Clinical trial NCT05795712: 'Real Life' Monitoring of COPD no ICS Patients
Official title: 'Real Life' Monitoring of COPD Patients According to the 2017 GOLD Recommendations: Role of Bronchial Inflammation in Patient Management.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Lead sponsor: Istituti Clinici Scientifici Maugeri SpA
Sponsor class: OTHER
First posted: 2023-04-03
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with COPD diagnosis in therapy with LABA or LAMA or LABA/LAMA

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants which introduced ICS therapy after 24 month of follow up
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tradate
country: Italy
facility: Istituti Clinici Maugeri Pneumologia
state: Lombardia
Study officials:
References: