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

Elborn 1992.

Methods A prospective, double‐blind, placebo controlled, randomised cross‐over design with study duration of 6 weeks.
There were five participants who dropped out; we are unsure when these occurred. Two participants declined to take part in second limb of study.
No washout period mentioned.
Participants Twenty participants (12 females, mean age 50 years, range 30 to 65) were studied with bronchiectasis diagnosed by bronchogram in 18 and computed tomography scan in two. No participant received a course of antibiotics for at least 8 weeks prior to the study.
Exclusion: participants with hypogammaglobulinaemia, cystic fibrosis, ABPA or primary ciliary dyskinesia, as well as those taking OCS or ICS.
Interventions Inhaled beclomethasone dipropionate 750 µg twice daily by MDI or placebo for 6 weeks.
Outcomes
  • FEV1

  • FVC

  • PEFR (morning and evening)

  • 24‐hour sputum amount collected weekly from patients

  • visual analogue scale for cough, wheeze and dyspnoea recorded on a diary card and on a 75 mm line (higher value better)

Notes Cross‐over design with no washout period. Separate results of first arm not available. Data not included in analysis. No funding source mentioned, though acknowledgement for ICS was given to Allen and Hanburys.
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 information about concealment was reported in the article.
Blinding (performance bias and detection bias) 
 All outcomes Low risk Quote: "double‐blinded" and "matched placebo".
Incomplete outcome data (attrition bias) 
 All outcomes High risk There were 5 patients who dropped out; we are unsure when these occurred. Two patients declined to take part in second arm of study.
Selective reporting (reporting bias) Low risk No suggestion that selective reporting may have been done.
Other bias High risk Cross‐over design with no washout period. Separate results of first arm not available.