disease
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Parexel
First posted: 2016-05-03
Enrollment: 12255
Sex: ALL
Minimum age (years): 12
Maximum age (years): 130
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with suspected or primary diagnosis of asthma and with suspected or primary diagnosis of COPD will be enrolled by a diverse set of physicians (e.g. primary care physicians, allergists, pulmonologists) from community and hospital outpatient settings.

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.

Detailed description: The NOVELTY study is a multi-country, multicentre, observational, prospective, longitudinal cohort study which will include patients with a physician diagnosis, or suspected diagnosis, of asthma and/or COPD. Patients will undergo clinical assessments and receive standard medical care as determined by the treating physician. All patients enrolled in the NOVELTY study will be followed up yearly by their treating physician for a total duration of three years. In addition, patients are expected to be followed up remotely once every quarter.

It is estimated that approximately 7,700 patients with suspected or primary diagnosis of asthma and 7,100 patients with suspected or primary diagnosis of COPD will be enrolled by a diverse set of physicians (e.g. primary care physicians, allergists, pulmonologists) from community and hospital outpatient settings within the countries targeted for NOVELTY.

Exposure(s):

The NOVELTY study is a longitudinal cohort study which does not involve or study a specific medicinal product; it will constitute a disease registry. Information about exposure to treatments as part of routine care will be collected (frequency, treatment, duration).

Sample Size Estimations:

The target minimum number of 100 patients per diagnostic label (asthma or COPD), physician-assessed severity level and country has been chosen to support many basic local reimbursement specific requirements with reasonable precision, and to provide large sample size for scientific questions applicable across severities and countries. Therefore, considering the targeted countries, it is estimated that approximately 7,700 patients with asthma and 7,100 patients with COPD will be enrolled.

Statistical Analysis:

After baseline data collection and each annual data collection, data will be summarized for the population overall and by pre specified subgroups, including by country, demographics, exposures, symptom history, treatment history, concurrent clinical features, treatment setting, socioeconomic setting and access to healthcare, where relevant.

Patients' changes regarding their treatment, disease or severity among and other variables that are observed between baseline and follow-up visits, will also be described.

To identify potential differences in disease diagnosis and severity classifications between physicians and guidelines, data collected on lung function results, symptom questionnaires, exacerbation occurrences and medication will allow the formal and consistent classification of the patients according to relevant international guidelines and other current and future phenotypic/diagnostic classifications.

Multivariable models will be used to assess the following: the occurrence of exacerbations and other conditions, including upper and lower Respiratory Tract Infections (RTIs) and their relationship with clinical outcomes, the relationship between Patient Reported Outcomes (PRO) and disease control with impact on daily activity and quality of life, and the relationship between healthcare resource use overall and related to respiratory diseases with disease severity, clinical outcomes, disease type, etc.

Multivariable analysis techniques will be used to identify phenotypes and endotypes, based on biomarkers and/or clinical parameters that are associated with differential outcomes for symptom burden, clinical evolution and healthcare utilisation.

Eligibility criteria: 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

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

Primary outcomes:
measure: Spirometry - change in Forced Expiratory Volume in 1 second (FEV1) (Litres [L])
timeFrame: Change from baseline FEV1 at Year 1, 2 and 3
measure: Spirometry - change in Forced Vital Capacity (FVC) (L)
timeFrame: Change from baseline FVC at Year 1, 2 and 3
measure: Spirometry - change in Peak Expiratory Flow (PEF) (Litre/second [L/s])
timeFrame: Change from baseline PEF at Year 1, 2 and 3
measure: Spirometry - change in Forced Expiratory Flow at 25-75% of the forced vital capacity (FEF25-75%) (L/s)
timeFrame: Change from baseline FEF25-75% at Year 1, 2 and 3
measure: Spirometry - change in Inspiratory Capacity (IC) (L)
timeFrame: Change from baseline IC at Year 1, 2 and 3
measure: Post-bronchodilator spirometry - FEV1 (L)
timeFrame: Baseline
measure: Post-bronchodilator spirometry - FVC (L)
timeFrame: Baseline
measure: Post-bronchodilator spirometry - PEF (L/s)
timeFrame: Baseline
measure: Post-bronchodilator spirometry - FEF25-75% (L/s)
timeFrame: Baseline
measure: Post-bronchodilator spirometry - IC (L)
timeFrame: Baseline
measure: Fractional exhaled nitric oxide (FeNO) (parts per billion [ppb])
timeFrame: Baseline
measure: Change in symptoms/symptom control assessed by the Chronic Airways Assessment Test (CAAT)
timeFrame: Change from baseline CAAT scores at Year 1, 2, and 3
measure: Symptoms/symptom control assessed by the modified Medical Research Council (mMRC) scale
timeFrame: Baseline
measure: Change in symptoms/symptom control assessed by the Respiratory Symptoms Questionnaire (RSQ)
timeFrame: Change from baseline RSQ scores at Year 1, 2 and 3
measure: Change in symptoms/symptom control assessed by the Asthma Control Test (ACT)
timeFrame: Change from baseline ACT scores at Year 1, 2 and 3
measure: COPD Foundation Primary Care Tool for Undiagnosed Respiratory Disease and Exacerbation Risk (CAPTURE) - to identify undiagnosed patients with clinically significant COPD
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
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state: Baden-Württemberg
city: Heidelberg
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state: Baden-Württemberg
city: Augsburg
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state: Bayern
city: Munich
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state: Bayern
city: Marburg
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state: Nordrhein-Westfalen
city: Ratingen
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state: Nordrhein-Westfalen
city: Dillingen
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state: Saarland
city: Halberstadt
country: Germany
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state: Sachsen-Anhalt
city: Dresden
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facility: Research Site
state: Sachsen
city: Leipzig
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state: Sachsen
city: Luebeck
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state: Schleswig-Holstein
city: Reinfeld
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country: Korea, Republic of
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country: Korea, Republic of
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country: Korea, Republic of
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city: Seoul
country: Korea, Republic of
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state: Seoul Teugbyeolsi
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country: Korea, Republic of
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city: Seoul
country: Korea, Republic of
facility: Research Site
state: Seoul Teugbyeolsi
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country: Korea, Republic of
facility: Research Site
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Research Site
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Research Site
state: Seoul Teugbyeolsi
city: Mexico
country: Mexico
facility: Research Site
state: Distrito Federal
city: Pachuca
country: Mexico
facility: Research Site
state: Hidalgo
city: Guadalajara
country: Mexico
facility: Research Site
state: Jalisco
city: Guadalajara
country: Mexico
facility: Research Site
state: Jalisco
city: Monterrey
country: Mexico
facility: Research Site
state: Nuevo León
city: Villahermosa
country: Mexico
facility: Research Site
state: Tabasco
city: Mexico
country: Mexico
facility: Research Site
city: Arnhem
country: Netherlands
facility: Research Site
state: Gelderland
city: Nijmegen
country: Netherlands
facility: Research Site
state: Gelderland
city: Zutphen
country: Netherlands
facility: Research Site
state: Gelderland
city: Horn
country: Netherlands
facility: Research Site
state: Limburg
city: Breda
country: Netherlands
facility: Research Site
state: Noord-Brabant
city: Veldhoven
country: Netherlands
facility: Research Site
state: Noord-Brabant
city: Alkmaar
country: Netherlands
facility: Research Site
state: Noord-Holland
city: Enschede
country: Netherlands
facility: Research Site
state: Overijssel
city: Nieuwegein
country: Netherlands
facility: Research Site
state: Utrecht
city: Rotterdam
country: Netherlands
facility: Research Site
state: Zuid-Holland
city: Groningen
country: Netherlands
facility: Research Site
city: Jassheim
country: Norway
facility: Research Site
state: Akershus
city: Lørenskog
country: Norway
facility: Research Site
state: Akershus
city: Trollåsen
country: Norway
facility: Research Site
state: Akershus
city: Tananger
country: Norway
facility: Research Site
state: Rogaland
city: Oslo
country: Norway
facility: Research Site
city: Trondheim
country: Norway
facility: Research Site
city: Oviedo
country: Spain
facility: Research Site
state: Asturias
city: Palma de Mallorca
country: Spain
facility: Research Site
state: Baleares
city: Badalona
country: Spain
facility: Research Site
state: Barcelona
city: Centelles
country: Spain
facility: Research Site
state: Barcelona
city: Sta. Cruz de Tenerife
country: Spain
facility: Research Site
state: Canarias
city: Alcázar de San Juan
country: Spain
facility: Research Site
state: Ciudad Real
city: Palmones
country: Spain
facility: Research Site
state: Cádiz
city: Alcalá de Henares
country: Spain
facility: Research Site
state: Madrid
city: Móstoles
country: Spain
facility: Research Site
state: Madrid
city: Pozuelo de Alarcon
country: Spain
facility: Research Site
state: Madrid
city: Torrelaguna
country: Spain
facility: Research Site
state: Madrid
city: Cartagena
country: Spain
facility: Research Site
state: Murcia
city: Pamplona
country: Spain
facility: Research Site
state: Navarra
city: Vigo
country: Spain
facility: Research Site
state: Pontevedra
city: Vigo
country: Spain
facility: Research Site
state: Pontevedra
city: Baracaldo
country: Spain
facility: Research Site
state: Vizcaya
city: Badajoz
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Burgos
country: Spain
facility: Research Site
city: Granada
country: Spain
facility: Research Site
city: Lugo
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Murcia
country: Spain
facility: Research Site
city: Murcia
country: Spain
facility: Research Site
city: Málaga
country: Spain
facility: Research Site
city: Málaga
country: Spain
facility: Research Site
city: Valladolid
country: Spain
facility: Research Site
city: Zaragoza
country: Spain
facility: Research Site
city: Värnamo
country: Sweden
facility: Research Site
state: Jönköpings Län
city: Lund
country: Sweden
facility: Research Site
state: Skåne Län
city: Stockholm
country: Sweden
facility: Research Site
state: Stockholms Län
city: Uppsala
country: Sweden
facility: Research Site
state: Uppsala Län
city: Uppsala
country: Sweden
facility: Research Site
state: Uppsala Län
city: Göteborg
country: Sweden
facility: Research Site
state: Västra Götalands Län
city: Swansea
country: United Kingdom
facility: Research Site
state: Carmarthenshire
city: Chelmsford
country: United Kingdom
facility: Research Site
state: Essex
city: Southampton
country: United Kingdom
facility: Research Site
state: Hampshire
city: Watford
country: United Kingdom
facility: Research Site
state: Hertfordshire
city: Middlesborough
country: United Kingdom
facility: Research Site
state: Kensington And Chelsea
city: Hull
country: United Kingdom
facility: Research Site
state: Kingston Upon Hull, City Of
city: Thornton Cleveleys
country: United Kingdom
facility: Research Site
state: Lancashire
city: London
country: United Kingdom
facility: Research Site
state: London, City Of
city: Wishaw
country: United Kingdom
facility: Research Site
state: North Lanarkshire
city: York
country: United Kingdom
facility: Research Site
state: North Yorkshire
city: York
country: United Kingdom
facility: Research Site
state: North Yorkshire
city: York
country: United Kingdom
facility: Research Site
state: North Yorkshire
city: Belfast
country: United Kingdom
facility: Research Site
state: Northern Ireland
city: Nottingham
country: United Kingdom
facility: Research Site
state: Nottinghamshire
city: Tyne And Wear
country: United Kingdom
facility: Research Site
state: South Tyneside
city: Pickering
country: United Kingdom
facility: Research Site
state: York
city: Birmingham
country: United Kingdom
facility: Research Site
city: Liverpool
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
city: Newport
country: United Kingdom
facility: Research Site
city: Warwickshire
country: United Kingdom
facility: Research Site
city: York
country: United Kingdom
facility: Research Site
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.