A 6-month, Randomised, Double-blind, Placebo-controlled, Multi-centre, Parallel-group, Phase II Study with an Optional Safety Extension Treatment Period up to 6 months, to Evaluate the Efficacy, Safety, and Tolerability of 3 Different Doses of AZD5069 Twice Daily as Add-on Treatment to Medium to High Dose Inhaled Corticosteroids (ICS) and Long-acting ß2 Agonists (LABA), in Patients with Uncontrolled, Persistent Asthma

AstraZeneca AB0 个研究点目标入组 564 人开始时间: 2013年3月14日最近更新: 2015年7月10日

适应症

试验速览

暂无简介。

•1. Men and women aged 18 years and above. Females of childbearing potential must use a highly effective contraceptive method plus a condom by their male partner.
•2. Diagnosis of asthma for at least 12 months (GINA 2011)
•3. Uncontrolled persistent asthma, despite treatment with medium to high dose ICS and LABA, and with a history of exacerbations during the last year
•4. Morning prebronchodilator FEV1 of =30% and =85% predicted normal at enrolment
•5. Daily use of medium or high dose ICS (=fluticasone 500 µg or the equivalent daily)
•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 508
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 56

•1. Any clinically significant disease or disorder (including any chronic lower respiratory disease other than asthma) that may put the patient at risk or influence study results
•2. Patients with recurrent, latent, or chronic infections
•3. Active tuberculosis or latent tuberculosis without completion of an appropriate course of treatment or prophylactic treatment
•4. Significant lower respiratory tract infection not resolved within 30 days prior to enrolment
•5. Current smoker or smoking history of more than 20 pack years

发起方