Budesonide MDI vs systemic steroids in COPDAE: a non-inferiority trial

Phase 3

• Conditions: Chronic obstructive pulmonary disease with mild to moderate acute exacerbation; COPD; COPDAE; budesonide MDI; systemic steroids; ED; prednisolone; dexamethasone

• Registration Number: TCTR20201005006
• Lead Sponsor: Routine to research unit, Faculty of medicine, Siriraj hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-05
• Study Completion: 2021-11-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 120

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

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 < 7.25 and/or PaCO2 > 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
%predicted FEV1 improvement after steroid treatment at 2 weeks after 2 weeks Portable spirometer: Vitalograph COPD6

Secondary Outcome Measures

Name	Time	Method
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