Safety/Tolerability Study With AZD1236 in Chronic Obstructive Pulmonary Disease (COPD) Patients (CERA)

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Placebo; Drug: AZD1236

Study type: Interventional

Funder types: Industry

Identifiers

NCT00758459

D4260C00003

Details and patient eligibility

About

The primary aim of this study is to investigate the tolerability and safety of AZD 1236 compared with placebo ("inactive substance") in COPD patients by assessment of Adverse Events, vital signs and laboratory safety assessments.

Enrollment: 74 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of COPD for 1 month
• Men or postmenopausal women
• Spirometry values indicating reduced lung function
• Smoking history equivalent to using 20 cigarettes a day for 10 years

Exclusion criteria

• Any current respiratory tract disorders other than COPD
• Requirement for regular oxygen therapy
• Use of oral or parenteral glucocorticosteroids within 30 days prior to the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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74 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: AZD1236

2

Placebo Comparator group

Treatment:

Drug: Placebo