Fitzgerald 2005.
| Methods | Randomised, blinded, cross‐over placebo‐controlled trial with 2‐week interventions and 2‐weeks washout. Measurements were taken at 0, 2, 4 and 6 weeks. Generation of allocation schedule and concealment of treatment allocation were clear. ITT analysis was used. | |
| Participants | 52 stable children randomised; mean (SD) age 10.7 (3.2) years; mean (SD) FEV1 83 (18) % predicted. There were 2 withdrawals due to protocol violations (1 nebulisation instead of 2) in the second arm while inhaling dornase alfa after airway clearance. | |
| Interventions | Delivery 30 minutes before airway clearance techniques compared to delivery 30 minutes after airway clearance. ACT = 'physiotherapy' or PEP mask. DNase naive. | |
| Outcomes | FEV1, FVC, QOL (composite QWB). VO2max (Shuttle), FEF25‐75, adherence (vials returned), adverse events (34 in 26 participants including diverse symptoms ‐ intervention group unclear). |
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| Notes | Subgroup analysis FEV1 for those with Pseudomonas aeruginosa in the preceding 2 years (n = 17) PEDro 9/10 (Eligibility criteria: yes; random allocation: yes; concealed allocation: yes; baseline comparability: no; blind participants: yes; Blind therapists: yes; blind assessors: yes; adequate follow‐up: yes; ITT analysis: yes; between‐group comparisons: yes; point estimates and variability: yes). |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Block randomisation by an independent investigator was used. |
| Allocation concealment (selection bias) | Low risk | Independent distant pharmacy. |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Placebo used; participants, therapists and assessors blinded. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 2 participants did not take both medications in the second arm. |
| Selective reporting (reporting bias) | Low risk | QOL, VO2max, FEF25‐75 and adverse events and were reported as non‐significant in the publication but data were not provided by authors. |