A phase IIa, randomised, multi-centre, double blind, placebo-controlled 3 periods, crossover study to investigate the efficacy, pharmacokinetics, safety and tolerability of inhaled AZD8871 administered once daily for two weeks in patients with moderate to severe COPD

AstraZeneca AB0 个研究点目标入组 42 人开始时间: 2016年10月5日最近更新: 2018年2月12日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: AstraZeneca AB
入组人数: 42

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•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 <70% based on the value reached after inhalation of salbutamol (400 µg) at Visit 2. If criterion is not met, the test can be repeated at the latest, up to Day 14.
•7. Patient with post-bronchodilator FEV1 that must be =40% and <80% predicted normal value at Visit 2. If criterion is not met, the test can be repeated at the latest, up to Day 14.
•8. Patient who fulfils reversibility criteria to salbutamol at Visit 2. Reversibility is defined as =12% and =200 mL increase in FEV1 after inhalation of 4 puffs of salbutamol (400 µg). If the criterion is not met, the test can be repeated at the latest, up to Day 14.
•9. Patient is willing and, in the opinion of the Investigator, able to change current COPD therapy as required by the protocol and willing to use ipratropium QID (if needed, during run-in and wash-out periods) with or without ICS for maintenance therapy of COPD and rescue medication salbutamol (as needed ) from Visit 1 up Visit 11.
•10. Patient is free from any clinically active disease other than COPD that may impact study outcome, as determined by medical history, physical examination, laboratory testing, and 12-lead ECG findings, at Screening.
•11. Patient is willing to remain at the study centre as required per-protocol to complete all visit assessments.
•12. Patient with body mass index (BMI) <40 kg/m2 at the time of screening.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 26
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 16

排除标准

•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.

研究者

发起方

AstraZeneca AB

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