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. 2016 May 13;2016(5):CD011801. doi: 10.1002/14651858.CD011801.pub2

Lederle 1987.

Methods Design: randomised, double‐blind trial
Duration: corticosteroid treatment continued for 7 weeks post discharge; follow‐up continued until 12 weeks after initial admission
Setting: treatment initiated while inpatient and completed at home
Participants Population: 43 adults with an acute exacerbation of asthma were randomised to a long taper course (n = 22) or a short taper course (n = 21) of prednisolone
Age: 30‐78 years; mean age in long taper group 62.6 years and in short taper group 63 years
Inclusion criteria: men admitted to medicine services with exacerbation of asthma requiring systemic steroids; exacerbation defined as worsening dyspnoea due to airways obstruction with no other cause identified, and evidence of a reversible component to obstruction
Exclusion criteria: already receiving oral corticosteroids; evidence of pneumonia, pulmonary oedema or cardiomegaly on chest x‐ray; other significant lung disease such as bronchiectasis, fibrosis, cancer; renal failure, hepatic failure and inability to comply with study protocol
Percentage withdrawn: withdrawal 0% in both treatment arms
Allowed medication: beta‐agonists and theophylline allowed at treating physician's discretion. Inhaled beclomethasone given throughout study period
Disallowed medication: antibiotics not allowed once tapering period had begun
Interventions Prednisolone long taper group: 45 mg prednisolone once daily reducing by 5 mg weekly to 0 mg daily over 7 weeks (total dose 1575 mg prednisolone equivalent)
Prednisolone short taper group: 45 mg prednisolone once daily reducing by 5 mg daily to 0 mg daily over 7 days (total dose 225 mg prednisolone equivalent)
Outcomes Failure of tapering regimen (defined as re‐exacerbation of asthma requiring further corticosteroid administration during 12‐week follow‐up period); symptom diary with 10‐point VAS to evaluate breathing each day from 'best' to 'worst'; physical examination, spirometry, symptoms, adverse events and compliance assessed at 4, 8 and 12 weeks post admission
Notes Type of publication: peer‐reviewed
Funding: placebo tablets provided by Rowell Laboratories Inc., Baudette, Minn
Other: mean age in both groups over 60, all but 5 included participants with > 10 pack‐year smoking history, mean of 49 years of age in long‐taper group and 56 in short‐taper group. Baseline spirometry results also suggest that many participants may have had a diagnosis of COPD (mean FEV1/FVC in both groups < 0.7). Study authors acknowledge that many participants may have had COPD with a reversible component
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "Patients were randomly assigned.."; no further details
Allocation concealment (selection bias) Unclear risk No details
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk All participants received identical calender blister packs that contained the tapering regimen
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Primary outcome of failure of tapering regimen (i.e. re‐exacerbation requiring additional oral steroids) decision made by physician blinded to participant allocation, as was decision to admit.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All 43 enrolled and randomised participants followed up to 12 weeks as planned (2 withdrew before starting taper; results not included)
Selective reporting (reporting bias) High risk Not all outcomes reported in a way allowing for meta‐analysis. FEV1 outcome reported as percentage of baseline value without variance. Diary measures narratively reported in text with minimal supporting data
Other bias Low risk None noted