Tsang 2005.
| Methods | Randomised double‐blind, prospective placebo controlled trial with study duration of 52 weeks. 5 dropouts in the placebo arm (1 at 4 weeks, 3 at 24 weeks and 1 at 52 weeks) and 8 dropouts in the fluticasone arm (2 at 4 weeks and 1 each at 6, 22, 32, 36, 50 and 52 weeks). |
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| Participants | 89 patients recruited. Three participants withdrew. 86 participants (57 females, mean age 58.5 years) with HRCT proven bronchiectasis randomised between fluticasone and placebo. Fluticasone group: n = 43, 23 females, age: mean 57.7 (SD 14.4). Placebo group: n = 43, 34 females, age: mean 59.2 (SD 14.2). 23 were P aeruginosa colonised. Inclusion: absence of asthma or other unstable systemic disease; and "steady state" bronchiectasis (< 20% alteration of 24‐hour sputum volume, FEV1 and FVC) and absence of deterioration in respiratory symptoms at baseline visit. Exclusion: unreliable clinic attendance, known adverse reaction to fluticasone or quinolones and regular usage of ICS. |
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| Interventions | Inhaled fluticasone 500 µg twice daily by accuhaler device or matched placebo for 52 weeks. | |
| Outcomes | The participants were followed up at ‐2, ‐1, 0, 4, 12, 24, 36, 48 and 52 weeks after commencement of therapy. Primary outcomes
Secondary outcomes
Improvement or deterioration was defined as > 20% change from baseline. |
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| Notes | SD calculated from P value for sputum volume and exacerbation frequency and from confidence interval for the rest. The study was partially funded by GlaxoWelcome (Hong Kong). | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "randomisation (block of 4)", however, no information about who generated the randomisation codes. |
| Allocation concealment (selection bias) | Unclear risk | No information about concealment was reported in the published article. |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Quote: "double blind, placebo controlled study". |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Data of dropouts not compared to those included in analysis. |
| Selective reporting (reporting bias) | Low risk | No suggestion that selective reporting may have been done. |
| Other bias | High risk | Significant differences at the baseline on clinical features of "cough" and "dyspnoea" between the two groups to allow for post‐treatment comparison. |
ABPA: allergic bronchopulmonary aspergillosis DLCO: diffusing capacity of the lungs for carbon monoxide FeNO: fractional exhaled nitric oxide FEV1: forced expiratory volume (in 1 second) FVC: forced vital capacity HRCT: high resolution computed tomography HRQoL: health‐related quality of life ICS: inhaled corticosteroids MDI: metered dose inhaler OCS: oral corticosteroids PEFR: peak expiratory flow rate RV: residual volume SD: standard deviation SGRQ: St George's Respiratory Questionnaire TLC: total lung capacity TNF: tumour necrosis factor