Observational study of obstructive lung disease (NOVELTY): A NOVEL observational longiTudinal studY on patients with a diagnosis or suspected diagnosis of asthma and/or COPD to describe patient characteristics, treatment patterns and the burden of illness over time and to identify phenotypes and endotypes associated with differential outcomes that may support future development of personalised treatment strategies

This Study is
No Longer Enrolling

Description

This study is a multi-country, multicenter, 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.

Details
Age

Adult

Eligibility

? Diagnosis, or suspected diagnosis (patients with respiratory symptoms consistent with asthma or COPD) of asthma and/or COPD, according to clinicians judgement ? Age >12 years ? Willing and able to sign written, informed consent (or having a responsible, legally authorised representative acting on patients behalf) ? Enrolment from an active clinical practice

? Patients who participated in any respiratory interventional trial during the 12 months prior to, 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

Type of Study

Observational

Locations

University of Colorado Hospital

Study ID

Protocol Number: 17-0706

Categories

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