Tolerability/Safety and Efficacy of Inhaled AZD4818 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (TOP)

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Drug: AZD4818; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00629239

D3540C00005

Details and patient eligibility

About

The purpose of this study is to see if treatment with AZD4818 for four weeks is tolerable, safe and effective in treating COPD and, if so, how it compares with placebo.

Enrollment: 65 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of COPD, with symptoms for more than 1 year
• Current or ex-smokers with a smoking history of at least 10 pack-years (1 pack-year=20 cigarettes/day for 1 year)
• Lung function (FEV1) 40 to 80% of the predicted normal value after using a short acting bronchodilator

Exclusion criteria

• Clinical suspicion of active tuberculosis
• Any current clinically significant respiratory tract disorder other than COPD
• History of current clinically relevant arrhythmia, heart block, ECG abnormalities, or unstable angina

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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65 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

AZD4818

Treatment:

Drug: AZD4818

2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo