Safety and efficacy of bronchial thermoplasty in symptomatic, severe asthma

Ian D. Pavord, Gerard Cox, Neil C. Thomson, Adalberto S. Rubin, Paul A. Corris, Robert M. Niven, Kian F. Chung, Michel Laviolette, Mike Berry, Dominick Shaw, Nicola Sheldon, John Miller, Parameswaran Nair, Sarah Goodwin, Kathleen Currie, Rekha Chaudhuri, Steve Bicknell, Eric Livingston, Jane Lafferty, Paulo Guerreiro CardosoPatricia Ristori Dias Soares, Bernard Higgins, Therese Small, Barbara Foggo, Curig Prys-Picard, Gill Fletcher, Pallav Shah, Mun Lim, Sally Meah, Simon Martel, Louis Philippe Boulet, Lucie Morel, Luce Trépanier

    Research output: Contribution to journalArticlepeer-review

    Abstract

    Rationale: Bronchial thermoplasty (BT) is designed to reduce airway smooth muscle and improve asthma control. Objectives: This study was conducted to determine the safety and efficacy of this procedure in subjects with symptomatic, severe asthma. Methods: Adults who were symptomatic despite treatment with fluticasone or equivalent at more than 750 μg/day, a long-acting β2-agonist, and other medications, which could include 30 mg or less of oral prednisolone/day, were randomized to BT or to a control group. After treatment, subjects entered a 16-week steroid stable phase (Weeks 6-22), a 14-week steroid wean phase (Weeks 22-36), and a 16-week reduced steroid phase (Weeks 36-52). Measurements and Main Results: BT resulted in a transient worsening of asthma symptoms. Seven hospitalizations for respiratory symptoms occurred in 4 of 15 BT subjects during the treatment period. Five hospitalizations were within 3 days of treatment. Two subjects had segmental collapse involving the most recently treated lobe; one required bronchoscopy and aspiration of a mucus plug. There werenohospitalizations during this period in the17 control subjects. The rate of hospitalizations was similar in both groups in the post-treatment period. At 22 weeks, BT subjects had significant improvements versus control subjects in rescue medication use (-26.6 ± 40.1 vs. -1.5 ± 11.7 puffs/7 d, P <0.05), prebronchodilator FEV 1% predicted (14.9 ± 17.4 vs. -0.94 ± 22.3%, P = 0.04), and Asthma Control Questionnaire scores (-1.04 ± 1.03 vs. -0.13 ± 1.00, P = 0.02). Improvements in rescue medication use and Asthma Control Questionnaire scores remained significantly different from those of controls at 52 weeks. Conclusions: BT is associated with a short-term increase in asthma-related morbidity. However, there is preliminary evidence of long-lasting improvement in asthma control. Clinical trial registered with www.clinicaltrials.gov (NCT 00214539).
    Original languageEnglish
    Pages (from-to)1185-1191
    Number of pages6
    JournalAmerican Journal of Respiratory and Critical Care Medicine
    Volume176
    Issue number12
    DOIs
    Publication statusPublished - 15 Dec 2007

    Keywords

    • Airway smooth muscle
    • Asthma
    • Bronchial thermoplasty
    • Bronchoscopy
    • Radiofrequency energy

    Fingerprint

    Dive into the research topics of 'Safety and efficacy of bronchial thermoplasty in symptomatic, severe asthma'. Together they form a unique fingerprint.

    Cite this