Study In Subjects With COPD (Chronic Obstructive Pulmonary Disease)

A Randomized, 24-week, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety and Tolerability of ARIFLO® (15mg BID) in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00103922

Enrollment

600

Registered

2005-02-18

Start date

2004-11-30

Completion date

2007-01-31

Last updated

2016-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

smokers cough

Brief summary

This study was designed to determine if the investigational drug is effective and safe in individuals with COPD (chronic pulmonary disease)

Interventions

DRUGcilomilast

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

Inclusion criteria

* Diagnosis of COPD and a history of cigarette smoking.

Exclusion criteria

* Significant heart or lung disease not associated with COPD. * Significant stomach or intestinal disease.

Design outcomes

Primary

Measure	Time frame
measure of lung function and quality of life in patients with COPD	—

Secondary

Measure	Time frame
exacerbations in patients with COPD	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026