Severe exacerbation of chronic obstructive pulmonary disease (COPD) MedDRA version: 21.1 Level: LLT Classification code 10010953 Term: COPD exacerbation System Organ Class: 100000004855
Conditions
Interventions
Trade Name: TRIMBOW 87 micrograms/5 micrograms/9 micrograms
Pharmaceutical Form: Inhalation solution
INN or Proposed INN: FORMOTEROL
CAS Number: 73573-87-2
Concentration unit: µg microgram(s)
Concentr
Sponsors
University Hospital Mutua de Terrassa
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this study is to compare the usual treatment for severe exacerbations vs inhaled extrafine triple therapy with formoterol, glycopyrronium, and beclomethasone in a single device (TRIMBOW) in addition to the usual treatment, during the first three days of hospitalization in patients previously treated with LABA + LAMA, LABA + ICs, or LABA + LAMA + ICs. The primary endpoint is changes in expiratory flow limitation evaluated with the difference between inspiratory and expiratory reactance measured by impulse oscillometry, between the first and the third day of hospitalization, before the first daily administration of SABA and SAMA (with or without triple therapy according to randomization);Secondary Objective: 1. Changes in expiratory flow limitation, between the first and the third day of hospitalization, 30 minutes after the first daily administration of SABA and SAMA (with or without triple therapy according to randomization). 2. Changes in dyspnea measured with the validated Spanish version of the Dyspnea-12 questionnaire and a 10 cm. visual analogue dyspnea scale, before the first daily administration of bronchodilators, between the first and the third day of hospitalization. 3. Length of hospital stay. 4. Required rescue doses of SABA and SAMA. 5. Readmissions 1 month after hospital discharge.;Primary end point(s): The primary endpoint is a change in expiratory flow limitation, before first morning treatment with bronchodilators, and a minimal washout period of 12 hours without long-acting bronchodilators, between the first and third days after randomisation. Expiratory flow limitation will be measured with an impulse oscillometer device (Resmon Pro Full) and calculated as the difference between inspiratory reactance (Xrsinsp) and expiratory reactance (Xrsexp) (?Xrs =Xrsinsp - Xrsexp).;Timepoint(s) of evaluation of this end point: 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Changes in expiratory flow limitation between the first and third days of hospitalizations measured 30 minutes after the first daily administration of bronchodilators. 2. Changes in dyspnea questionnaires completed by patient before first morning bronchodilator treatment between the first and third days after randomisation. 3. Days of hospitalization number of short-acting bronchodilator rescue doses. 4. Readmissions 1 month after hospital discharge.;Timepoint(s) of evaluation of this end point: 1 year | — |
Countries
Spain
Contacts
Public ContactComplex chronic patient care unit
University Hospital Mutua of Terrassa
Outcome results
None listed