Status:
NOT_YET_RECRUITING
Oscillometry in the COPD Exacerbator Phenotype With Triple Inhaled Therapy Study
Lead Sponsor:
Hospital Universitari de Bellvitge
Collaborating Sponsors:
Institut d'Investigació Biomèdica de Bellvitge
Chiesi España, S.A.U.
Conditions:
COPD (Chronic Obstructive Pulmonary Disease)
Eligibility:
All Genders
18+ years
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 res...
Detailed Description
Chronic obstructive pulmonary disease (COPD) is the most prevalent chronic respiratory disease worldwide, estimated at around 12% in Spain and 17.3% in Catalonia, despite significant underdiagnosis of...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
April 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT06931899
Start Date
April 1 2025
End Date
August 1 2026
Last Update
April 17 2025
Active Locations (1)
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1
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain, 08907