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The treatment failure and clinical efficacy comparison of budesonide metered-dose inhaler and systemic steroid in acute COPD exacerbation

The treatment failure and clinical efficacy comparison of budesonide metered-dose inhaler and systemic steroid in acute COPD exacerbation

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20220926002
Enrollment
124
Registered
2022-09-26
Start date
2022-08-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD with acute moderate to severe exacerbation (according to GOLD guideline 2022) COPD, chronic obstructive pulmonary exacerbation, exacerbation

Interventions

Budesonide Metered-Dose inhaler (MDI) 3 puff every 6 hours for 5 days,Dexamethasone 10-20 mg/day or Prednisolone 30-40 mg/day for 5 days
Experimental Drug,Active Comparator Drug
Budesonide,Standard

Sponsors

Department of Emergency Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age at least 18 years old Diagnosed with COPD by spirometry or clinical symptoms according to GOLD guideline 2022 Presents to emergency department with acute moderate to severe exacerbation according to GOLD guideline 2022 Improves after initial treatment with bronchodilator and 1 dose of intravenous dexamethasone Eligible for Metered-Dose Inhaler used

Exclusion criteria

Exclusion criteria: Acute respiratory failure Hypotension despite sufficient of intravenous fluid and vasopressor Pneumothorax Cardiac arrest Tracheostomy History of systemic corticosteroid used within 1 month prior Long-term oxygen therapy

Design outcomes

Primary

MeasureTime frame
Treatment failure 30 days Revisit, worsening symptom, respiratory failure

Secondary

MeasureTime frame
Admission rate 7 days Percent,Intubation rate 7 days Percent,COPD assessment test (CAT) score At arrival Mean or median,COPD assessment test (CAT) score 7 days Mean or median

Countries

Thailand

Contacts

Public ContactUsapan Surabenjawong

Sirairaj Hospital Faculty of Medicine

usapan.sur@mahidol.ac.th0840995693

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026