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Three-day vs five-day oral prednisolone for acute exacerbation in chronic obstructive pulmonary disease

Three-day vs five-day oral prednisolone for acute exacerbation in chronic obstructive pulmonary disease: A Double-blinded Randomized Non-inferior Controlled Trial.

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20200327002
Enrollment
Unknown
Registered
2020-03-27
Start date
2020-02-20
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

We exclude patients who have a history of asthma&#44

Interventions

They will treat by dexamethasone 4 mg intravenous q6hr for 24hr then three&#45
day vs five&#45
day oral prednisolone according to tracking number by Intervention group received 0.5 mg. per kilogram of oral prednisone daily for three days&#44
followed by placebo for two&#45
days.,Control Group received 0.5 mg. per kilogram of oral prednisone daily for five days.
Placebo Comparator Drug,Active Comparator Drug
Prednisolone,Prednisolone

Sponsors

khon kaen hospital
Lead Sponsor
kamalasai hospital
Collaborator

Eligibility

Sex/Gender
All
Age
20 Years to No maximum

Inclusion criteria

Inclusion criteria: Thai patients who were 20-year-old or older who diagnosed acute exacerbation of COPD and history of the ratio of FEV1 to forced vital capacity (FVC) lower than 70% as evaluated by postbronchodilator spirometry, history of FEV1 lower than 80% as evaluated by postbronchodilator spirometry and smoking history of 10 pack-years or more.

Exclusion criteria

Exclusion criteria: We exclude patients who have a history of asthma, ischemic heart disease, radiological diagnosis of pneumonia, congestive heart failure or other lung diseases, history of any cancer disease, pregnancy or lactation, need continuous immunosuppressive (e.g. prednisolone, dexamethasone, methylprednisolone, IVIG), need a ventilator, inability to follow up and inability to give written informed consent.

Design outcomes

Primary

MeasureTime frame
relapse of acute exacerbation in chronic obstructive pulmonary disease 1 month yes or no of relapse

Secondary

MeasureTime frame
oxygen saturation 1 month pulse oxymeter,failure treatment 1 month count number,symptom's free days 1 month count number,FEV1 1 month spirometer

Countries

thailand

Contacts

Public ContactPotcharapol Samart

Khon kaen hospital

potcharapolsamart@gmail.com0985867012

Outcome results

None listed

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