Methods | Parallel group design. Randomisation: computer generated. Numbers were generated off-site. Once a treatment number had been assigned to a participant it could not be assigned to any other participant. Blinding: Double blind. Participants received identically packaged and presented placebos. Withdrawals: Described. Trial duration: 2 week run-in period, 52 weeks treatment, 2-week follow-up Intention to treat analysis: stated Jadad Score: 5 |
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Participants |
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Interventions | Run-in: 2 weeks. All maintenance treatment with ICS and LABA ceased. 1) FPS 50 mcg/500 mcg bid. 2) Placebo Additional treatment groups not covered in this review: 3) SAL 50 mcg bid. 4) FP 500 mcg bid. Inhaler device: DPI | |
Outcomes | FEV1; PEF; exercise tolerance; quality of life: SGRQ; dyspnoea and symptoms (symptom score for shortness of breath, cough and sputum production); exacerbations (defined as requirement for antibiotics, oral steroids or both); rescue salbutamol use | |
Notes | FEV1 reversibility (% predicted normal) Mean Reversibility (% predicted) = 3.8 | |
Risk of bias | ||
Item | Authors’ judgement | Description |
Adequate sequence generation? | Yes | As described above |
Allocation concealment? | Yes | As described above |
Blinding? All outcomes |
Yes | Idenitical inhaler devices |