| Methods |
Setting: single centre study
Design: crossover study
Length of intervention period: 2 x 6 week treatment arms
Randomisation: Not described.
Allocation concealment: Not described
Masking: double blind
Excluded: Not stated
Withdrawals: Stated (non‐ITT)
Jadad score: 3 |
| Participants |
N=20. (M/F: 8/12); Mean age: 38 (SEM 4); Mean ICS usage: 485mcg (78) for 13 participants, remaining 5 used SABA prn; FEV1 % predicted: 88.5 (SEM 2.5); am PEF (L/min): 443 (SEM 19); OUCC (nmol/mmol): 6.59 (SEM 0.7); Methacholine PD20 (mcg): 96.6 (SEM 22.1)
Inclusion criteria: FEV1 >70% predicted, PD20 <500mcg; SABA only or constant ICS dose up to 1200mcg
Exclusion criteria: history URTI; prior OCS usage |
| Interventions |
FP500 versus BDP500. Inhaler device: pMDI. |
| Outcomes |
FEV1 (% predicted); am PEF (L/min); OUCC (nmol/mmol); exhaled tidal NO (ppb); methacholine PD20; overnight urinary cortisol/creatinine |
| 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 |
Low risk |
Identical inhaler devices |
