Tsang 1998.
Methods | Randomised double‐blind, placebo controlled prospective trial with study duration of 4 weeks. There were no dropouts. |
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Participants | 24 participants (mean age 51 years, 12 females) with HRCT proven bronchiectasis. Fluticasone group: n = 12, 6 females, age: mean 43 (SD 11). Placebo group: n = 12, 8 females, age: mean 56.8 (SD 11). Inclusion: daily sputum > 10 mL, absence of asthma or other unstable systemic disease; and "steady state" bronchiectasis (< 10% alteration of 24‐hour sputum volume, FEV1 and FVC). Exclusion: unreliable clinic attendance, known adverse reaction to fluticasone, regular use of ICS and asthma. |
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Interventions | Inhaled fluticasone 500 µg twice daily by accuhaler or placebo for 4 weeks. | |
Outcomes |
Sputum leukocyte density, bacterial densities and concentrations of interleukin (IL)1B, IL 8, TNF alpha and leukotriene B4 were all measured at the time of randomisation and at 4 weeks. |
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Notes | Geometric mean was used instead of arithmetic mean. Hence, none of the lung function data were included in the final analysis. No mention of funding source. | |
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 of how allocation was done. |
Blinding (performance bias and detection bias) All outcomes | Low risk | Quote: "performed a double blind, placebo controlled study". Comment: Probably done. |
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 | The baseline values for lung functions, sputum amount and sputum inflammatory markers were significantly different, thus were subject to bias. |