Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The AURA Study (BY217/M2-124)

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Drug: Roflumilast; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00297102

BY217/M2-124

Details and patient eligibility

About

The aim of the study is to investigate the effect of roflumilast on exacerbation rate and pulmonary function in patients with chronic obstructive pulmonary disease (COPD). Roflumilast will be administered orally once daily in the morning at one dose level. The study duration will last up to 56 weeks. The study will provide further data on safety and tolerability of roflumilast.

For additional information (for US patients only) see www.COPDSTUDY.net or dial 866-788-2673 (toll free).

Enrollment: 1,523 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

• COPD patients having at least one exacerbation within last year
• FEV1/FVC ratio (post-bronchodilator) ≤ 70%
• FEV1 (post-bronchodilator) ≤ 50% of predicted

Main Exclusion Criteria:

• COPD exacerbation not resolved at first baseline visit
• Diagnosis of asthma and/or other relevant lung disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,523 participants in 2 patient groups, including a placebo group

Roflumilast

Active Comparator group

Description:

500 mcg, once daily, oral administration in the morning

Treatment:

Drug: Roflumilast

Placebo

Placebo Comparator group

Description:

once daily

Treatment:

Drug: Placebo