NCT06931899Not yet recruiting
Oscillometry in the COPD Exacerbator Phenotype With Triple Inhaled Therapy Study
Usefulness of Oscillometry in Assessing the Effectiveness of Inhaled Corticosteroides in Patients With COPD Exacerbator Phenotype
Source: ClinicalTrials.gov · Last updated 17 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 63 (estimated)
- First submitted
- 3 Apr 2025
- Start date
- Apr 2025
- Primary completion date
- Apr 2026
- Lead sponsor
- Hospital Universitari de Bellvitge
- Diseases
- COPD
- NCT number
- NCT06931899
What you commit to
- Study type: Observational
- Planned participants: 63
- From Apr 2025 to the primary completion date, Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- COPD in the last 4 weeks, with use of antibiotics or systemic corticosteroids.
Other illness
- 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).
Lab values
- 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.
Other
- Active neoplastic processes.
Who the study is looking for
- Age over 18 years.
- Diagnosis of COPD.
- Severe-moderate COPD measured by FEV1 and stable.
- 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.
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitari de Bellvitge Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.