Verhoeven 2002.
Methods | Design: Randomised, double‐blind, placebo‐controlled study Duration: 6 months (+ 2 week run‐in) Location: single centre in the Netherlands | |
Participants |
Population: 23 participants were randomised to fluticasone (10) and placebo (13) Baseline characteristics Age (mean years): flut 54, pbo 56 % Male: flut 80, pbo 84.6 % FEV1 predicted: flut 66, pbo 61 Pack‐years (mean): flut 25, pbo 26 Inclusion criteria: Chronic productive cough, FEV1 <70% of predicted normal value, FEV1 reversibility of <10% predicted after 750 mg terbutaline administered by metered dose inhalation, negative serological examination (Phadiatop test), and negative skin prick tests for standard inhaled allergens).22 Patients with an FEV1/inspiratory vital capacity (IVC) ratio of <0.70 were also included, provided their total lung capacity (TLC) was greater than the predicted value + 1.64SD. Reference values were obtained from ECGS standards.23 Participants had to be current and persistent smokers aged 40–70 years. Exclusion criteria: History of asthma characterised by attacks of dyspnoea, chest tightness or wheezing, respiratory tract infection in the 4 weeks preceding the first visit, or were suffering from serious or unstable concomitant disease |
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Interventions | 1. Fluticasone 500 BID (ICS) 2. Placebo (PBO) Inhaler device: Diskhaler Allowed co‐medications: Eligible patients using anti‐inflammatory treatment including non‐steroidal anti‐inflammatory drugs were asked to refrain from oral prescriptions for at least 3 months and from inhaled corticosteroids, sodium cromoglycate, or nedocromil sodium for at least 6 weeks before the start of the study. Long acting b2 agonists, xanthine derivatives, and antihistamine drugs also had to be stopped at least 6 weeks before the start of the study. |
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Outcomes | Use of secondary medication, compliance, FEV1, PC20, FEV1/FVC, cortisol levels and inflammatory markers | |
Notes | Funding: GlaxoWellcome Identifier(s): FLIL44/FMS40060 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomly allocated [no details, but industry funded] |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Described as double‐blind [presumed participants and personnel/investigators] |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not described |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No dropouts in either group |
Selective reporting (reporting bias) | Low risk | Adverse event data not adequately reported but information supplied by the author. |