| Methods |
A prospective, double‐blind, parallel group placebo controlled trial. |
| Participants |
77 participants included over a 3‐year period. Age range 40 to 85 years, mean age 68.06 years. Seven did not complete the study: three died from respiratory failure and four pulled out voluntarily. 37 analysed in the budesonide group and 33 in the placebo group. Mean age of the budesonide group was 68 years and that of the placebo group was 66 years. 19 (27.1%) participants in the budesonide group and 18 (25.7%) in the placebo group had Pseudomonas aeruginosa (P aeruginosa) cultured from their sputum. The mean (SD) baseline FEV1% predicted in the budesonide and the placebo group was 64.6% (25.1) and 64.7% (27), respectively. |
| Interventions |
400 µg inhaled budesonide twice a day versus placebo for 6 months. |
| Outcomes |
Total symptom score which included I) cough and sputum production; and ii) dyspnoea.
Proportion with exacerbations Hospital admission FEV1 difference FVC difference SGRQ Sputum IL‐8 & cellularity Microbiological changes including percentage P aeruginosa positive at the end of 6 months
|
| Notes |
Additional information provided by the authors. The study was supported by the Catalan Foundation of Pneumology grant. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Hospital pharmacy (third party) performed randomisation and dispensed inhalers. |
| Allocation concealment (selection bias) |
Unclear risk |
No mention how allocation was done. |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Quote "parallel, placebo‐masked clinical trial". Probably done. |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
7 dropouts, 6 of whom were from the placebo group. Data of dropouts not included. Since 3 of these died of respiratory failure, all belonging to the placebo group, potential for bias on outcome if data not included. |
| Selective reporting (reporting bias) |
Low risk |
No suggestion that selective reporting may have been done. |
| Other bias |
Low risk |
No other risk of bias identified |
