Chronic Obstructive Pulmonary Disease (COPD) MedDRA version: 19.1 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855
Conditions
Interventions
Product Name: AZD8871
Product Code: AZD8871
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: AZD8871
CAS Number: 1648550-37-1
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient who provided of informed consent prior to any study-specific procedures 2. Male or female 40 to 80 years of age (both inclusive) at Screening (Visit 1). A female is eligible to enter and participate in the study if she is of non-childbearing potential. 3. Male patient should use a condom and spermicide to prevent pregnancy and drug exposure of a partner, regardless of the gender or childbearing potential of the partner first administration of the IP until 3 months after the last administration of the IP. 4. COPD Diagnosis: Patient with an established clinical history of COPD for more than 1 year at Screening, according to the GOLD 2016 COPD guidelines. 5. Tobacco Use: Patient is a current or former smoker with a history of =10 pack-years of cigarette smoking. A former smoker is defined as one who has stopped smoking for at least 6 months prior to Screening. 6. Patient with post-bronchodilator FEV1/FVC ratio =65 years) yes F.1.3.1 Number of subjects for this age range 16
Exclusion criteria
Exclusion criteria: 1. Patient previously enrolled in the present study. 2. Patient has significant diseases other than COPD, ie, disease or condition or an abnormality in laboratory, ECG, medical history or physical examination which, in the opinion of the Investigator, may put the patient at risk because of participation in the study or may influence either the results of the study or the patient's ability to participate in the study. 3. Childbearing potential female, pregnant or lactating. 4. Patient who, in the opinion of the Investigator, has a current diagnosis of asthma. 5. Patient has alpha-1 antitrypsin deficiency as the cause of COPD. 6. Patient has other active pulmonary disease such as active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, idiopathic interstitial pulmonary fibrosis, primary pulmonary hypertension, or uncontrolled sleep apnoea. Allergic rhinitis is not exclusionary. 7. Lung surgery for volume reduction or lung transplantation: Patient has undergone lung volume reduction surgery, lobectomy, or bronchoscopic lung volume reduction (endobronchial blockers, airway bypass, endobronchial valves, thermal vapour ablation, biological sealants, massive pulmonary embolism and airway implants) within 1 year of Screening (Visit 1). 8. Patient is using nocturnal positive pressure (eg, continuous positive airway pressure or bi level positive airway pressure). Patient is using any non-invasive positive pressure ventilation device. Note: A patient using continuous positive airway pressure or bi level positive airway pressure for Sleep Apnoea Syndrome is allowed in the study. 9. Patient who had 2 or more exacerbations of COPD (moderate or severe in intensity) within the last year prior to Screening (see Section 3.9 for definition of exacerbation of COPD) 10. Patient has been hospitalised due to poorly controlled COPD within 3 months of Screening. 11. Patient has acute worsening of COPD that requires treatment with corticosteroids or antibiotics in the 6 week interval prior to Screening (Visit 1), or during the Screening Period (between Visits 1 and 3). 12. Patient has had lower respiratory tract infections that required antibiotics within 6 weeks prior to Screening. 13. Patient cannot perform acceptable spirometry, ie, meet American Thoracic Society (ATS)/European Respiratory Society (ERS) acceptability criteria. 14. Patient has changed their smoking status (ie, start or stop smoking) or initiation of a smoking cessation program within 6 weeks of Screening. 15. Patient has participated in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Screening or who will enter the acute phase of a pulmonary rehabilitation program during the study. A patient in the maintenance phase of a pulmonary rehabilitation program is not to be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of inhaled AZD8871 in patients with moderate to severe COPD patients.;Secondary Objective: To investigate the pharmacokinetics of AZD8871 and its metabolites after multiple dose administration of AZD8871 in patients with moderate to severe COPD.;Primary end point(s): Change from baseline in Trough FEV1 on Day 15.;Timepoint(s) of evaluation of this end point: Day 15 | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Day 1, Day 14; Secondary end point(s): On serial PK sampling days, the following PK parameters will be calculated for AZD8871 and its metabolites LAS191861 and LAS34850 when applicable. Day 1: Cmax, tmax, AUClast, AUC(0-24) Day 14: Cmax, tmax, AUClast, AUC(0-24), Cavg, %Fluctuation, Rac(Cmax) and Rac(AUC(0-24)) | — |
Countries
Germany, United Kingdom
Contacts
Public ContactClinical Trial Information Desk
AstraZeneca AB
Outcome results
None listed