tility of inhaled triple therapy to improve expiratory flow limitation in severe COPD exacerbations.

Phase 1

• Conditions: Severe exacerbation of chronic obstructive pulmonary disease (COPD); MedDRA version: 21.1Level: LLTClassification code 10010953Term: COPD exacerbationSystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2021-001429-34-ES
• Lead Sponsor: niversity Hospital Mutua de Terrassa

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-06
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Patients 40 years and older.
2. Accepting participation in the study and signing informed consent.
3. Previous diagnosis of COPD confirmed by spirometry.
4. Currently requiring hospitalization for COPD exacerbation.
5. Domiciliary treatment in stable phase with triple therapy (LABA + LAMA + ICs), combined bronchodilation (LABA + LAMA) or (LABA + ICs) at least two months before current exacerbation.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

1. Myocardial infarction or unstable angina event in the last month or at time of admission.
2. Uncontrolled arrhythmias (flutter, atrial fibrillation, or ventricular arrhythmias) that, in the opinion of the investigators, contraindicate administration of ß-mimetics or anticholinergics.
3. COPD exacerbation requiring invasive or non-invasive mechanical ventilation or intensive care unit admission on the first day of hospitalization.
5. Inability to perform the inhaled treatment (SABA and SAMA with or without TRIMBOW) correctly with the Aerochamber Plus Flow chamber with a facial mask (cognitive impairment, delirium, altered level of consciousness).
6. Inability to perform respiratory function tests with the impulse oscillometer device (Resmon ProFull) or inability to complete dyspnea questionnaires.
7. Pregnancy or being of fertile age.
8. Severe renal impairment (CKD-EPI <15 mL/min/1.73m2) or dialysis.
9. Pneumonia, acute pulmonary edema, pneumothorax as the main causes of hospital admission.
10. Bronchiectasis or asthma as a predominant disease.
11. Hospitalization for severe exacerbation of COPD in the previous month.
12. History of lung reduction or lung transplant surgery.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified