Observational Study of Obstructive Lung Disease (NOVELTY)

Completed

Conditions studied: Asthma, COPD, Chronic Obstructive Pulmonary Disease

In brief

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.

Key facts

Study ID

NCT02760329

Run by

AstraZeneca

People needed

12255

Starts

2016-07-25

Expected to finish

2023-05-31

Last updated by the study team

2024-10-03

Who can join

Age: 12 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Research Site — Long Beach, California, United States
• Research Site — Roseville, California, United States
• Research Site — Aurora, Colorado, United States
• Research Site — Colorado Springs, Colorado, United States
• Research Site — Clearwater, Florida, United States
• Research Site — Gainesville, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — Plantation, Florida, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Normal, Illinois, United States
• Research Site — Hutchinson, Kansas, United States
• Research Site — Shreveport, Louisiana, United States
• Research Site — Fall River, Massachusetts, United States
• Research Site — Ann Arbor, Michigan, United States
• Research Site — Buckley, Michigan, United States
• Research Site — Hamtramck, Michigan, United States
• Research Site — Lincoln, Nebraska, United States
• Research Site — Highland Park, New Jersey, United States
• Research Site — West Berlin, New Jersey, United States
• Research Site — Albuquerque, New Mexico, United States
• Research Site — New York, New York, United States
• Research Site — New York, New York, United States
• Research Site — Rockville Centre, New York, United States
• Research Site — Loma Linda, California, United States

Full record on ClinicalTrials.gov

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