Study to Assess the Efficacy and Safety of AZD1981 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (Columbus)

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Moderate to Severe COPD

Treatments: Drug: AZD1981; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00690482

D9831C00001

Details and patient eligibility

About

The purpose of this study is to study efficacy and safety of AZD1981 in patients with Chronic Obstructive Pulmonary Disease

Enrollment: 118 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• FEV1 between 30 and 80% of predicted normal value post-bronchodilator (GOLD stages 2 and 3)
• Clinical diagnosis of COPD

Exclusion criteria

• Other clinically relevant disease or disorders
• Exacerbation of COPD within 30 days

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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118 participants in 2 patient groups, including a placebo group

AZD1981

Experimental group

Description:

AZD1981 Oral tablet, twice daily

Treatment:

Drug: AZD1981

Placebo

Placebo Comparator group

Description:

Placebo Oral tablet, twice daily

Treatment:

Drug: Placebo