'Real Life' Monitoring of COPD no ICS Patients

COPD Clinical Trial

— COPDnoICS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05795712
• Other study ID #: 2126 CE
• Status: Completed
• Start date: June 28, 2017
• Est. completion date: March 9, 2023

Study information

• Verified date: March 2023
• Source: Istituti Clinici Scientifici Maugeri SpA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: March 9, 2023
• Est. primary completion date: September 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• COPD

Intervention

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

Locations

Country	Name	City	State
Italy	Istituti Clinici Maugeri Pneumologia	Tradate	Lombardia

Sponsors (1)

Lead Sponsor	Collaborator
Istituti Clinici Scientifici Maugeri SpA

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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