None listed
Conditions
Interventions
week run-in period with oral prednisolone 30 mg/day (or
equivalent), administered once daily in the morning in addition to the usual prescribed COPD
maintenance treatment (at least ICS and LABA)
Sponsors
AstraZeneca AB,
Eligibility
Sex/Gender
All
Age
40 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1.Provision of signed and dated written informed consent prior to any study specific procedures 2. Male and females aged 40 - 85 years 3. Females must have a negative pregnancy test at Visit 1 5. A weight of ≥50 kg (measured at Visit 1) 6. Clinical diagnosis of COPD for more than 1 year at Visit 1, according to the GOLD 2014 guidelines 7. Stable COPD maintenance treatment with at least ICS and LABA for at least 2 months prior to enrolment (Visit 1), to be continued unchanged during the study 8. A post-bronchodilator FEV1/FVC <0.70 and a post-bronchodilator FEV1 ≤70% of the predicted normal value (at Visit 2) Documented history of 2 or more moderate or severe COPD exacerbations 10. Current or ex-smokers with a smoking history of at least 10 pack-years (1 pack year = 20 cigarettes smoked per day for one year) (at Visit 1) 11. Able to read and write and to comply with the study procedures 12. Ability to complete an eDiary correctly. Baseline diary data recorded for any 14 morning or evening diaries in the last 10 days of the run-in period to be eligible for randomisation (Visit 3) 13. Demonstrated ability to inhale with required inhalation flow using the Flow Indicator (at Visit 2 and 3). 14. Demonstrated ability to inhale from the ADI device according to the provided instructions (at Visit 3)
Exclusion criteria
Exclusion criteria: 1.Involvement in the planning and conduct of the study 2. Previous randomisation to treatment in the present study 3. Participation in another clinical study with any novel investigational medicinal product within 3 months 4. Previously intake of any p38 inhibitor (same class as AZD7624) 5. Participation in, or scheduled for an intensive COPD rehabilitation programme at any time during the study 6. Planned in-patient surgery or hospitalisation during the study 7. Significant disease or disorder other than COPD 8. Asthma as a primary or main diagnosis according to the Global Initiative for Asthma (GINA) guidelines 9. Any clinically relevant abnormal findings in clinical chemistry, haematology and 10. Creatine Kinase (CK) above the upper reference range 11. Any clinically relevant abnormal findings in physical examination 12. Any positive result on screening for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody and human immunodeficiency virus (HIV) 13. History or family history of muscle diseases 14. Abnormal vital 15. Prolonged QTcF >450 16. Unstable angina pectoris or stable angina pectoris 17. History of severe allergy/hypersensitivity 18. Any exacerbation within 6 weeks
Countries
Argentina, Chile, Germany, Netherlands, South Africa, United States
Contacts
Public ContactUrsula Rodriguez Frias
ASTRAZENECA PERU S.A.
Outcome results
None listed