'Real Life' Monitoring of COPD no ICS Patients

NCT05795712 | Completed

• 1 other identifier: 2126 CE
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Therapy Change from Baseline OTHER

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

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead

Study Sites (1)

Istituti Clinici Maugeri Pneumologia

Tradate, Lombardy, 21049, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

induced sputum blood samples

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Antonio Spanevello

Study Record Dates

• First Submitted: March 9, 2023
• First Posted: April 3, 2023
• Study Start: June 28, 2017
• Primary Completion: September 7, 2020
• Study Completion: March 9, 2023
• Last Updated: April 3, 2023

Record last verified: 2023-03

Locations

IT (1)