CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 12,255 enrolled
Drug / intervention
Blood draw +3 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02760329
NCT02760329N/ACompleted

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.

AstraZeneca·observational·Posted May 3, 2016·Updated Oct 3, 2024

In Brief

An observational study evaluating Blood draw, Urine, and 2 other interventions for Asthma and 2 related conditions. Completed, enrolled 12,255 participants across 331 sites in 19 countries.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Australia, Brazil, Canada, China, Colombia, Denmark, France, Germany, Italy, Japan, Mexico, Netherlands, Norway, South Korea, Spain, Sweden, United Kingdom, United States
CollaboratorsParexel

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedMay 3, 2016
Enrollment StartJul 25, 2016
Primary CompletionMay 31, 2023
TodayJul 2, 2026
Enrollment to primary: 6.9 yearsPosted 10.2 years ago

Interventions

Blood drawprocedure

Biomarkers analyses

Urineprocedure

Biomarker analyses

Lung function measurementsprocedure

FEV1, FVC, PEF, FEF25-75%, IC, calculated FEV1/FVC ratio and calculated FEV1 % predicted

Fractional Exhaled Nitric Oxide (FENO)procedure

Measures level of exhaled nitric oxide.