Busse 1998.

Methods	Setting: multicentre study USA, hospital outpatient clinic Randomisation: yes, method not stated Allocation concealment: unclear Design: parallel Intervention period: 12 weeks Masking: double‐blind Excluded: not stated Withdrawals: stated Baseline characteristics: comparable Jadad score=3
Participants	Subjects: 473 adults: 217M 256F Age range: 18 ‐ 70 years Inclusion criteria: Diagnosis of asthma (ATS criteria) for at least 6 months 15% reversibility of FEV1 with inhaled beta2 agonist or greater Use of inhaled or inhaled and oral corticosteroids for at least 6 months Use of BDP 300 ‐1000 mcg/d for one month prior to study Exclusion criteria: History of carcinoma or other significant disease Use of injectable corticosteroids Irregular use of oral corticosteroids
Interventions	BUD: 1. 200 mcg/d 2. 400 mcg/d 3. 800 mcg/d 4. 1600 mcg/d All treatments given twice daily in divided doses Placebo: twice daily lactulose Delivery device: Turbuhaler DPI
Outcomes	Change in FEV1 compared to baseline Change FVC compared to baseline Change FEF25‐50 compared to baseline Change morning PEFR compared to baseline Change evening PEFR compared to baseline Change daytime asthma symptom compared to baseline Change nighttime asthma symptom compared to baseline daily beta2 agonist use Early morning plasma cortisol Early morning plasma cortisol post ACTH
Notes	No reply from author to clarify details concerning randomisation method or provide standard deviation values for clinic spirometry, diary card PEFR, symptom scores or plasma cortisol levels.
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear