Regelmann 1990.
| Methods | Double‐blind placebo‐controlled RCT. Parallel study. Duration: 14 days. Single centre. Country: USA. |
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| Participants | 15 participants with CF and chronic P. aeruginosa infection who had experienced a deterioration in FEV1 greater than 10% over previous 1 ‐ 6 months. Intervention 1; 8 participants; mean (SD) age 21 (6.5) years; 6 males, 2 females. Intervention 2: 5 participants; mean (SD) age 22 (7.2) years; 3 males, 2 females. |
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| Interventions | Lead‐in period of 4 days consisting of chest physiotherapy and bronchodilators then those that did not deteriorate further were randomised to receive 1 of following. Intervention 1; IV tobramycin 3 mg 1x daily and IV ticarcillin 70 mg/kg with dose frequency adjusted to achieve target range. Intervention 2: IV placebo (dextrose water). |
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| Outcomes | Lung function (FEV1, FVC, FEF25‐75%), weight, adverse effects. | |
| Notes | An improvement in weight and lung function was observed in the lead‐in period before antibiotic therapy was commenced. It is uncertain whether this improvement reduced the measured change in the placebo group. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomised by table of random numbers. |
| Allocation concealment (selection bias) | Unclear risk | No detail. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Described as double blind. Little information given, sham dose adjustment of placebo was given a well as treatment groups. One investigator not involved in clinical care was unblinded and responsible for dosing and allocation. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Described as double blind but little detail provided. |
| Incomplete outcome data (attrition bias) All outcomes | High risk | 1 participant withdrew from the placebo arm on day 3 and did not contribute data. 4 participants contribute lung function data for the placebo group compared to 8 participants in the antibiotic group. |
| Selective reporting (reporting bias) | Unclear risk | Insufficient information. |
| Other bias | High risk | UoA issues ‐ 1 participant re‐entered the study after a 2‐year gap. |