Kardos 2007.
Methods | Design: Randomized, double‐blind, parallel‐group study Duration: 10 months (+ 4 week run‐in) Location: 95 respiratory centres in Germany | |
Participants |
Population: 994 participants were randomised to salmeterol (487) and salmeterol/fluticasone combination (507) Baseline characteristics Age (mean years): salm 64.0, salm/flut 63.8 % Male: salm 77.6, salm/flut 74.0 % FEV1 predicted: salm 40.3, salm/flut 40.4 Pack‐years (mean): salm 37.0, salm/flut 36.8 Inclusion criteria: Outpatients with post‐bronchodilator FEV1 < 50% predicted., FEV1/FVC of 70% predicted or less, age of 40 yr or more, smoking history of 10 pack‐years or more, and a documented history of two or more moderate to severe exacerbations in the last year before the study. Exclusion criteria: Patients with COPD exacerbations, hospital admissions, or change in COPD therapy during the 4 wk before Visit 1 or during the 4‐wk run‐in period were excluded. Patients with asthma, significant lung diseases other than COPD, and need for long‐term oxygen therapy or chronic systemic steroid use were also excluded |
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Interventions | 1. Salmeterol 50 bid (LABA) 2. Salmeterol/fluticasone 50/500 bid (LABA/ICS) Inhaler device: Diskus dry powder Allowed co‐medications: Inhaled salbutamol was used as reliever medication, and regular treatment with short‐acting bronchodilators, antioxidants/mucolytics, short‐acting oral beta2 agonists, and theophylline was permitted |
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Outcomes | Number of exacerbations, pre‐bronchodilator PEF, post‐bronchodilator FEV1, SGRQ, symptoms and breathlessness, diary card data | |
Notes | Funding: GlaxoSmithKline Identifier(s): unknown | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Consecutive numbers were assigned to patients that determined the blinded treatment based on a centrally generated list with blocks of six |
Allocation concealment (selection bias) | Low risk | Randomisation list was centrally generated |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Described as double‐blind treatment [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 | Similar withdrawal rates in each group. ITT included 99.6% of the randomised population (4 patients were excluded due to a randomisation error) |
Selective reporting (reporting bias) | Unclear risk | Unable to locate prospective trial registration to check that all outcomes were reported. Author contacted who forwarded request to GSK ‐ no data were provided in time for publication. |