Pulmonary Disease, Chronic ObstructiveCORALNCT04168216
Study of Relationship Between Changes in Inflammation, Lung Function, Symptoms and Medication Use in COPD Patients
An observational study of Pulmonary Disease, Chronic Obstructive, run by AstraZeneca at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 130 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- How many people
- 31 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Nov 2020to 22 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will include patients diagnosed with symptomatic COPD and blood eosinophil count >0.1×109 cells/L, who are receiving maintenance treatment with a long-acting β2 agonist (LABA) in combination with ICS and/or a long-acting muscarinic antagonist (LAMA) and require use of an inhaled short-acting bronchodilator (β2 agonists or anticholinergics) as rescue medication. The study will include both current and former smokers (with at least 10 pack-year history) and intends to recruit a maximum of 30% current smokers.
Who may be able to join
- Provision of signed and dated, written ICF prior to any study specific procedures, sampling, and analyses (at Visit 1).
- Male or female subjects ≥40 years of age at the time of signing the ICF.
- 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.
- Physician-documented prescription and subject-confirmed use of an inhaled short-acting bronchodilator (β2 agonists or anticholinergics) as rescue medication prior to study.
- Current or ex-smoker with ≥10 pack-year history.
- Post-bronchodilator FEV1/FVC <0.7 recorded in medical history.
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- Blood eosinophils >0.1×109 cells/L.
- 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.
- Negative pregnancy test (urine) for female subjects of childbearing potential at Visit 1
- Incusion Criteria for Entry in the Observational Period:
- Frequent use of SABA (≥200 µg of Ventolin per day, for at least 75% of days in the 3 weeks prior to Visit 2).
- At least 70% compliance with daily FeNO, spirometry, EXACT, and BCSS during the last 3 weeks prior to Visit 2.
- Blood eosinophils >0.1×109 cells/L at Visit 2.
- Negative pregnancy test (urine) for female subjects of childbearing potential at Visit 2.
Who cannot join
- 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.
- Concurrent Respiratory Disease: Presence of a known pre-existing, clinically important lung condition other than COPD.
- Concurrent diagnosis of asthma (subjects with a history of asthma may be included).
- Any disease currently treated with chronic oral/systemic corticosteroids.
- Subjects with a history/treatment of malignancy, and which in the Investigator's opinion could compromise the safety of the subject.
- 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.
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- Subjects currently treated with eosinophil-depleting medications (ie, mepolizumab, benralizumab), or who have been treated within 5.5 half-lives of eosinophil-depleting medications.
- 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.
- 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.
- 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.
- Subjects with a known hypersensitivity to the treatment or any of the excipients of Duaklir and Ventolin.
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
- Judgment by the Investigator that the subject should not participate in the study if the subject is unlikely to complete the observational period (eg, literacy, substance abuse, life-threatening comorbidity).
- Previous entry into the observation period in the present study.
- For women only - currently pregnant (confirmed with positive pregnancy test), breast-feeding or planned pregnancy during the study. Women of childbearing potential not using acceptable contraceptive measures, as judged by the Investigator.
- As judged by the Investigator, planned hospitalisation/vacation during the study that interferes with study assessments.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
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.
Read the 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
- Keywords
- Chronic Obstructive Pulmonary Disease, COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammation data will be plotted for each subject over the 12 weeks of the study to provide an understanding of the temporal dynamics of the data.
Inflammation:
FeNO (daily) Blood eosinophils, CRP, and EDN (fortnightly) Sputum eosinophils and neutrophils (weekly)
Measured: 12 weeks
Lung function data will be plotted for each subject over the 12 weeks of the study to provide an understanding of the temporal dynamics of the data.
Lung function:
FEV1, PEF, Oscillometry (daily)
Measured: 12 weeks
Symptoms data (BCSS) will be plotted for each subject over the 12 weeks of the study to provide an understanding of the temporal dynamics of the data.
Symptoms:
BCSS (daily)
Measured: 12 weeks
Symptoms data (E-RS) will be plotted for each subject over the 12 weeks of the study to provide an understanding of the temporal dynamics of the data.
Symptoms:
E-RS (daily)
Measured: 12 weeks
Symptoms data (VAS-COPD) will be plotted for each subject over the 12 weeks of the study to provide an understanding of the temporal dynamics of the data.
Symptoms:
VAS-COPD (daily)
Measured: 12 weeks
Symptoms data (SGRQ) will be plotted for each subject over the 12 weeks of the study to provide an understanding of the temporal dynamics of the data.
Symptoms:
SGRQ (fortnightly)
Measured: 12 weeks
Symptoms data (CAT) will be plotted for each subject over the 12 weeks of the study to provide an understanding of the temporal dynamics of the data.
Symptoms:
CAT (fortnightly)
Measured: 12 weeks
Reliever use data will be plotted for each subject over the 12 weeks of the study to provide an understanding of the temporal dynamics of the data.
Reliever use:
Ventolin® use (daily)
Measured: 12 weeks
Secondary outcomes (8)
Inflammation data will be plotted for a subject around a COPD worsening event to provide an understanding of the temporal dynamics of the data.
Inflammation:
FeNO (daily) Blood eosinophils, CRP, and EDN (fortnightly) Sputum eosinophils and neutrophils (weekly)
Measured: 12 weeks
Lung function data will be plotted for a subject around a COPD worsening event to provide an understanding of the temporal dynamics of the data.
Lung function:
FEV1, PEF, Oscillometry (daily)
Measured: 12 weeks
Symptoms data (BCSS) will be plotted for a subject around a COPD worsening event to provide an understanding of the temporal dynamics of the data.
Symptoms:
BCSS (daily)
Measured: 12 weeks
Symptoms data (E-RS) will be plotted for a subject around a COPD worsening event to provide an understanding of the temporal dynamics of the data.
Symptoms:
E-RS (daily)
Measured: 12 weeks
Symptoms data (VAS-COPD) will be plotted for a subject around a COPD worsening event to provide an understanding of the temporal dynamics of the data.
Symptoms:
VAS-COPD (daily)
Measured: 12 weeks
Symptoms data (SGRQ) will be plotted for a subject around a COPD worsening event to provide an understanding of the temporal dynamics of the data.
Symptoms:
SGRQ (fortnightly)
Measured: 12 weeks
Symptoms data (CAT) will be plotted for a subject around a COPD worsening event to provide an understanding of the temporal dynamics of the data.
Symptoms:
CAT (fortnightly)
Measured: 12 weeks
Reliever use data will be plotted for a subject around a COPD worsening event to provide an understanding of the temporal dynamics of the data.
Reliever use:
Ventolin® use (daily)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start30 Nov 2020
- Primary completion22 Jun 2022
- Study completion22 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Oxford
- Responsible party
- Sponsor
- Investigators
- Mona Bafadhel, Professor, Principal investigator, Respiratory Department Churchill Hospital Old Road OX3 7LE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04168216
- Sponsor's protocol ID
- D6930R00002
- Acronym
- CORAL
- Status last verified
- Sep 2025
- First submitted
- 11 Oct 2019
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized indyvidual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment.: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. AZ will be accepting requests for IDP, but this does not mean all requests will be shared
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT04168216
- Acronym / sponsor ID
- CORAL / D6930R00002
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Chronic Obstructive Pulmonary Disease, COPD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- University of Oxford
- Study start
- 30 Nov 2020 (actual)
- Primary completion
- 22 Jun 2022 (actual)
- Study completion
- 22 Jun 2022 (actual)
- First posted
- 19 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include patients diagnosed with symptomatic COPD and blood eosinophil count >0.1×109 cells/L, who are receiving maintenance treatment with a long-acting β2 agonist (LABA) in combination with ICS and/or a long-acting muscarinic antagonist (LAMA) and require use of an inhaled short-acting bronchodilator (β2 agonists or anticholinergics) as rescue medication. The study will include both current and former smokers (with at least 10 pack-year history) and intends to recruit a maximum of 30% current smokers.
Key inclusion criteria (14 listed)
- Provision of signed and dated, written ICF prior to any study specific procedures, sampling, and analyses (at Visit 1).
- Male or female subjects ≥40 years of age at the time of signing the ICF.
- 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.
- Physician-documented prescription and subject-confirmed use of an inhaled short-acting bronchodilator (β2 agonists or anticholinergics) as rescue medication prior to study.
- Current or ex-smoker with ≥10 pack-year history.
Key exclusion criteria (17 listed)
- 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.
- Concurrent Respiratory Disease: Presence of a known pre-existing, clinically important lung condition other than COPD.
- Concurrent diagnosis of asthma (subjects with a history of asthma may be included).
- Any disease currently treated with chronic oral/systemic corticosteroids.
- Subjects with a history/treatment of malignancy, and which in the Investigator's opinion could compromise the safety of the subject.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Inflammation data will be plotted for each subject over the 12 weeks of the study to provide an understanding of the temporal dynamics of the data.
Time frame: 12 weeks
Inflammation: FeNO (daily) Blood eosinophils, CRP, and EDN (fortnightly) Sputum eosinophils and neutrophils (weekly)
Lung function data will be plotted for each subject over the 12 weeks of the study to provide an understanding of the temporal dynamics of the data.
Time frame: 12 weeks
Lung function: FEV1, PEF, Oscillometry (daily)
Symptoms data (BCSS) will be plotted for each subject over the 12 weeks of the study to provide an understanding of the temporal dynamics of the data.
Time frame: 12 weeks
Symptoms: BCSS (daily)
Symptoms data (E-RS) will be plotted for each subject over the 12 weeks of the study to provide an understanding of the temporal dynamics of the data.
Time frame: 12 weeks
Symptoms: E-RS (daily)
Symptoms data (VAS-COPD) will be plotted for each subject over the 12 weeks of the study to provide an understanding of the temporal dynamics of the data.
Time frame: 12 weeks
Symptoms: VAS-COPD (daily)
Symptoms data (SGRQ) will be plotted for each subject over the 12 weeks of the study to provide an understanding of the temporal dynamics of the data.
Time frame: 12 weeks
Symptoms: SGRQ (fortnightly)
Symptoms data (CAT) will be plotted for each subject over the 12 weeks of the study to provide an understanding of the temporal dynamics of the data.
Time frame: 12 weeks
Symptoms: CAT (fortnightly)
Reliever use data will be plotted for each subject over the 12 weeks of the study to provide an understanding of the temporal dynamics of the data.
Time frame: 12 weeks
Reliever use: Ventolin® use (daily)
8 secondary outcomes
Inflammation data will be plotted for a subject around a COPD worsening event to provide an understanding of the temporal dynamics of the data.
Time frame: 12 weeks
Lung function data will be plotted for a subject around a COPD worsening event to provide an understanding of the temporal dynamics of the data.
Time frame: 12 weeks
Symptoms data (BCSS) will be plotted for a subject around a COPD worsening event to provide an understanding of the temporal dynamics of the data.
Time frame: 12 weeks
Symptoms data (E-RS) will be plotted for a subject around a COPD worsening event to provide an understanding of the temporal dynamics of the data.
Time frame: 12 weeks
Symptoms data (VAS-COPD) will be plotted for a subject around a COPD worsening event to provide an understanding of the temporal dynamics of the data.
Time frame: 12 weeks
Symptoms data (SGRQ) will be plotted for a subject around a COPD worsening event to provide an understanding of the temporal dynamics of the data.
Time frame: 12 weeks
Symptoms data (CAT) will be plotted for a subject around a COPD worsening event to provide an understanding of the temporal dynamics of the data.
Time frame: 12 weeks
Reliever use data will be plotted for a subject around a COPD worsening event to provide an understanding of the temporal dynamics of the data.
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- CSR SynopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized indyvidual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment.: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. AZ will be accepting requests for IDP, but this does not mean all requests will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mona Bafadhel, Professor principal investigator
Respiratory Department Churchill Hospital Old Road OX3 7LE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, Chronic Obstructive, run by AstraZeneca at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammation data will be plotted for each subject over the 12 weeks of the study to provide an understanding of the temporal dynamics of the data. (time frame: 12 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.