Reduce Trial

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Short-term vs Conventional Glucocorticoid Therapy in Acute Exacerbations of Chronic Obstructive Pulmonary Disease: The REDUCE Randomized Clinical Trial | Chronic Obstructive Pulmonary Disease | JAMA | JAMA Network

Summary:

This Non-inferiority Randomized controlled trial looked at the duration of corticosteroids for the treatment of acute exacerbations of COPD. They randomized 314 patients in 5 Swiss teaching hospitals.

PICOTT:

Population: COPD patients with acute exacerbation

Intervention: 5 days (Short Term) systemic steroids

Comparison: 14 days (Conventional) systemic steroids.

Outcomes: Time to next exacerbation within 180 days. No difference in time to death, the composite of both or recovery of lung function. Multiple exploratory outcomes.

Type of Question: Therapy

Type of Study: RCT – non-inferiority.

Interpretation:

In this RCT the authors showed non-inferiority of a shorter course of steroids (5 days), compared to a conventional 14-day course for COPD patients. There was no difference in the primary outcome of time to next exacerbation or any of the measured exploratory outcomes, including mortality, side effects, time to exacerbation, recovery of lung function. There was a shorter hospitalization LOS in the intervention, as well as less exposure to steroids.

Overall Risk of bias:  LOW

• There was a difference in gender distribution in both groups. But no other issues. Likely random error.

• Non-inferiority trial – with limitations inherent to the study design. Will probably not a big issue if there is a small difference in exacerbations.

• Patients, caregivers, outcome assessors, data collectors, the biostatistician, and all other investigators remained blinded. Unclear if the treating team was blinded.

• Small number of events for mortality and other exploratory outcomes, might be different if new studies are performed with larger numbers of patients / events.

• The outcomes were analyzed both per protocol and intention-to-treat, which is the correct way in non-inferiority trials.

Context: 

At the time of the trial, there was no standard steroid treatment for COPD and patients were exposed to long treatments or tapers.

Teaching points:

·         Non-inferiority trials

·         Per protocol analysis

Verdict:

Somewhat settled - Might change with more data