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

Inclusion Criteria

• Inclusion Criteria for Entry in the Run-in Period:
• 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:
• 1 Frequent use of SABA (≥200 µg of Ventolin per day, for at least 75% of days in the 3 weeks prior to Visit 2).
• 2 At least 70% compliance with daily FeNO, spirometry, EXACT, and BCSS during the last 3 weeks prior to Visit 2.
• 3 Blood eosinophils >0.1×109 cells/L at Visit 2.
• 4 Negative pregnancy test (urine) for female subjects of childbearing potential at Visit 2.
• 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.
• 11 Subjects with a known hypersensitivity to the treatment or any of the excipients of Duaklir and Ventolin.
• 12 Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
• 13 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).
• 14 Previous entry into the observation period in the present study.
• 15 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.
• 16 As judged by the Investigator, planned hospitalisation/vacation during the study that interferes with study assessments.
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