A Phase IIa Study Assessing the Effects of AZD1236 on Biomarkers in Chronic Obstructive Pulmonary Disease (COPD) Patients (BICO)

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Placebo; Drug: AZD1236

Study type: Interventional

Funder types: Industry

Identifiers

NCT00758706

D4260C00007

Details and patient eligibility

About

The primary aim of this study is to investigate the effects of AZD1236 compared with placebo ("inactive substance") in COPD patients by analysing biomarkers for inflammation and tissue degradation in blood, urine and sputum.

Enrollment: 55 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 symptomatic patients
• 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
• Acute worsening of COPD (exacerbation) 1,5 month prior to study drug administration
• Use of oral or parenteral glucocorticosteroids within 30 days and use of inhaled steroids 14 days prior to the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

55 participants in 2 patient groups, including a placebo group

AZD1236

Experimental group

Description:

oral tablet, 75 mg, twice daily during 6 weeks

Treatment:

Drug: AZD1236

Placebo

Placebo Comparator group

Description:

Dosing to match AZD1236

Treatment:

Drug: Placebo