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Observational Study of Obstructive Lung Disease (NOVELTY)
Observational Study of Obstructive Lung Disease (NOVELTY)

NCT02760329

CompletedN/A

Sponsor: AstraZeneca

Conditions: Asthma, COPD, Chronic Obstructive Pulmonary Disease

Interventions: Blood draw, Urine, Lung function measurements, Fractional Exhaled Nitric Oxide (FENO)

Countries: United States, Argentina, Australia, Brazil, Canada, China, Colombia, Denmark

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.

Eligibility overview

Sex: ALL

Age: 12 Years to 130 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

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
Locations (331)
  • Loma Linda, California, United States
  • Long Beach, California, United States
  • Roseville, California, United States
  • Aurora, Colorado, United States
  • Colorado Springs, Colorado, United States
  • Clearwater, Florida, United States
  • Gainesville, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Plantation, Florida, United States
  • Chicago, Illinois, United States
  • Normal, Illinois, United States
  • Hutchinson, Kansas, United States
  • Shreveport, Louisiana, United States
  • Fall River, Massachusetts, United States
  • Ann Arbor, Michigan, United States
  • Buckley, Michigan, United States
  • Hamtramck, Michigan, United States
  • Lincoln, Nebraska, United States
  • Highland Park, New Jersey, United States
  • West Berlin, New Jersey, United States
  • Albuquerque, New Mexico, United States
  • New York, New York, United States
  • New York, New York, United States
  • Rockville Centre, New York, United States
  • The Bronx, New York, United States
  • The Bronx, New York, United States
  • The Bronx, New York, United States
  • Fargo, North Dakota, United States
  • Cincinnati, Ohio, United States
  • + 301 more on CT.gov