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. 2018 Mar 19;2018(3):CD006897. doi: 10.1002/14651858.CD006897.pub4

Leuppi 2013.

Methods STUDY DESIGN: parallel
LOCATION, NUMBER OF CENTRES: Switzerland, recruited in 5 teaching hospitals
DURATION OF STUDY: 14 days, follow‐up 180 days
Participants N SCREENED: 717
N RANDOMISED: 314
N COMPLETED: 296
M = 188, F = 123
BASELINE DETAILS:
Gender F: SCS ≤ 7 days 33%/SCS > 7 days 47% (P value 0.02)
CURRENT SMOKERS: SCS ≤ 7 days 49%/SCS > 7 days 40%
LTOT: SCS ≤ 7 days 16%/SCS > 7 days 11%
AGE: SCS ≤ 7 days: 69.8 (11.3)/SCS > 7 days 69.8 (10.6)
FEV1 % predicted: SCS ≤ 7 days 32 (SD 15)/SCS > 7 days 31 (SD 13)
PYH SMOKING median years: SCS ≤ 7 days 50/SCS > 7 days 45
INCLUSION CRITERIA: age > 40 years, smoking history ≥ 20 pack‐years
EXCLUSION CRITERIA: history of asthma, FEV1/FVC ratio > 0.7 (post bronchodilator), radiological diagnosis of pneumonia, estimated survival < 6 months (due to severe co‐morbidity), pregnancy or lactation, inability to give written consent
Interventions SCS ≤ 7 days: 5 days: day 1: IV methylprednisolone 40 mg, days 2 to 5: oral prednisolone 40 mg, days 6to 14: placebo
SCS > 7 days: 14 days: day 1: IV methylprednisolone 40 mg, days 2 to 14: oral 40 mg prednisolone
Co‐interventions:

  1. Broad‐spectrum antibiotics (7 days)

  2. Inhaled, nebulised, short‐acting bronchodilator (4 to 6 times/d prn)

  3. Inhaled glucocorticoids and β2 agonist (twice daily)

  4. Inhaled tiotropium 18 µg (once daily)


Physiotherapy, supplemental oxygen and ventilator support (administered according to international guidelines)
 Additional glucocorticoids administered at the discretion of treating physicians
TREATMENT PERIOD: 5 days vs 14 days
TREATMENT SETTING: inpatient after presentation to ED. Treated as outpatients after discharge direct from ED; INT: 12 participants (7.7%); CONTROL: 13 participants (8.4%)
FOLLOW‐UP PERIOD: 180 days
Outcomes FEV1 % predicted
Adverse effects: (infection, hyperglycaemia, hypertension, other)
Relapse
Duration of hospital stay
Mortality
Quality of life (bronchitis‐associated quality‐of‐life score, 0 to 6 = worst)
Patient‐reported overall performance (visual analogue scale)
Dyspnoea (Medical Research Council Dyspnoea score 1 to 5 = worst)
Notes More women in the short‐term arm (46.5% vs 32.7%; P value 0.02). ISRCTN19646069.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomly assigned to one of two treatment regimens using a centralised, computerbased
 randomisation procedure with fixed blocks of 6. Study subjects randomised after stratification.
Allocation concealment (selection bias) Low risk Each study subject randomly assigned to receive a prepared set of study medication, consisting of two drug vials. The drugs prepared prior to the initiation of the study and packed by the Pharmacology Department, University Hospital, Basel, according to a randomisation list.
Blinding (performance bias and detection bias) 
 All outcomes Low risk Patients, caregivers, outcome assessors, data collectors, the biostatistician, and all other investigators remained blinded to group allocation until the primary analysis was completed.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Three patients excluded after randomisation in a blinded fashion because of erroneous initial COPD diagnoses. Data from remaining 311 patients were used for intention‐to‐treat analyses. 296 patients completed 14‐day treatment
 period according to study protocol and were included in the perprotocol analysis.
Selective reporting (reporting bias) Low risk Prior to its initiation, the study was registered (ISRCTN19646069). The protocol summary published on the
 LANCET website (http://www.thelancet.com/protocol‐reviews/05PRT‐17), planned outcomes reported.