Effect on Structural Changes in Airways, Measured by MSCT, of Twice Daily 60mg AZD9668 for 12 Weeks in Chronic Obstructive Pulmonary Disease (COPD) Patients

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Drug: Placebo; Drug: AZD9668

Study type: Interventional

Funder types: Industry

Identifiers

NCT01054170

D0520C00014

Details and patient eligibility

About

The primary objective of the study is to evaluate structural changes effected by AD9668 in the airways of adults with Chronic Obstructive Pulmonary Disease (COPD) by Multi-Slice Computed Tomography (MSCT)

Enrollment: 52 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of COPD with symptoms over 1 year
• FEV1/FVC < 70% and FEV1 >= 40 and < =70 % of predicted post-bronchodilator
• Ex-smokers for at least 12 months

Exclusion criteria

• Past history or current evidence of clinically significant heart disease
• Current diagnosis of asthma
• Worsening of COPD requiring hospitalisation and/or treatment with antibiotics and/or an increase in inhaled steroid dose and/or oral steroids within 4 weeks of study visit 1b

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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52 participants in 2 patient groups, including a placebo group

AZD9668

Experimental group

Treatment:

Drug: AZD9668

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo