NCT04168216

Study of Relationship Between Changes in Inflammation, Lung Function, Symptoms and Medication Use in COPD Patients

A 12-week Exploratory Study to Characterise the RelatiOnship Between Changes in InflammatoRy Markers, Lung Function, Symptoms And ReLiever Use in Chronic Obstructive Pulmonary Disease Patients (CORAL)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 31 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 40 Years – 130 Years
• Healthy volunteers: Not accepted

Summary

The intention with the study is to have a better understanding of what happens to COPD patients' symptoms, lung function and markers of inflammation over 12 weeks. This information will increase the understanding of COPD and how to design new treatments for COPD in the future.

Detailed description

This is a Phase IV, open-label, single-arm, single-site study. The purpose of this exploratory study is to gain longitudinal insights into the relationships between the inflammatory profile, symptoms, lung function, and reliever use in subjects with chronic obstructive pulmonary disease (COPD). The study will include a minimum of 8 clinic visits and consist of a Screening Visit (Visit 1), a 4-week run-in period, a Baseline Visit (Visit 2) and a 12-week observational period, including 6 visits scheduled every 2 weeks. To standardise the use of COPD medications all subjects will receive maintenance Duaklir and reliever Ventolin for the duration of the study. During the observational period, additional visits may occur if subjects experience a worsening of their COPD symptoms. For each individual subject, the duration of participation in the study will be 16 weeks. Estimated study duration is approximately 20 months including approximately 50 patients.

Conditions

• Pulmonary Disease, Chronic Obstructive

Timeline

• Start date: 2020-11-30
• Primary completion: 2022-06-22
• Completion: 2022-06-22
• First posted: 2019-11-19
• Last updated: 2025-10-02

Locations

1 site across 1 country: United Kingdom