Last updated on June 2018

Observational Study of Obstructive Lung Disease (NOVELTY)


Brief description of study

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 Study 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.

Clinical Study Identifier: NCT02760329

Contact Investigators or Research Sites near you

Start Over

AstraZeneca Clinical Study Information Center

Research Site
Birmingham, AL United States
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Peoria, AZ United States
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Tucson, AZ United States
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Loma Linda, CA United States
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Long Beach, CA United States
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Oakland, CA United States
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Sacramento, CA United States
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Walnut Creek, CA United States
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Aurora, CO United States
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Colorado Springs, CO United States
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Clearwater, FL United States
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Coral Gables, FL United States
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Gainesville, FL United States
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Miami, FL United States
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Plantation, FL United States
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Atlanta, GA United States
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Decatur, GA United States
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Chicago, IL United States
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Springfield, IL United States
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Hutchinson, KS United States
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Hazard, KY United States
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Shreveport, LA United States
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Fall River, MA United States
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Ann Arbor, MI United States
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Buckley, MI United States
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Hamtramck, MI United States
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Saint Paul, MN United States
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Bellevue, NE United States
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Lincoln, NE United States
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Highland Park, NJ United States
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Albuquerque, NM United States
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
New York, NY United States
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Rockville Centre, NY United States
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Asheboro, NC United States
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Charlotte, NC United States
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Fargo, ND United States
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Cincinnati, OH United States
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Dayton, OH United States
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Wooster, OH United States
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Clackamas, OR United States
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
DuBois, PA United States
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Lansdale, PA United States
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
East Providence, RI United States
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Providence, RI United States
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Austin, TX United States
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Dallas, TX United States
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Houston, TX United States
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Live Oak, TX United States
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
San Antonio, TX United States
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Richmond, VA United States
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Charleston, WA United States
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Buenos Aires, Argentina
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Ciudad de Cordoba, Argentina
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Monte Grande, Argentina
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
San Miguel de Tucuman, Argentina
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
San Salvador, Argentina
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Bedford Park, Australia
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Coffs Harbour, Australia
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Happy Valley, Australia
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Liverpool BC, Australia
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Macquarie Park, Australia
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Randwick, NSW, Australia
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
South Brisbane, Australia
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Wentworthville, Australia
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
West Gosford, Australia
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Downsview, Ontario, ON Canada
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
St Catharines, ON Canada
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Saint-Jerome, QC Canada
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
St-Charles-Borromee, QC Canada
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Villavicencio, Colombia
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Aix en Provence, France
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Briis-sous-Forges, France
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Clermont Ferrand Cedex 1, France
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Clermont Ferrand, France
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Fleury sur Orne, France
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Orleans cedex 2, France
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Villefranche-sur-Saone, France
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Munchen-Gauting, Germany
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Acquaviva delle Fonti, Italy
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Sesto San Giovanni, Italy
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Anyang-si, Korea, Republic of
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Chuncheon-si, Korea, Republic of
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Gwangju, Korea, Republic of
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Gyeonggi-do, Korea, Republic of
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Incheon, Korea, Republic of
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Jeonju-si, Korea, Republic of
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Nam-gu, Korea, Republic of
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Seoul, Korea, Republic of
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Suwon-si, Korea, Republic of
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Wonmi-gu, Bucheon-si, Korea, Republic of
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Pachuca De Soto, Mexico
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Maastricht, Netherlands
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Nieuwegein, Netherlands
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Alcala de Henares, Spain
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Alcazar de San Juan, Spain
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Baracaldo, Bizcaia, Spain
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Palma de Mallorca, Spain
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Pozuelo de Alarcon, Spain
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Sta. Cruz de Tenerife, Spain
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Talavera de la Reina, Spain
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Belfast, United Kingdom
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Chelmsford, United Kingdom
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Doncaster, United Kingdom
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Edinburgh, United Kingdom
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Hampshire, United Kingdom
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Leicester, United Kingdom
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Liverpool, United Kingdom
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Macclesfield, United Kingdom
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Manchester, United Kingdom
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Middlesbrough, United Kingdom
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Newcastle upon Tyne, United Kingdom
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Newport, United Kingdom
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Norwich, United Kingdom
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Nottingham, United Kingdom
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Pickering, United Kingdom
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Sheffield, United Kingdom
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
South Shields, United Kingdom
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Southampton, United Kingdom
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Swansea, United Kingdom
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Watford, United Kingdom
  Connect »

AstraZeneca Clinical Study Information Center

Research Site
Bronx, NY United States
  Connect »