. 2007 Oct 17;2007(4):CD002310. doi: 10.1002/14651858.CD002310.pub4

J78.

Methods	Setting: multicentre study in UK   Design: parallel group   Length of intervention period: 12 weeks   Randomisation: yes, method unclear   Allocation concealment: unclear   Masking: open label   Excluded: not stated   Withdrawals: stated   Baseline characteristics: comparable   Jadad score: 2
Participants	197 adults. Mean age: 51‐52.   Inclusion criteria: >18 years; 600‐1000mcg/d; Two of following criteria:   i) am PEF <70% predicted in last 7 days of baseline; ii) >/=15% reversibility within 12 weeks prior to start of study; iii) diurnal variation >/=20% on at least 4/last 7 days; asthma score >/=1 on at least 4/last 7 days. Exclusion criteria: maintenance OCS/parental administration of CS; pregnant women, lactation or likely to become pregnant during course of study
Interventions	FP: 500mcg 2xdaily (1000mcg/d) BUD: 600mcg 2xdaily (1200mcg/d) Delivery device: MDI
Outcomes	Morning PEF; Evening PEF; Clinic PEF; Symptoms; FEV1 (L); FVC (L)   Withdrawal; Assessment of asthma control; QoL (unspecified scale); Adverse events
Notes	Unpublished data available from www.ctr.gsk.co.uk
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Low risk	See Appendix 2
Allocation concealment?	Low risk	See Appendix 2
Blinding?   All outcomes	Low risk	Identical inhaler devices