Evaluation of Clinical Effectiveness of Roflumilast in Routine Practice, in Chronic Obstructive Pulmonary Disease (COPD) Patients in Greece

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

2577 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

Study Completion Date

2013-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study was to examine the characteristics of patients selected for treatment with roflumilast and the effectiveness and safety of roflumilast in patients with severe or very severe COPD treated in Hospital and outpatient specialist ward settings in Greece.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The drug being observed in this study is called roflumilast. Roflumilast is used to treat people who have chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis with a history of worsening symptoms. This study looked at side effects and the lung function of people who take roflumilast. The study enrolled 2577 patients who were already prescribed roflumilast as an add on to bronchiodilator treatment by their healthcare provider. This multi-centre trial was conducted in Greece. The overall time to participate in this study was up to 6 months. Participants were evaluated during routine appointments with their healthcare provider.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Obstructive Pulmonary Disease

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Drug therapy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Roflumilast

Roflumilast will be administered according to the prescribing information of the approved label in Greece.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Be diagnosed with COPD at stages 3 or 4 according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines.
* Have the clinical phenotype of chronic bronchitis with cough and sputum production (with or without emphysema).
* Already be receiving treatment for their disease (inhaled bronchodilators (long-acting beta2-agonists (LABA), long-acting muscarinic antagonists (LAMA), short-acting beta2-agonists (SABA), short-acting muscarinic antagonist (SAMA)), inhaled corticosteroids (ICS), combination of inhaled bronchodilators and corticosteroids.
* Be aged over 40 years

Exclusion Criteria

• None

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

AstraZeneca AstraZeneca

Role: STUDY_DIRECTOR

AstraZeneca

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RO-2455-401-GR

Identifier Type: -

Identifier Source: org_study_id