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Observational Study of Obstructive Lung Disease (NOVELTY)

NCT02760329 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 12255

Last updated 2024-10-03

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Blood draw

Biomarkers analyses

PROCEDURE

Urine

Biomarker analyses

PROCEDURE

Lung function measurements

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

PROCEDURE

Fractional Exhaled Nitric Oxide (FENO)

Measures level of exhaled nitric oxide.

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Eligibility

Min Age
12 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-25
Primary Completion
2023-05-31
Completion
2023-05-31

Countries

  • United States
  • Argentina
  • Australia
  • Brazil
  • Canada
  • China
  • Colombia
  • Denmark
  • France
  • Germany
  • Italy
  • Japan
  • Mexico
  • Netherlands
  • Norway
  • South Korea
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02760329 on ClinicalTrials.gov