Effect of Roflumilast on Pulmonary Function and Respiratory Symptoms in Patients With Chronic Obstructive Pulmonary Disease (COPD) (BY217/M2-110)

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease; COPD

Treatments: Drug: Roflumilast

Study type: Interventional

Funder types: Industry

Identifiers

NCT00062582

BY217/M2-110

Details and patient eligibility

About

The aim of the study is to compare the effect of roflumilast and placebo on the lung function in patients with COPD.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

• Clinical diagnosis of COPD (Chronic Obstructive Pulmonary Disease)
• Currently stable COPD with no change in COPD treatment in the prior 4 weeks

Main Exclusion Criteria:

• Clinical diagnosis of asthma
• Poorly controlled COPD
• Regular need for daily oxygen therapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind