Effectiveness of Roflumilast in Treating COPD in Greek Patients
Clinical Study for the Effectiveness of Roflumilast Treatment in COPD Greek Patients Based on Standard Clinical Practice. An Observational, Non-interventional Multicenter Study.
Elpen Pharmaceutical Co. Inc. · NCT05426915
This study tests if roflumilast can help Greek patients with severe COPD and chronic bronchitis feel better and have fewer flare-ups, even when other treatments aren't working well.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 750 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Elpen Pharmaceutical Co. Inc. (industry) |
| Locations | 1 site (Athens, Attica) |
| Trial ID | NCT05426915 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the effectiveness of roflumilast, a phosphodiesterase 4 inhibitor, in managing severe COPD associated with chronic bronchitis in Greek patients. The study focuses on patients who experience frequent exacerbations despite receiving bronchodilator and inhaled corticosteroid therapy. By targeting systemic and lung inflammation, roflumilast aims to improve patient outcomes by reducing inflammatory mediators and enhancing lung function. The study will assess the drug's impact on neutrophil levels and overall COPD management according to standard clinical practices.
Who should consider this trial
Good fit: Ideal candidates for this study are adult patients with severe COPD and a history of frequent exacerbations who are already on bronchodilator and ICS therapy.
Not a fit: Patients who are currently taking theophylline or do not meet the inclusion criteria for severe COPD will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for patients with severe COPD, potentially reducing exacerbations and improving quality of life.
How similar studies have performed: Previous studies have shown positive outcomes with roflumilast in COPD management, indicating that this approach is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria 1. Adult patients indicated for maintenance treatment of severe COPD associated with chronic bronchitis with a history of frequent exacerbations in addition to bronchodilator / ICS therapy. 2. Consent and compliance with the therapies and study procedures. Exclusion criteria According to the contraindications of the SPC of the product. Patients should not take theophylline.
Where this trial is running
Athens, Attica
- Sotiria Hospital — Athens, Attica, Greece (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Copd, COPD Exacerbation