A 4 Week Study to Investigate the Safety and Tolerability of AZD5069 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (CIRRUS)

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Scientific Terminology Chronic Obstructive Pulmonary Disease (COPD); Laymen Terminology Chronic Bronchitis and Emphysema

Treatments: Drug: AZD5069 50mg; Drug: Placebo; Drug: AZD5069 80mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01233232

2010-021217-23 (EudraCT Number)

D3550C00002

Details and patient eligibility

About

The purpose of this study is the evaluate the safety and tolerability of AZD5069 in patients with Chronic Obstructive Pulmonary Disease

Enrollment: 109 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of COPD with symptoms for more than one year before screening
• Body mass index of 18-30 kg/m2 and weight of 50-100kg
• 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
• FEV1 of 30% or above and less than 80% of the predicted normal value post-bronchodilator at screening
• FEV1/FVC less than 70% post-bronchodilator at screening

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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109 participants in 3 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Placebo dose

Treatment:

Drug: Placebo

2

Experimental group

Description:

Treatment arm AZD5069 50mg

Treatment:

Drug: AZD5069 50mg

3

Experimental group

Description:

Treatment arm AZD5069 80mg

Treatment:

Drug: AZD5069 80mg