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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2010-020891-43-SK
Enrollment
60
Registered
2010-08-17
Start date
2010-10-07
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease MedDRA version: 12.1 Level: LLT Classification code 10009033 Term: Chronic obstructive pulmonary disease

Interventions

Product Name: AZD2423 Product Code: AZD2423 Pharmaceutical Form: Tablet Current Sponsor code: AZD2423 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceut

Sponsors

AstraZeneca AB
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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 =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 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)

Design outcomes

Primary

MeasureTime frame
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). To investigate the pharmacokinetics of AZD2423 in patients with COPD. ;Primary end point(s): Safety and Tolerability of AZD2423—

Countries

Bulgaria, Slovakia

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026