'Real Life' Monitoring of COPD no ICS Patients (COPDnoICS)

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

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.

Study Overview

• Status: Completed
• Conditions: COPD
• Intervention / Treatment: Other: Therapy Change from Baseline

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 Type: Observational
• Enrollment (Actual): 53

Contacts and Locations

Study Locations

• Italy
  • Lombardia
    • Tradate, Lombardia, Italy, 21049
      • Istituti Clinici Maugeri Pneumologia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with COPD diagnosis in therapy with LABA or LAMA or LABA/LAMA

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants which introduced ICS therapy after 24 month of follow up	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.	24 months

Collaborators and Investigators

• Sponsor: Istituti Clinici Scientifici Maugeri SpA

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2017
• Primary Completion (Actual): September 7, 2020
• Study Completion (Actual): March 9, 2023

Study Registration Dates

• First Submitted: March 9, 2023
• First Submitted That Met QC Criteria: March 21, 2023
• First Posted (Actual): April 3, 2023

Study Record Updates

• Last Update Posted (Actual): April 3, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2126 CE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No