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. 2018 May 16;2018(5):CD000996. doi: 10.1002/14651858.CD000996.pub3

Tsang 1998.

Methods Randomised double‐blind, placebo controlled prospective trial with study duration of 4 weeks.
There were no dropouts.
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.
Interventions Inhaled fluticasone 500 µg twice daily by accuhaler or placebo for 4 weeks.
Outcomes
  • FEV1

  • FVC

  • TLC

  • RV

  • Diffusion capacity

  • PEFR

  • 24‐hour sputum volume (mean of 3 days)


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.
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.