Chronic obstructive pulmonary disease with mild to moderate acute exacerbation COPD COPDAE budesonide MDI systemic steroids ED prednisolone dexamethasone
Conditions
Interventions
Dexamethasone IV 10-
15 mg/day divided in 2-
3 doses then if d/c switch to Prednisolone PO 40-
60 mg/d continued for a total of 5 days
according to GOLD 2020 recommendation,Budesonide MDI (200 mcg/puff) 3 puff q 6hr via spacer,
continued for a total of 5 days
Active Comparator Drug,Experimental Drug
Systemic steroids,Budesonide MDI
Sponsors
Routine to research unit, Faculty of medicine, Siriraj hospital
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. patients who have already been diagnosed as "COPD" 2. patients who come to ED , Siriraj hospital with acute exacerbation of COPD within 1 hour after initial treatment
Exclusion criteria
Exclusion criteria: 1. patients with signs of respiratory failure according to 1 or more of these criteria 1.1 attending physician's decision to intubate, or support ventilation with NIV/BIPAP 1.2 RR > 30/min, accessory muscles uses, cyanosis, patients who need FiO2 > 0.4 to keep SpO2 > 92% 1.3 ABG pH 50 mmHg 1.4 alteration fo consciousness 1.5 new onset limb edema or cardiac arrhythmia or hypotension requiring vasopressors 2. Presence of pneumothorax 3. Cardiac arrest or history of cardiac arrest 4. Patient with tracheostomy 5. Patients who need home oxygen therapy or CPAP at home 6. Patients who cannot follow study methods effectively or safely for example one who can't tolerate MDI with spacer, can't do the spirometry test 7.Patients who have other life-threatening or other emergency conditions requiring immdediate stabilization 8. Patients or attending physician decline participation 9. Patients who has already been treated with IV or Oral steroids within 1 month prior to inclusion 10. Patients whom the attending physician deem not requiring steroid therapy 11. Patients who has history of COPDAE with respiratory failure or ICU admission 12. Patients who are allergic to study drugs 13. Patients who have concomittant heart or lung diseases eg. Chronic heart failure, Chronic coronary artery disease, pneumonia, bronchiectasis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| %predicted FEV1 improvement after steroid treatment at 2 weeks after 2 weeks Portable spirometer: Vitalograph COPD6 | — |
Secondary
| Measure | Time frame |
|---|---|
| no. of patients requiring hospital admission after steroid treatment in 24 hour 24 hr percentage of patient in each treatment arm, review medical record,no. of patients who deteriorate to respiratory failure after steroid treatment within 24 hours 24 hr percentage fo patient in each treatment arm, review medical record,%predictedFEV1 changes after steroid treatment at 3 and 6 hours 3 hr and 6 hr Portable spirometry: Vitalograph COPD6,treatment effect to patient's quality of life at 2 week post treatment 2 weeks mMRC, CAT score,Adverse effects of steroid treatment including short term (hyperglycemia) and long term (eg. UGIB... 6 hr - 2 weeks patients follow up visit interview, review medical records, POCT glucose at 6 hr post treatment | — |
Countries
Thailand
Contacts
Public ContactChok Limsuwat
Faculty of medicine, Siriraj hospital
Outcome results
None listed