Burge 2000 [ISOLDE].
Methods |
Design: Double blind, placebo controlled study Duration: 3 years Location: Conducted at 18 hospitals in the UK |
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Participants |
Population: 751 people were randomised to fluticasone (376) and placebo (375) Baseline characteristics: Age (mean years): flut 63.7, placebo 63.8 Male %: flut 75.0, placebo 74.1 % FEV1 predicted: flut 50.3, placebo 50.0 Pack‐years (mean): flut 44, pbo 44 Inclusion criteria: Current or former smokers aged 4075 years with nonasthmatic chronic obstructive pulmonary disease. Baseline FEV1 after bronchodilator was at least 0.8 litres but less than 85% of predicted normal, and the ratio of FEV1 to forced vital capacity was less than 70%. Previous use of inhaled and oral corticosteroids was permitted. Exclusion criteria: Patients were excluded if their FEV1 response to 400 µg salbutamol exceeded 10% of predicted normal, they had a life expectancy of less than five years from concurrent diseases, or they used beta blockers. |
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Interventions | 1. Fluticasone 500 bid (ICS) 2. Placebo (PBO) Inhaler device: Metered dose inhaler with a spacer device Allowed co‐medications: Nasal and ophthalmic corticosteroids, theophyllines, and all other bronchodilators were allowed during the study |
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Outcomes | Decline (ml/year) in FEV1 after bronchodilator, frequency of exacerbations, changes in health status, withdrawals because of respiratory disease, morning serum cortisol concentrations, and adverse events | |
Notes |
Funding: GlaxoWellcome Research and Development Identifier(s): unknown |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer generated allocation (block size of six) |
Allocation concealment (selection bias) | Low risk | Patients were randomised sequentially from a list comprising treatment numbers only |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Three year double blind phase using an identical placebo inhaler |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not described |
Incomplete outcome data (attrition bias) All outcomes | High risk | Very high dropout in both groups (43% and 53%) |
Selective reporting (reporting bias) | Unclear risk | No outcomes appear to be missing but couldn't locate protocol to ensure all were reported. Author attempted contact with GSK statistician but no data were provided in time for publication. |