A 4-week, Double-Blind, Placebo-Controlled, Randomised, Parallel group, Multi-Centre, Phase IIa Study to Investigate the Tolerability and Safety of 100 mg Oral AZD2423 in Patients with Moderate to Severe COPD. - AZD2423 Safety and Tolerability Study in patients with moderate and severe COPD
- Conditions
- Chronic Obstructive Pulmonary DiseaseMedDRA version: 12.1Level: LLTClassification code 10009033Term: Chronic obstructive pulmonary disease
- Registration Number
- EUCTR2010-020891-43-SK
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
Male or female of non-child bearing potential. Only women of non-child bearing potential are included in the study i.e. women who are permanently or surgically sterilised or post menopausal.
Between 40 and 80 years of age at Visit 1
Clinical diagnosis of COPD (GOLD stage 2 or 3)
FEV1/FVC <70% and FEV1 between 30 and 80% of the predicted normal post-bronchodilator (GOLD stage 2 or 3)
Current or ex-smokers
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Any clinically significant disease or disorder (including history of abnormal immune function) which, in the opinion of the Investigator, may either put the subject at risk or influence the way the drug works
Any lung disease other than COPD, recent respiratory infections which have not resolved fully, active tuberculosis or at risk of reactivation of tuberculosis.
Any abnormal findings in physical examination, blood or urine test results, vital signs or ECG at Visit 1 that may put the subject at risk during the study, affect their ability to take part or influence the results of the study
Immunisation with a live vaccine within 3 months or other vaccination within 30 days before planned start of treatment
Cancer within the last 5 years (other than treated skin cancer or treated cervical cancer)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate the tolerability and safety of AZD2423 in patients with COPD;Secondary Objective: To evaluate the effects of AZD2423 compared to placebo in patients with COPD, as measured by lung function, symptoms, health related quality of life questionnaires and inflammatory mediators (CCL2 and SAA).<br>To investigate the pharmacokinetics of AZD2423 in patients with COPD.<br>;Primary end point(s): Safety and Tolerability of AZD2423
- Secondary Outcome Measures
Name Time Method