Skip to main content
. 2007 Oct 17;2007(4):CD002310. doi: 10.1002/14651858.CD002310.pub4

Connolly 1995.

Methods Setting: multicentre study UK, primary care 
 Design: parallel group 
 Length of intervention period: 8 weeks 
 Randomisation: yes, method not stated 
 Allocation concealment: unclear 
 Masking: open, no blinding 
 Excluded: stated 
 Withdrawals: stated 
 Baseline characteristics: comparable 
 Jadad score: 2
Participants 283 adults enrolled, 190 randomised: 43M 39F 
 Age range: 18‐70 years 
 Inclusion criteria: 
 Adult asthmatic patients 
 Receiving BDP or BUD 200 mcg/d or less 
 During 2 week run‐in period: 
 Symptom score 1 or greater on 10 successive days 
 FEV1 > 50 (% predicted) 
 Able to use delivery devices 
 Exclusion criteria: 
 Current treatment with OCS or > 6 courses in last year 
 Change in asthma therapy in last 6 weeks 
 Serious coexistent illness
Interventions FP: 100 mcg 1 actuation 2xdaily (200 mcg/d) via Diskhaler DPI
BUD: 200 mcg 1 actuation 2xdaily (400 mcg/d)via Tubuhaler DPI
Outcomes Change in morning PEFR compared to baseline 
 Change in diurnal variation in PEFR compared to baseline 
 % symptom free days 
 % symptom free nights 
 % rescue beta2 agonist free days 
 % rescue beta2 agonist free nights 
 Physician assessed level of overall asthma control 
 Patient assessed level of overall asthma control 
 Morning plasma cortisol
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Adequate sequence generation? Unclear risk Described as randomised; other information not available
Allocation concealment? Unclear risk Information not available
Blinding? 
 All outcomes High risk Open label