A proof of concept study to evaluate stepping down the dose of fluticasone in combination with salmeterol and tiotropium in severe persistent asthma

Tom Fardon, Kay Haggart, Daniel K. C. Lee, Brian J. Lipworth

    Research output: Contribution to journalArticle

    70 Citations (Scopus)

    Abstract

    We conducted a double blind, randomised, placebo-controlled, crossover study evaluating the effects of halving inhaled steroid dosage plus salmeterol, or salmeterol and tiotropium. Eighteen life-long non-smoking severe asthmatics [mean FEV1 1.49 l (51%)] were run-in for 4 weeks on HFA-fluticasone propionate 1000 µg daily, and were subsequently randomised to 4 weeks of either (a) HFA-fluticasone propionate 500 µg BD/salmeterol 100 µg BD/HFA-tiotropium bromide18 µg od; or (b) fluticasone propionate 500 µg BD/salmeterol 100 µg BD matched placebo. Measurements of spirometry and body plethysmography were made. Adding salmeterol to half the dose of fluticasone led to a mean improvement (95% CI) vs. baseline in morning PEF of 41.5 (14.0–69.0) l/min [p<0.05]; and RAW of 0.98 (0.14–1.8) cm H2O/l/s [p<0.05]. Adding salmeterol/tiotropium produced similar improvements in PEF and RAW, but also improved FEV1 by 0.17 (0.01–0.32) l [p<0.05]; FVC 0.24 (0.05–0.43) l [p<0.05] and reduced exhaled NO by 2.86 (0.12–5.6) ppb [p<0.05]. RV and TLC were not altered by either treatment; there were no significant changes in symptoms or quality of life compared with baseline. Addition of salmeterol/tiotropium to half the dose of fluticasone afforded small, but significant improvements in pulmonary function. These effects were not associated with commensurate changes in subjective symptoms or quality of life.
    Original languageEnglish
    Pages (from-to)1218-1228
    Number of pages11
    JournalRespiratory Medicine
    Volume101
    Issue number6
    DOIs
    Publication statusPublished - Jun 2007

    Keywords

    • Adult
    • Aged
    • Albuterol
    • Androstadienes
    • Asthma
    • Breath Tests
    • Bronchodilator Agents
    • Cross-Over Studies
    • Dose-Response Relationship, Drug
    • Double-Blind Method
    • Drug Administration Schedule
    • Drug Therapy, Combination
    • Female
    • Forced Expiratory Volume
    • Glucocorticoids
    • Humans
    • Male
    • Middle Aged
    • Nitric Oxide
    • Plethysmography, Whole Body
    • Quality of Life
    • Scopolamine Derivatives
    • Treatment Outcome
    • Vital Capacity

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