Tsang 2004.
Methods | Randomised double‐blind, prospective placebo controlled trial with study duration of 52 weeks. There were no dropouts. |
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Participants | 60 participants (mean age 56.4 years, 38 females) with HRCT proven bronchiectasis. Fluticasone group: n = 30, age: mean 56.1 (SD 14). Placebo group: n = 30, age: mean 56.7 (SD 11.3). 16 were P aeruginosa colonised and 44 were not. Inclusion: absence of asthma or other unstable systemic disease; and "steady state" bronchiectasis (< 20% alteration of 24‐hour sputum volume, FEV1 and FVC) and absence of deterioration in respiratory symptoms at baseline visit. Exclusion: unreliable clinic attendance, known adverse reaction to fluticasone and asthma. |
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Interventions | Inhaled fluticasone 500 µg twice daily by accuhaler or placebo for 52 weeks. | |
Outcomes | The participants were followed up at ‐2, ‐1, 0, 4, 12, 24, 36, 48 and 52 weeks after commencement of therapy for measurement of FeNO. | |
Notes | Data not included in the final analysis since medians and inter‐quartile range reported in this study. The study was supported by a CRCG Grant of the University of Hong Kong. The Accuhalers were donated by GlaxoWellcome, China. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No information was provided within the published article about generation of randomisation. |
Allocation concealment (selection bias) | Unclear risk | No mention on allocation concealment. |
Blinding (performance bias and detection bias) All outcomes | Low risk | Quote: "performed a double blind, placebo controlled study". |
Incomplete outcome data (attrition bias) All outcomes | Low risk | There were no dropouts. |
Selective reporting (reporting bias) | Low risk | No suggestion that selective reporting may have been done. |
Other bias | High risk | Baseline value of the 2 groups were significantly different. |