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CompletedNCT05795712COPDnoICSUpdated Apr 3, 2023

'Real Life' Monitoring of COPD no ICS Patients

An observational study in COPD, sponsored by Istituti Clinici Scientifici Maugeri SpA. Completed at 1 site in Italy. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-04-03.

Sponsored by Istituti Clinici Scientifici Maugeri SpA · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
53
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • COPD
03

In context

Lead sponsor

Istituti Clinici Scientifici Maugeri SpA is the lead sponsor of 113 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
53 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Interventions

  • OtherTherapy 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

06

What researchers measure

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.

    Time frame: 24 months

07

Study locations

1 site
  • Istituti Clinici Maugeri Pneumologia
    Tradate, Lombardia 21049, Italy
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 3, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05795712
Lead sponsor
Istituti Clinici Scientifici Maugeri SpA
Responsible party
RicercaTradate (Professor Antonio Spanevello, Istituti Clinici Scientifici Maugeri SpA) — Principal investigator
First posted
Apr 3, 2023
Start date
Jun 28, 2017
Primary completion
Sep 7, 2020
Completion
Mar 9, 2023
Last update
Apr 3, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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