Multi-centre Study to Assess the Efficacy and Safety of AZD5423 in COPD Patients on a Background Therapy of Formoterol

Inclusion Criteria:

• Provision of signed and dated informed consent prior to conducting any study specificprocedures

• Men or women aged ≥ 40 years

• Men or post-menopausal or surgically sterile women. Women will be consideredpost-menopausal if they have been amenorrheic for at least 12 months, and have afollicle stimulating hormone (FSH) plasma concentration within the postmenopausalrange as defined by the laboratory. Male patients should be willing to use barriercontraception, i.e. condom (with spermicide) from the day of dosing until at least 5weeks after the last dose with the study drug.

• Clinical diagnosis of COPD for more than 1 year at Visit 1, according to GOLDguidelines

• Current maintenance therapy with LABA and/or LAMA, ICS/LABA or ICS plus LAMAcombination

• Current or ex-smokers with a smoking history equivalent to at least 10 pack years (1pack year = 20 cigarettes smoked per day for one year)

• Post-bronchodilator FEV1 ≥40 and ≤ 80% of the predicted normal value

• Post-bronchodilator FEV1/FVC <0,7

• Reversibility of airway obstruction according to reversibility test performed at visit 2, defined as an increase in FEV1 of ≥10% relative baseline after inhalation of intotal 400 μg salbutamol or 1 mg terbutaline sulphate

• Chest radiography (not older than 12 months at Visit 2) not showing any pathologicalchanges that would make the patient unsuitable for inclusion as judged by theInvestigator

• Able to read and write and use the electronic devices (eDiary and electronicspirometry)

• Ability to complete an eDiary correctly. Baseline diary data had to be recorded for atleast 8 (any 8) of the last 10 days of the run-in period to accept patients forrandomized treatment (Randomisation Criteria at Visit 3).

• Provision of informed consent for genetic sampling and analyses. If a patient declinesto participate in the pharmacogenetic research, there will be no consequence or lossof benefit to the patient. The patient will not be excluded from other aspects of thestudy described in the Clinical Study Protocol (CSP), as long as they consent (Inclusion criteria for patients taking part in the pharmacogenetic research)

Exclusion Criteria:

• Significant disease or disorder (eg, cardiovascular, pulmonary other than COPD,gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic,malignant, psychiatric, major physical impairment) which, in the opinion of theinvestigator, may either put the patient at risk because of participation in thestudy, or influence the results of the study, or the patient's ability to participatein the study

• Any clinically relevant abnormal findings in clinical chemistry, haematology,urinalysis, physical examination, pulse, blood pressure or ECG at Visit 2, which, inthe opinion of the investigator, may put the patient at risk because of his/herparticipation in the study

• Requirement for long term oxygen therapy

• An exacerbation of COPD, defined as use of oral or parenteral glucocorticosteroids ororal/parenteral antibiotics or hospitalisation related to COPD within 6 weeks of Visit 2

• Participation in or scheduled for an intensive COPD rehabilitation program

• Known or suspected hypersensitivity to study therapy or excipients of the study drug

• History of current alcohol or drug abuse or any condition associated with poorcompliance as judged by the investigator

• Plasma donation within one month of screening or any blood donation/blood loss >500 mLduring the 3 months prior to screening.

• Participation in any clinical study with an investigational drug or new formulation ofa marketed drug in the 3 months prior to Visit 2

• Planned in-patient surgery or hospitalisation during the study

• Previous randomisation of treatment into the present study

• Involvement in the planning and conduct of the study (applies to both AstraZenecastaff or staff at the study site)

• Previous allogeneic bone marrow transplant (Exclusion criteria for patients takingpart in the pharmacogenetic research)

• Non-leukocyte depleted whole blood transfusion within 120 days of the date of thegenetic sample collection (Exclusion criteria for patients taking part in thepharmacogenetic research)