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A 4 Week, Double Blind, Placebo Controlled, Randomised, Parallel Group, Multicentre, Phase IIa Study to Investigate the Safety and Tolerability of AZD5069 as Oral Capsules in Patients with Moderate to Severe Chronic Obstructive Pulmonary Disease - CIRRUS

A 4 Week, Double Blind, Placebo Controlled, Randomised, Parallel Group, Multicentre, Phase IIa Study to Investigate the Safety and Tolerability of AZD5069 as Oral Capsules in Patients with Moderate to Severe Chronic Obstructive Pulmonary Disease - CIRRUS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2010-021217-23-DE
Enrollment
60
Registered
2010-07-22
Start date
2010-10-22
Completion date
Unknown
Last updated
2012-05-29

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

Conditions

COPD MedDRA version: 13.1 Level: PT Classification code 10009033 Term: Chronic obstructive pulmonary disease System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Product Code: AZD5069 Pharmaceutical Form: Capsule Current Sponsor code: AZD5069 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- Pharmaceutical form of the plac

Sponsors

AstraZeneca AB
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Clinical diagnosis of COPD with symptoms for more than one year before screening 2. Body mass index of 18-30 kg/m2 and weight of 50-100kg 3. Current or ex-smokers with a smoking history of at least 10 pack years (1 pack year = tobacco consumption corresponding to 20 cigarettes smoked per day for one year) at screening 4. FEV1 of 30% or above and less than 80% of the predicted normal value post-bronchodilator at screening 5. FEV1/FVC less than 70% post-bronchodilator at 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Any clinically significant disease or disorder 2. Exacerbation of COPD which was not resolved within 30 days of first dosing 3. Patients who have received live or live-attenuated vaccine in the 2 weeks prior to first dosing 4. Asthma and any current respiratory tract disorder other than COPD which is considered to be clinically significant 5. Disease history suggesting reduced or abnormal immune function other than that related to COPD

Design outcomes

Primary

MeasureTime frame
Main Objective: To evaluate the safety and tolerability of AZD5069 in patients with Chronic Obstructive Pulmonary Disease;Secondary Objective: To investigate the pharmacokinetics of AZD5069 in patients with Chronic Obstructive Pulmonary Disease To investigate the relationship between appropriate measures of AZD5069 exposure and the effect on circulating neutrophils ;Primary end point(s): Safety and tolerability variables (Adverse Events, ECG, physical examination, safety blood samples, vital signs, body temperature, lung function tests)—

Countries

Bulgaria, Germany, Hungary

Outcome results

None listed

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