A Single-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Phase IIa Study to Investigate the Effects of 100mg AZD2423 as an oral tablet in Subjects with Mild COPD Following Segmental Endobronchial LPS Instillation. - Investigation of the effect of oral treatment with 100mg AZD2423 in subjects with mild COPD.

Conditions: Chronic Obstructive Pulmonary Disease (COPD)
MedDRA version: 13.1Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2010-020141-26-DE

Lead Sponsor: AstraZeneca AB

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

For inclusion in the study subjects should fulfil the following criteria:

1- 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.
2- = 40 years of age at Visit 1
3- Clinical diagnosis of COPD (GOLD stage 1)
4- FEV1 = 80% of the predicted normal post-bronchodilator at Visit 1 (GOLD stage 1)
5- FEV1/FVC <70% post-bronchodilator at Visit 1 (GOLD stage 1)

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 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

Subjects should not enter the study if any of the following exclusion criteria are fulfilled:

1- Any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk or influence the way the drug works
2- Any clinically relevant 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 or take part or influence the results of the study
3- A past history or current indication of renal (kidney) failure
4- Subjects at risk of active tuberculosis or of disease reactivation
5- Subjects who have had any clinically significant illness within 4 weeks before Visit 2 (start of treatment)