NCT05795712

'Real Life' Monitoring of COPD no ICS Patients

'Real Life' Monitoring of COPD Patients According to the 2017 GOLD Recommendations: Role of Bronchial Inflammation in Patient Management.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 53 (actual)
• Sponsor: Istituti Clinici Scientifici Maugeri SpA · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study will be to assess in patients with mild-to-moderate COPD the role of inflammation in the patient's therapeutic management and follow-up.

Detailed description

Studies have already shown that the risk of severe exacerbations in patients with COPD is associated with eosinophilic inflammation (1) and that patients with this type of inflammation have an increased risk of exacerbations if ICS administration is discontinued (2), but this indication does not appear in the latest GOLD recommendations to date. The aim of the study will be to evaluate in patients with mild-to-moderate COPD the role of induced sputum and peripheral inflammation in the patient's therapeutic management and follow-up. For this purpose, the investigators will assess inflammation at the bronchial and systemic level by induced sputum and haemochrome at time 0 (recruitment), after 6,12, 18 and 24 months after therapy administration according to the updated 2017 GOLD recommendations.

Conditions

• COPD

Interventions

Type	Name	Description
OTHER	Therapy Change from Baseline	The patient will be followed up from the point of view of therapy according to symptoms and flare-ups irrespective of systemic or peripheral eosinophil assessment

Timeline

• Start date: 2017-06-28
• Primary completion: 2020-09-07
• Completion: 2023-03-09
• First posted: 2023-04-03
• Last updated: 2023-04-03

Locations

1 site across 1 country: Italy