DiMango 2014.
Methods | Randomised, double‐blind, placebo‐controlled trial over 24 weeks; participants were evaluated every 8 weeks. | |
Participants | 21 people screened, 2 withdrew consent prior to randomisation, 2 were ineligible. 17 people (9 to active treatment, 8 to placebo) with CF, age >18, of which 15 completed the trial. | |
Interventions | 2 groups: 1. esomeprazole 40 mg 2x daily; 2. placebo. |
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Outcomes | Primary outcome measure: time to first exacerbation (defined as initiation of treatment with IV or oral antibiotics for at least 7 days based on respiratory symptoms). Secondary outcome measures included: assessment of CF related quality of life (CFQ‐R); GSAS; exacerbation rate; and lung function. |
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Notes | 2 week run‐in period prior to randomisation, during which all participants underwent 24‐hour amublatory pH probe monitoring. Participants and investigators blinded to the results. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Described as randomised, but no details of method given. Used a 1:1 ratio of treatment to placebo regardless of pH probe results, stratified by study centre and FEV1 decile. |
Allocation concealment (selection bias) | Unclear risk | Colombia University Research Pharmacy prepared study medications. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not discussed. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 1 loss to follow‐up in esomeprazole arm (moved), 1 discontinued in placebo arm because of lung transplantation. For participants withdrawn after randomisation, longitudinal analyses compared each value at the start of the treatment period to the last observed value carried forward for each variable. |