Observational Study of Obstructive Lung Disease (NOVELTY)

Asthma Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02760329
• Other study ID #: D2287R00103
• Status: Completed
• Start date: July 25, 2016
• Est. completion date: May 31, 2023

Study information

• Verified date: June 2023
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12257
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 130 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Chronic Obstructive Pulmonary Disease
• COPD
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Procedure:
• Blood draw
Biomarkers analyses
• Urine
Biomarker analyses
• Lung function measurements
FEV1, FVC, PEF, FEF25-75%, IC, calculated FEV1/FVC ratio and calculated FEV1 % predicted
• Fractional Exhaled Nitric Oxide (FENO)
Measures level of exhaled nitric oxide.

Locations

Country	Name	City	State
Argentina	Research Site	Buenos Aires
Argentina	Research Site	Buenos Aires
Argentina	Research Site	Buenos Aires
Argentina	Research Site	Buenos Aires
Argentina	Research Site	Buenos Aires	Ciudad Autónoma De Buenos Aires
Argentina	Research Site	Buenos Aires	Ciudad Autónoma De Buenos Aires
Argentina	Research Site	Concepcion del Uruguay	Entre Ríos
Argentina	Research Site	Córdoba
Argentina	Research Site	Mendoza
Argentina	Research Site	Monte Grande	Buenos Aires
Argentina	Research Site	Pilar	Buenos Aires
Argentina	Research Site	San Miguel de Tucumán	Tucumán
Argentina	Research Site	San Salvador	Entre Ríos
Argentina	Research Site	Tandil	Buenos Aires
Australia	Research Site	Bedford Park	South Australia
Australia	Research Site	Blacktown	New South Wales
Australia	Research Site	Brisbane	Queensland
Australia	Research Site	Camperdown	New South Wales
Australia	Research Site	Coffs Harbour	New South Wales
Australia	Research Site	Concord	New South Wales
Australia	Research Site	Crawley	Western Australia
Australia	Research Site	Frankston	Victoria
Australia	Research Site	Happy Valley	South Australia
Australia	Research Site	Kanwal	New South Wales
Australia	Research Site	Kingswood	New South Wales
Australia	Research Site	Liverpool	New South Wales
Australia	Research Site	Miranda	New South Wales
Australia	Research Site	New Lambton	New South Wales
Australia	Research Site	Parkville	Victoria
Australia	Research Site	Randwick	New South Wales
Australia	Research Site	Redcliffe	Queensland
Australia	Research Site	Sedney	New South Wales
Australia	Research Site	South Brisbane	Queensland
Australia	Research Site	Spearwood	Western Australia
Australia	Research Site	Wamberal	New South Wales
Australia	Research Site	Woodville South	South Australia
Brazil	Research Site	Blumenau	Santa Catarina
Brazil	Research Site	Goiânia	Goiás
Brazil	Research Site	Rio de Janeiro
Brazil	Research Site	São Paulo
Brazil	Research Site	Uberlândia	Minas Gerais
Canada	Research Site	Burlington	Ontario
Canada	Research Site	Downsview	Ontario
Canada	Research Site	Edmonton	Alberta
Canada	Research Site	Edmonton	Alberta
Canada	Research Site	Fort Erie	Ontario
Canada	Research Site	Hamilton	Ontario
Canada	Research Site	London	Ontario
Canada	Research Site	Mississauga	Ontario
Canada	Research Site	New Brunswick
Canada	Research Site	Oshawa	Ontario
Canada	Research Site	Quebec
Canada	Research Site	St-Charles-Borromée	Quebec
Canada	Research Site	Vancouver	British Columbia
Canada	Research Site	Windsor	Ontario
Canada	Research Site	Windsor	Ontario
China	Research Site	Baotou	Inner Mongolia
China	Research Site	Beijing	Beijing
China	Research Site	Beijing	Beijing
China	Research Site	Beijing	Beijing
China	Research Site	Changchun	Jilin
China	Research Site	Changsha	Henan
China	Research Site	Dongguan	Guangdong
China	Research Site	Dongguan	Guangdong
China	Research Site	Guangdong	Guangzhou
China	Research Site	Hangzhou	Zhejiang
China	Research Site	Hohhot	Inner Mongolia
China	Research Site	Jinan	Shandong
China	Research Site	Jinhua	Zhejiang
China	Research Site	Nanchang	Jiangxi
China	Research Site	Nanjing	Jiangsu
China	Research Site	Shanghai	Shanghai
China	Research Site	Shantou	Guangdong
China	Research Site	Shenzhen	Guangdong
China	Research Site	Shenzhen	Guangdong
China	Research Site	Shenzhen	Guangdong
China	Research Site	Shiyan	Hubei
China	Research Site	Sichuan	Chengdu
China	Research Site	Suzhou	Jiangsu
China	Research Site	Weifang	Shandong
China	Research Site	Xi'An	Shaanxi
China	Research Site	Yangzhou	Jiangsu
China	Research Site	Yanji	Jilin
China	Research Site	Zhengzhou	Henan
Colombia	Research Site	Antioquia
Colombia	Research Site	Bogota	Distrito Capital De Bogotá
Colombia	Research Site	Bogotá	Distrito Capital De Bogotá
Colombia	Research Site	Bucaramanga	Distrito Capital De Bogotá
Colombia	Research Site	Manizales	Caldas
Colombia	Research Site	Villavicencio	Meta
Colombia	Research Site	Zipaquira	Cundinamarca
Denmark	Research Site	Aarhus N	Central Jutland
Denmark	Research Site	Viby J	Central Jutland
France	Research Site	Aix en Provence	Provence-Alpes-Côte-d'Azur
France	Research Site	Bersee	Nord
France	Research Site	Besancon Cedex	Franche-Comté
France	Research Site	Biarritz	Pyrénées-Atlantiques
France	Research Site	Brest	Bretagne
France	Research Site	Brest cedex	Bretagne
France	Research Site	Caen	Calvados
France	Research Site	Clermont Ferrand Cedex 1	Auvergne
France	Research Site	Créteil	Val-de-Marne
France	Research Site	Dijon	Côte-d'Or
France	Research Site	Le Mans cedex	Sarthe
France	Research Site	Lille Cedex	Nord
France	Research Site	Limoges	Haute-Vienne
France	Research Site	Lyon	Rhône-Alpes
France	Research Site	Montpellier	Hérault
France	Research Site	Montvilliers	Seine-Maritime
France	Research Site	Mulhouse	Haut-Rhin
France	Research Site	Nancy	Meurthe-et-Moselle
France	Research Site	Orléans	Loiret
France	Research Site	Paris
France	Research Site	Paris	Île-de-France
France	Research Site	Pau Cedex	Aquitaine
France	Research Site	Pessac Cedex	Gironde
France	Research Site	Rouen Cedex	Seine-Maritime
France	Research Site	Strasbourg Cedex	Bas-Rhin
France	Research Site	Tarbes	Hautes-Pyrénées
France	Research Site	Villefranche-sur-Saône	Rhône
Germany	Research Site	Augsburg	Bayern
Germany	Research Site	Berlin
Germany	Research Site	Berlin
Germany	Research Site	Berlin
Germany	Research Site	Bruchsal	Baden-Württemberg
Germany	Research Site	Dillingen	Saarland
Germany	Research Site	Dresden	Sachsen
Germany	Research Site	Halberstadt	Sachsen-Anhalt
Germany	Research Site	Hamburg
Germany	Research Site	Hamburg
Germany	Research Site	Hamburg
Germany	Research Site	Heidelberg	Baden-Württemberg
Germany	Research Site	Ibbenbueren	Nordrhein-Westfalen
Germany	Research Site	Leipzig	Sachsen
Germany	Research Site	Luebeck	Schleswig-Holstein
Germany	Research Site	Marburg	Hessen
Germany	Research Site	Munich	Bayern
Germany	Research Site	Peine	Niedersachsen
Germany	Research Site	Ratingen	Nordrhein-Westfalen
Germany	Research Site	Reinfeld	Schleswig-Holstein
Germany	Research Site	Schleswig	Schleswig-Holstein
Italy	Research Site	Catania
Italy	Research Site	Chieti	Abruzzo
Italy	Research Site	Ferrara
Italy	Research Site	Firenze
Italy	Research Site	Foggia
Italy	Research Site	Genova
Italy	Research Site	Gravina Di Catania	Sicilia
Italy	Research Site	Livorno
Italy	Research Site	Mantova	Lombardia
Italy	Research Site	Messina
Italy	Research Site	Modena
Italy	Research Site	Montescano	Pavia
Italy	Research Site	Monza	Milano
Italy	Research Site	Napoli
Italy	Research Site	Orbassano	Piemonte
Italy	Research Site	Palermo
Italy	Research Site	Pordenone
Italy	Research Site	Roma
Italy	Research Site	Roma
Italy	Research Site	Roma
Italy	Research Site	Roma	Lazio
Italy	Research Site	Sassari	Sardegna
Italy	Research Site	Torre Del Greco (Napoli)	Salerno
Italy	Research Site	Torrette Di Ancona	Marche
Japan	Research Site	Chuo-ku	Tokyo
Japan	Research Site	Fukuoka
Japan	Research Site	Fukuoka-shi	Fukuoka
Japan	Research Site	Fukushima
Japan	Research Site	Higashiibaraki-gun	Ibaraki
Japan	Research Site	Ishinomaki	Miyagi
Japan	Research Site	Itami	Hyogo
Japan	Research Site	Kanazawa	Ishikawa
Japan	Research Site	Kanazawa-shi	Ishikawa
Japan	Research Site	Kishiwada	Osaka
Japan	Research Site	Kitakyushu	Fukuoka
Japan	Research Site	Kiyose	Tokyo
Japan	Research Site	Kobe	Hyogo
Japan	Research Site	Kurume	Fukuoka
Japan	Research Site	Matsue	Shimane
Japan	Research Site	Nagoya	Aichi
Japan	Research Site	Nakano-ku	Tokyo
Japan	Research Site	Omuta	Fukuoka
Japan	Research Site	Shimotsuga-gun	Tochigi
Japan	Research Site	Shizuoka
Japan	Research Site	Shizuoka, Shizuoka	Shizuoka
Japan	Research Site	Toyama
Japan	Research Site	Yamagata
Japan	Research Site	Yokohama	Kanagawa
Korea, Republic of	Research Site	Anyang-Si	Gyeonggido
Korea, Republic of	Research Site	Chuncheon-Si	Gang'weondo
Korea, Republic of	Research Site	Daegu	Daegu Gwang'yeogsi
Korea, Republic of	Research Site	Gwangju	Gwangju Gwang'yeogsi
Korea, Republic of	Research Site	Gyeonggi-do	Gyeonggido
Korea, Republic of	Research Site	Incheon	Incheon Gwang'yeogsi
Korea, Republic of	Research Site	Jeonju-Si	Jeonrabugdo
Korea, Republic of	Research Site	Seongnam-Si	Gyeonggido
Korea, Republic of	Research Site	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Research Site	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Research Site	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Research Site	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Research Site	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Research Site	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Research Site	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Research Site	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Research Site	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Research Site	Suwon-si	Gyeonggido
Mexico	Research Site	Guadalajara	Jalisco
Mexico	Research Site	Guadalajara	Jalisco
Mexico	Research Site	Mexico
Mexico	Research Site	Mexico	Distrito Federal
Mexico	Research Site	Monterrey	Nuevo León
Mexico	Research Site	Pachuca	Hidalgo
Mexico	Research Site	Villahermosa	Tabasco
Netherlands	Research Site	Alkmaar	Noord-Holland
Netherlands	Research Site	Arnhem	Gelderland
Netherlands	Research Site	Breda	Noord-Brabant
Netherlands	Research Site	Enschede	Overijssel
Netherlands	Research Site	Groningen
Netherlands	Research Site	Horn	Limburg
Netherlands	Research Site	Nieuwegein	Utrecht
Netherlands	Research Site	Nijmegen	Gelderland
Netherlands	Research Site	Rotterdam	Zuid-Holland
Netherlands	Research Site	Veldhoven	Noord-Brabant
Netherlands	Research Site	Zutphen	Gelderland
Norway	Research Site	Jassheim	Akershus
Norway	Research Site	Lørenskog	Akershus
Norway	Research Site	Oslo
Norway	Research Site	Tananger	Rogaland
Norway	Research Site	Trollåsen	Akershus
Norway	Research Site	Trondheim
Spain	Research Site	Alcalá de Henares	Madrid
Spain	Research Site	Alcázar de San Juan	Ciudad Real
Spain	Research Site	Badajoz
Spain	Research Site	Badalona	Barcelona
Spain	Research Site	Baracaldo	Vizcaya
Spain	Research Site	Barcelona
Spain	Research Site	Barcelona
Spain	Research Site	Burgos
Spain	Research Site	Cartagena	Murcia
Spain	Research Site	Centelles	Barcelona
Spain	Research Site	Granada
Spain	Research Site	Lugo
Spain	Research Site	Madrid
Spain	Research Site	Madrid
Spain	Research Site	Madrid
Spain	Research Site	Málaga
Spain	Research Site	Málaga
Spain	Research Site	Móstoles	Madrid
Spain	Research Site	Murcia
Spain	Research Site	Murcia
Spain	Research Site	Oviedo	Asturias
Spain	Research Site	Palma de Mallorca	Baleares
Spain	Research Site	Palmones	Cádiz
Spain	Research Site	Pamplona	Navarra
Spain	Research Site	Pozuelo de Alarcon	Madrid
Spain	Research Site	Sta. Cruz de Tenerife	Canarias
Spain	Research Site	Torrelaguna	Madrid
Spain	Research Site	Valladolid
Spain	Research Site	Vigo	Pontevedra
Spain	Research Site	Vigo	Pontevedra
Spain	Research Site	Zaragoza
Sweden	Research Site	Göteborg	Västra Götalands Län
Sweden	Research Site	Lund	Skåne Län
Sweden	Research Site	Stockholm	Stockholms Län
Sweden	Research Site	Uppsala	Uppsala Län
Sweden	Research Site	Uppsala	Uppsala Län
Sweden	Research Site	Värnamo	Jönköpings Län
United Kingdom	Research Site	Belfast	Northern Ireland
United Kingdom	Research Site	Birmingham
United Kingdom	Research Site	Chelmsford	Essex
United Kingdom	Research Site	Hull	Kingston Upon Hull, City Of
United Kingdom	Research Site	Liverpool
United Kingdom	Research Site	London	London, City Of
United Kingdom	Research Site	Manchester
United Kingdom	Research Site	Manchester
United Kingdom	Research Site	Middlesborough	Kensington And Chelsea
United Kingdom	Research Site	Newport
United Kingdom	Research Site	Nottingham	Nottinghamshire
United Kingdom	Research Site	Pickering	York
United Kingdom	Research Site	Southampton	Hampshire
United Kingdom	Research Site	Swansea	Carmarthenshire
United Kingdom	Research Site	Thornton Cleveleys	Lancashire
United Kingdom	Research Site	Tyne And Wear	South Tyneside
United Kingdom	Research Site	Warwickshire
United Kingdom	Research Site	Watford	Hertfordshire
United Kingdom	Research Site	Wishaw	North Lanarkshire
United Kingdom	Research Site	York	North Yorkshire
United Kingdom	Research Site	York	North Yorkshire
United Kingdom	Research Site	York	North Yorkshire
United Kingdom	Research Site	York
United States	Research Site	Albuquerque	New Mexico
United States	Research Site	Altoona	Pennsylvania
United States	Research Site	Ann Arbor	Michigan
United States	Research Site	Aurora	Colorado
United States	Research Site	Austin	Texas
United States	Research Site	Bronx	New York
United States	Research Site	Bronx	New York
United States	Research Site	Bronx	New York
United States	Research Site	Buckley	Michigan
United States	Research Site	Charleston	West Virginia
United States	Research Site	Chicago	Illinois
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Clearwater	Florida
United States	Research Site	Colorado Springs	Colorado
United States	Research Site	Fall River	Massachusetts
United States	Research Site	Fargo	North Dakota
United States	Research Site	Gainesville	Florida
United States	Research Site	Hamtramck	Michigan
United States	Research Site	Highland Park	New Jersey
United States	Research Site	Houston	Texas
United States	Research Site	Hutchinson	Kansas
United States	Research Site	Kettering	Ohio
United States	Research Site	Lincoln	Nebraska
United States	Research Site	Live Oak	Texas
United States	Research Site	Loma Linda	California
United States	Research Site	Long Beach	California
United States	Research Site	Miami	Florida
United States	Research Site	Miami	Florida
United States	Research Site	New York	New York
United States	Research Site	New York	New York
United States	Research Site	Normal	Illinois
United States	Research Site	Plantation	Florida
United States	Research Site	Providence	Rhode Island
United States	Research Site	Richmond	Virginia
United States	Research Site	Rockville Centre	New York
United States	Research Site	Roseville	California
United States	Research Site	San Antonio	Texas
United States	Research Site	Shreveport	Louisiana
United States	Research Site	W. Berlin	New Jersey
United States	Research Site	Wooster	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Parexel

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  Canada,  China,  Colombia,  Denmark,  France,  Germany,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  Norway,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spirometry - change in Forced Expiratory Volume in 1 second (FEV1) (Litres [L])	Lung function test	Change from baseline FEV1 at Year 1, 2 and 3
Primary	Spirometry - change in Forced Vital Capacity (FVC) (L)	Lung function test	Change from baseline FVC at Year 1, 2 and 3
Primary	Spirometry - change in Peak Expiratory Flow (PEF) (Litre/second [L/s])	Lung function test	Change from baseline PEF at Year 1, 2 and 3
Primary	Spirometry - change in Forced Expiratory Flow at 25-75% of the forced vital capacity (FEF25-75%) (L/s)	Lung function test	Change from baseline FEF25-75% at Year 1, 2 and 3
Primary	Spirometry - change in Inspiratory Capacity (IC) (L)	Lung function test	Change from baseline IC at Year 1, 2 and 3
Primary	Post-bronchodilator spirometry - FEV1 (L)	Bronchodilator reversibility test	Baseline
Primary	Post-bronchodilator spirometry - FVC (L)	Bronchodilator reversibility test	Baseline
Primary	Post-bronchodilator spirometry - PEF (L/s)	Bronchodilator reversibility test	Baseline
Primary	Post-bronchodilator spirometry - FEF25-75% (L/s)	Bronchodilator reversibility test	Baseline
Primary	Post-bronchodilator spirometry - IC (L)	Bronchodilator reversibility test	Baseline
Primary	Fractional exhaled nitric oxide (FeNO) (parts per billion [ppb])	Test to measure fractional exhaled nitric oxide (ppb) levels in exhaled breath	Baseline
Primary	Change in symptoms/symptom control assessed by the Chronic Airways Assessment Test (CAAT)	Patient reported outcome questionnaire	Change from baseline CAAT scores at Year 1, 2, and 3
Primary	Symptoms/symptom control assessed by the modified Medical Research Council (mMRC) scale	Patient reported outcome questionnaire	Baseline
Primary	Change in symptoms/symptom control assessed by the Respiratory Symptoms Questionnaire (RSQ)	Patient reported outcome questionnaire	Change from baseline RSQ scores at Year 1, 2 and 3
Primary	Change in symptoms/symptom control assessed by the Asthma Control Test (ACT)	Patient reported outcome questionnaire	Change from baseline ACT scores at Year 1, 2 and 3
Primary	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	Baseline

External Links

•   NOVELTY_protocol_v1_with_amendment_history_REDACTED