Evaluation of Clinical Effectiveness of Roflumilast in Routine Practice, in Chronic Obstructive Pulmonary Disease (COPD) Patients in Greece (ATLAS)
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About
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.
Full description
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.
Enrollment
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Volunteers
Inclusion and exclusion criteria
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
Trial design
2,577 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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