| Methods |
Setting: multicentre (N America)
Design: parallel group
Length of intervention period: 6 weeks
Randomisation: randomisation occurred at each centre
Allocation concealment: unclear
Masking: open label
Excluded: not stated
Withdrawals: Stated
Jadad score: 2 |
| Participants |
30 adults randomised (FP: 15; BDP: 15). FEV1 (L): FP: 3.04 (0.75); BDP: 3.01 (0.63); FEV1 % predicted: FP: 75.07 (SD 11.16); BDP: 73.33 (11.08); median weekly average symptom scores: FP: 0.26 ; BDP: 0.35; median weekly average of rescue medication: FP: 1.83; BDP: 1.63
Inclusion criteria: 18‐55 years; FEV1 55‐85%; >/=12% reversibility post SABA; improvement >/=200mL in FEV1, methacholine PC20 </=8 mg/mL; fall in FEV1 post exercise of >/=12%; am plasma value >/=5mcg/dL; smoking history of <10 pack years
Exclusion criteria: Smoking in previous year; topical/inhaled steroid treatment for any condition in previous 6 months, systemic steroids in previous 12 months |
| Interventions |
Serially increased doses of CFC FP or CFC BDP. Doses of FP/BDP taken at initial 6 weeks (FP: 44mcg BID ‐ 88mcg/d; BDP: 84mcg BID ‐ 168mcg/d). Inhaler device: MDI. |
| Outcomes |
Cortisol; FEV1 (L); methacholine PC 20; exhaled nitric oxide; exercise max absolute fall in FEV1; exercise fall in AUC; sputum eosinophils + 0.2 (%), neutrophils (%), eosinophilic cationic protein; symptoms; rescue medication usage |
| Notes |
Efficacy data only taken for first 6 weeks. Trialists responded with information on allocation concealment & blinding. |
| 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 |
Randomisation occurred at each centre |
| Blinding?
All outcomes |
High risk |
Open label |
