Robinson 1999.
Methods | Randomised controlled trial. Design: 4‐way cross‐over trial (no information on any washout period). Duration: single day for each intervention. Participants were initially randomised to receive either the mannitol or HS. On the second day they were randomised to either the remaining active or the control for the first day. On the third day they were randomised to receive either the remaining active or either of the controls. The final day was the remaining control. Location: Australia. |
|
Participants | Total participants: n = 12, 5 males and 7 females.
Age mean (SD) (range): 29.9 (9.4) (16 ‐ 46) years. BMI mean (SD) (range): 21.0.(1.8) (18 ‐ 24). 10/12 participants were colonised with Pseudomonas aeruginosa, 7/12 had Stapylocococcus aureus (including the 2 participants without Pseudomonas aeruginosa) and 4/12 had Aspergillus fumigatus. |
|
Interventions | Pre‐treated with terbutaline 1000 mcg (turbulhaler). Group 1: single dose 7 mL HS 6%. Group 2: IS (0.9%) plus matched voluntary cough. Group 3: mannitol 300 mg (encapsulated dry powder). Group 4: empty capsules with matched voluntary coughs. | |
Outcomes | Sputum isotope % clearance at 30 minutes, sputum isotope clearance at 90 minutes, mucociliary clearance. | |
Notes | Isotope clearance was reported in this paper as occurring at 60 minutes. This is actually the same time period as the 90‐minute clearance reported in 1997 paper. The terminology had been changed. Lung function data are the mean values for all trial days: FEV1 % predicted mean (SD) (range): 60.2.(16.5) (42 ‐ 87). FVC % predicted mean (SD) (range): 78.8.(16.5) (47 ‐ 102). FEF25‐75 % predicted mean (SD) (range): 32.5.(21.1) (11 ‐ 77). No sample size calculation stated. |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No detail provided. |
Allocation concealment (selection bias) | Unclear risk | The allocation concealment process was not described. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants could discern taste. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | The trials were coded such that the investigators were blinded to the identity of the intervention at the time of data analysis. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No discussion of whether an ITT analysis had been used or of any withdrawals. |
Selective reporting (reporting bias) | Low risk | All outcomes stated in the methods were described in the results. |
Other bias | Unclear risk | Washout period not clear. No sample size calculation stated. The time course of the effect of the interventions on the outcomes is not clear. |