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Therapeutics
Salmeterol and fluticasone propionate did not reduce mortality in chronic obstructive pulmonary disease

http://dx.doi.org/10.1136/ebm.12.4.114

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    Calverley PM, Anderson JA, Celli B, et al. Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease. N Engl J Med 2007;356:775–89.
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 Q In patients with chronic obstructive pulmonary disease (COPD), do salmeterol (SA) and fluticasone propionate (FP) reduce mortality more than placebo?

    Clinical impact ratings GP/FP/Primary care ★★★★★★★ IM/Ambulatory care ★★★★★★★ Respirology ★★★★★★☆

    METHODS

    Embedded ImageDesign:

    randomised, 2x2 factorial design, placebo controlled trial (Towards a Revolution in COPD Health [TORCH] trial).

    Embedded ImageAllocation:

    unconcealed.*

    Embedded ImageBlinding:

    blinded (patients, healthcare providers, and outcome assessors).*

    Embedded ImageFollow up period:

    3 years.

    Embedded ImageSetting:

    444 centres in 42 countries.

    Embedded ImagePatients:

    6184 patients with COPD who were 40–80 years of age (about 76% men) and had a smoking history of ⩾10 packs/year, a pre-bronchodilator forced expiratory volume in 1 second (FEV1) <60% of the predicted value, an increase of FEV1 <10% after using albuterol 400 µg, and a ratio of pre-bronchodilator FEV1 to forced vital capacity ⩽0.7. Exclusion criteria included asthma; previous lung surgery or lung transplantation; requirement for long term (⩾12 h/d) oxygen therapy; alcohol, drug, or solvent abuse; hypersensitivity to …

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    Footnotes

    • ↵* See glossary.

    • For correspondence: Dr P M Calverley, University Hospital Aintree, Liverpool, UK. pmacal{at}liverpool.ac.uk

    • Source of funding: GlaxoSmithKline.