Oscillometry in the COPD Exacerbator Phenotype With Triple Inhaled Therapy Study

NCT06931899 | Not Yet Recruiting

• 1 other identifier: EOM018/23
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this observational study is to determine the effectiveness of inhaled corticosteroids in patients with chronic obstructive pulmonary disease (COPD) and frequent worsening of their respiratory symptoms by using a device called an oscillometer. This instrument is capable of measuring bronchial obstruction and air trapping in the lungs through vibrations during normal breathing. The main question it seeks to answer is: Could oscillometry be useful in assessing the effectiveness of inhaled corticosteroids in patients with COPD exacerbations, in terms of bronchial obstruction and air trapping in the lungs? Patients who choose to participate will undergo oscillometry testing and complete standard COPD questionnaires during three follow-up visits spread over three months.

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Keywords

Oscillometry; COPD; Inhaled corticosteroids

Outcome Measures

Primary Outcomes (1)

• Oscillometric results

  R19, R5, R5-19, X19, X5, ∆Xrs (cmH2O/(L/s)

  on each of the 3 visits (baseline, week 4, week 12)

Secondary Outcomes (4)

• Spirometric results

  initial and at visit 3 (baseline and week 12)

• COPD Assessment Test (CAT)

  on each of the 3 visits (baseline, week 4, week 12)

• Test of Adherence of Inhalers (TAI)

  on each of the 3 visits (baseline, week 4, week 12)

• Spirometric results (forced expiratory volume in 1 second to forced vital capacity ratio)

  initial and at visit 3 (baseline and week 12)

Study Arms (3)

Central bronchial obstruction

Oscillometry classification.

Peripheral bronchial obstruction

Oscillometry classification.

Pulmonary hyperinflation

Oscillometry classification.

Eligibility Criteria

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

Study Population

Patients with exacerbating COPD from the pulmonology clinics of 6 hospitals in Catalonia, Spain.

You may qualify if:

• Age over 18 years.
• Diagnosis of COPD.
• Severe-moderate COPD measured by FEV1 and stable.
• COPD exacerbations (COPD exacerbations).
• Blood eosinophils \>100 cells/mL in prior laboratory tests.
• Patient agrees to participate in the study and signs the informed consent form.

You may not qualify if:

• COPD in the last 4 weeks, with use of antibiotics or systemic corticosteroids.
• Chronic lung disease other than COPD.
• Severe heart failure, with frequent decompensation (in cases of mild decompensation or onset without severe heart disease, do not include the patient within 3 months of decompensation).
• Active neoplastic processes.
• Severe renal failure.
• \. ALT greater than 2.5 times the upper limit of normal. 6. Poorly controlled insulin-dependent diabetes or involvement of 1 or more organs.
• \. Positive COVID-19 test (do not include until 3 months after diagnosis by ART or COVID-19 PCR).
• \. Previous treatment with ICS in the last 4 months.

Sponsors & Collaborators

• Hospital Universitari de Bellvitge: lead
• Institut d'Investigació Biomèdica de Bellvitge: collaborator
• Chiesi España, S.A.U.: collaborator

Study Sites (1)

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

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

Central Study Contacts

Yuliana Pascual González, Pulmonology (PI)

CONTACT

0034937003626; ypascual@bellvitgehospital.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pneumologist

Study Record Dates

• First Submitted: April 3, 2025
• First Posted: April 17, 2025
• Study Start: April 1, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: It will be available until the completion of data inclusion in the REDCAP database (approximately one year).
• Access Criteria: Only the principal investigators of each center will have access to the REDCAP database.

Locations

ES (1)