'Real Life' Monitoring of COPD no ICS Patients | NCT05795712

Studies
'Real Life' Monitoring of COPD no ICS Patients

NCT05795712

Sponsor

Istituti Clinici Scientifici Maugeri SpA

Status

Completed

Last Update Posted

Apr 3, 2023Actual

Enrollment

53Actual

Phase

Not provided

Conditions

COPD

Interventions

Therapy Change from Baseline

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 28, 2017Actual

Primary Completion Date

Sep 7, 2020Actual

Completion Date

Mar 9, 2023Actual

First Submitted Date

Mar 9, 2023

First Submission Date that Met QC Criteria

Mar 21, 2023

First Posted Date

Apr 3, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 21, 2023

Last Update Posted Date

Apr 3, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

53Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Istituti Clinici Maugeri Pneumologia		Tradate	Lombardy	21049	Italy

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

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Browse Branches

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