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Study of Relationship Between Changes in Inflammation, Lung Function, Symptoms and Medication Use in COPD Patients | Clinical Trials | Clareo Health

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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)

NCT04168216•AstraZeneca

View on ClinicalTrials.gov

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.

Eligibility

Age

40 - 130 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Provision of signed and dated, written ICF prior to any study specific procedures, sampling, and analyses (at Visit 1).
•2. Male or female subjects ≥40 years of age at the time of signing the ICF.
•3. A physician diagnosis of COPD and receiving maintenance treatment with a LABA in combination with an ICS, a LAMA, or both (ie, LABA+ICS, LABA+LAMA, or LABA+ICS+LAMA), for at least 3 months prior to Visit 1.
•4. Physician-documented prescription and subject-confirmed use of an inhaled short-acting bronchodilator (β2 agonists or anticholinergics) as rescue medication prior to study.
•5. Current or ex-smoker with ≥10 pack-year history.
•6. Post-bronchodilator FEV1/FVC \<0.7 recorded in medical history.
•7. Blood eosinophils \>0.1×109 cells/L.
•8. The subject must be able to read, speak, and understand English; and be able to, in the Investigator's judgment, comply with the Study Protocol.
•9. Negative pregnancy test (urine) for female subjects of childbearing potential at Visit 1
•Incusion Criteria for Entry in the Observational Period:
+4 more criteria

Exclusion Criteria

•1. As judged by the Investigator, any evidence of drug/substance abuse which would pose a risk to subject safety, interfere with the conduct of study, have an impact on the study results, or affect the subject's ability to participate in the study.
•2. Concurrent Respiratory Disease: Presence of a known pre-existing, clinically important lung condition other than COPD.
•3. Concurrent diagnosis of asthma (subjects with a history of asthma may be included).
•4. Any disease currently treated with chronic oral/systemic corticosteroids.
•5. Subjects with a history/treatment of malignancy, and which in the Investigator's opinion could compromise the safety of the subject.
•6. Other Concurrent Medical Conditions: Subjects who have known, pre-existing, clinically significant endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic, haematological or any other system abnormalities that are uncontrolled with standard treatment.
•7. Subjects currently treated with eosinophil-depleting medications (ie, mepolizumab, benralizumab), or who have been treated within 5.5 half-lives of eosinophil-depleting medications.
•8. Subjects who have had a COPD exacerbation requiring oral corticosteroids and/or antibiotics in the last 30 days before the run-in period. Subjects will be able to be re-screened 30 days following an exacerbation.
•9. Participation in another clinical study with any marketed or investigational biologic drug within 4 months or 5 half-lives (whichever is longer) prior to Visit 1.
•10. Participation in another clinical study with a non-biologic investigational product or new formulation of a marketed non-biologic drug during the last 30 days prior to Visit 1 that, in the opinion of the Investigator, could impact the results of the current study.
+7 more criteria

Locations (1)

Research Site

Oxford, Oxfordshire, United Kingdom

Key Dates

Start Date

November 30, 2020

Primary Completion Date

June 22, 2022

Completion Date

June 22, 2022

Last Updated

October 2, 2025

Enrollment

ACTUAL participants

Conditions

Pulmonary Disease, Chronic Obstructive

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 2, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

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