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 |
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| 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 |