Two arm study to compare treatment between rapid and gradual tapering of prednisolone in chronic obstructive pulmonary disease patients.

Rapid vs Gradual Prednisolone Tapering After COPD Exacerbations: A Pragmatic Comparison - NA

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2025/08/092453

Enrollment

Registered

2025-08-05

Start date

Unknown

Completion date

Unknown

Last updated

2025-08-18

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

Conditions

Health Condition 1: J441- Chronic obstructive pulmonary disease with (acute) exacerbation

Interventions

Intervention1: Rapid Tapering Group: Prednisolone 40mg daily for 5 days, then stop abruptly Total duration: 5 days Total prednisolone dose: 200mg Control Intervention1: Gradual Tapering Group: Predn

Eligibility

Inclusion criteria

Inclusion criteria: 1.Confirmed diagnosis of COPD (post-bronchodilator FEV1/FVC less than 0.70) 2.Acute exacerbation requiring hospitalization 3.Prescribed oral prednisolone as part of standard care 4.Clinically stable and ready for discharge 5.Age 40-80 years (inclusive) 6.Ability to provide informed consent Availability for 90-day follow-up

Exclusion criteria

Exclusion criteria: 1.Pneumonia as primary diagnosis 2.Requirement for mechanical ventilation 3.Other significant respiratory conditions (asthma, pulmonary fibrosis, bronchiectasis) 4.Contraindications to corticosteroids 5.Current use of long term oral corticosteroids (more than 10mg prednisolone daily) 6.Severe comorbidities with life expectancy less than 6 months 7.Pregnancy or lactation 8.Inability to comply with study procedures Participation in another interventional study within 30 days

Design outcomes

Primary

Measure	Time frame
Treatment failure at 30 days defined as: Re-exacerbation requiring systemic corticosteroids, OR COPD-related hospitalization, OR COPD-related emergency department visit, OR Death due to COPD exacerbationTimepoint: Baseline at day 0 At day 5 Day 14 Day 30	—

Secondary

Measure	Time frame
1.Time to next COPD exacerbation (90-day follow-up) 2.Corticosteroid-related adverse effects including: Hyperglycemia Hypertension Sleep disturbances Mood changes Weight gain Gastrointestinal symptoms 3.Functional status assessment: Modified Medical Research Council (mMRC) dyspnea scale COPD Assessment Test (CAT) score 4.Healthcare resource utilization: Number of hospitalizations Length of hospital stay Emergency department visits Outpatient visits Medication costs 5.Patient-reported outcomes: Treatment satisfaction Quality of life (EQ-5D-5L) Adherence to treatmentTimepoint: Baseline at day 0 At day 5 Day 14 Day 30	—

Measure

Time frame

1.Time to next COPD exacerbation (90-day follow-up) 2.Corticosteroid-related adverse effects including: Hyperglycemia Hypertension Sleep disturbances Mood changes Weight gain Gastrointestinal symptoms 3.Functional status assessment: Modified Medical Research Council (mMRC) dyspnea scale COPD Assessment Test (CAT) score 4.Healthcare resource utilization: Number of hospitalizations Length of hospital stay Emergency department visits Outpatient visits Medication costs 5.Patient-reported outcomes: Treatment satisfaction Quality of life (EQ-5D-5L) Adherence to treatmentTimepoint: Baseline at day 0 At day 5 Day 14 Day 30

—

Countries

India

Contacts

Public ContactDharmender Singh Lather

Indus International Hospital

attridiksha29@gmail.com9814053459

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026