Ireland
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Starting soon Observational

Oscillometry in the COPD Exacerbator Phenotype With Triple Inhaled Therapy Study

NCT06931899 · tracked via the Priya Life Science Spain tracker
Phase
Observational
Started
2025-04
Last updated
2025-04-17

Condition(s) studied

COPD (Chronic Obstructive Pulmonary Disease)

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Age over 18 years. 2. Diagnosis of COPD. 3. Severe-moderate COPD measured by FEV1 and stable. 4. Patient receiving dual bronchodilation therapy (LABA/LAMA) for at least the last 4 months prior to study inclusion and meeting clinical criteria to begin triple inhaled therapy. 5. COPD exacerbations (COPD exacerbations). 6. Blood eosinophils \>100 cells/mL in prior laboratory tests. 7. Patient agrees to participate in the study and signs the informed consent form. Exclusion Criteria: 1. COPD in the last 4 weeks, with use of antibiotics or systemic corticosteroids. 2. Chronic lung disease other than COPD. 3. 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). 4. Active neoplastic processes. 5. Severe renal failure. 5\. ALT greater than 2.5 times the upper limit of normal. 6. Poorly controlled insulin-dependent diabetes or involvement of 1 or more organs. 7\. Positive COVID-19 test (do not include until 3 months after diagnosis by ART or COVID-19 PCR). 8\. Previous treatment with ICS in the last 4 months.

Primary outcome measure(s)

  • Oscillometric results — on each of the 3 visits (baseline, week 4, week 12)
    R19, R5, R5-19, X19, X5, ∆Xrs (cmH2O/(L/s)

Trial sites (1)

FacilityCityRegionStatus
Hospital Universitari de Bellvitge L'Hospitalet de Llobregat Barcelona
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06931899 on ClinicalTrials.gov ↗ ← All trials in Spain