Status:
UNKNOWN
Clinical Study for the Effectiveness of Roflumilast Treatment in COPD Greek Patients Based on Standard Clinical Practice.
Lead Sponsor:
Elpen Pharmaceutical Co. Inc.
Conditions:
Copd
COPD Exacerbation
Eligibility:
All Genders
18-90 years
Brief Summary
Preferred pharmacological management for COPD according to the GOLD guidelines are the long-acting anticholinergic LAMAs (Long-Acting / Short-Acting Muscarinic Antagonists), and long-acting β 2-Agonis...
Detailed Description
Roflumilast is a phosphodiesterase 4 (PDE4) inhibitor, a non-steroidal, anti-inflammatory active substance intended to target both systemic inflammation and COPD-related lung inflammation. The mechani...
Eligibility Criteria
Inclusion
- Inclusion criteria
- 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.
- 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.
Exclusion
Key Trial Info
Start Date :
May 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2024
Estimated Enrollment :
750 Patients enrolled
Trial Details
Trial ID
NCT05426915
Start Date
May 1 2023
End Date
May 1 2024
Last Update
September 7 2023
Active Locations (1)
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1
Sotiria Hospital
Athens, Attica, Greece