'Real Life' Monitoring of COPD no ICS Patients

Completed

• Conditions: COPD

• Registration Number: NCT05795712
• Lead Sponsor: Istituti Clinici Scientifici Maugeri SpA

Brief 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.

Study Timeline

• Study Start: 2017-06-28
• Primary Completion: 2020-09-07
• Status Verified: 2023-03
• Study Completion: 2023-03-09
• Study First Submitted: 2023-03-09
• Study First Submitted QC: 2023-03-21
• Last Update Submitted: 2023-03-21
• Study First Posted: 2023-04-03
• Last Update Posted: 2023-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

• COPD diagnosis according to GOLD 2017 recommendations in clinical stability phase
• Post bronchodilator FEV1 ≥50 and ≤80
• Both smoker and ex-smoker
• Patients on LABA or LABA/LAMA therapy
• Patients also on ICS therapy discontinued at least 30 days after enrolment
• Patient able to cooperate with the required procedures
• Patient who has signed the informed consent

Exclusion Criteria

• • Acute respiratory episode treated with antibiotics and/or steroids in the lower 4 weeks prior to enrolment
• Patients on roflumilast therapy
• Any exacerbation of COPD within 1 month after visit 1. A patient must not have had any hospitalisation for COPD within 6 months prior to visit 1.
• Comorbidities. History or current evidence of a clinically significant comorbidity or history of a positive test for HIV, hepatitis B or hepatitis C.
• History of adverse reactions including immediate or delayed hypersensitivity to any beta2-agonists,
• sympathomimetic drugs or any intranasal, inhaled or systemic corticosteroid therapy known or suspected sensitivity to the components of the inhalers used in the study (e.g. lactose in dry powder inhalers).
• Use of immunosuppressive drugs within 12 weeks prior to visit 1 and during the study, including use of systemic corticosteroids.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants which introduced ICS therapy after 24 month of follow up	24 months	The aim of our study will be to evaluate in patients with mild-to-moderate COPD the role of inflammation in the patient's therapeutic management and follow-up.

Trial Locations

Locations (1)

Istituti Clinici Maugeri Pneumologia; 🇮🇹 Tradate, Lombardia, Italy