SESSION TITLE: Childhood Asthma Posters
SESSION TYPE: Original Investigation Poster
PRESENTED ON: Wednesday, October 29, 2014 at 01:30 PM - 02:30 PM
PURPOSE: A considerable proportion of adolescent patients (pts) with asthma remain symptomatic despite treatment with currently available therapies. The once-daily long-acting anticholinergic bronchodilator tiotropium Respimat® (tioR) add-on to ICS ± LABA improves lung function in adults with symptomatic asthma. Here we investigate the efficacy, safety, and 24-hour (24-h) bronchodilation of tioR add-on to medium-dose ICS in adolescent pts with symptomatic asthma.
METHODS: This randomized, double-blind, placebo-controlled, incomplete crossover study with 3 × 4-week treatment periods evaluated once-daily tioR 5 µg, 2.5 µg, and 1.25 µg add-on to medium-dose ICS vs placebo Respimat® (pboR) (NCT01122680) in adolescent pts with symptomatic asthma. Main inclusion criteria: aged 12-17 years; symptomatic at screening (seven-question Asthma Control Questionnaire mean score≥1.5); pre-bronchodilator forced expiratory volume in 1 second (FEV1) >60% and ≤90% of predicted. Exclusion criteria: significant respiratory disease other than asthma; exacerbation or acute respiratory infection during the previous 4 weeks. The primary endpoint was peak FEV1(0-3h) response (difference from baseline) at the end of each treatment period. Secondary endpoints included trough FEV1 response, FEV1 area under the curve (AUC) and forced vital capacity (FVC). AUC(0-24h/0-14h/14-24h) responses were also analyzed in a subset of pts (exploratory analysis).
RESULTS: 105 pts were randomized: median age 14 years; 63.8% male. TioR 5 µg provided statistically significant improvement in peak FEV1(0-3h) and trough FEV1 responses vs pboR (adjusted mean of difference ± standard error: 113 ± 39 mL; P=0.0043, and 151 ± 36 mL; P<0.0001, respectively). 49 pts underwent 24-h lung function testing. All doses of tioR improved 24-h bronchodilation compared with pboR when assessed with FEV1 AUC and FVC AUC(0-24h/0-14h/14-24h) responses. The small number of pts in the 24-h lung function subset did not permit rigorous statistical analysis. Adverse events were balanced across treatments groups; no dose-dependency was observed.
CONCLUSIONS: Once-daily tioR 5 µg add-on to medium-dose ICS provides sustained bronchodilation, is well tolerated, and has a safety profile comparable to placebo Respimat® in adolescent pts with symptomatic asthma.
CLINICAL IMPLICATIONS: Once-daily tiotropium Respimat® add-on to medium-dose ICS may provide a potential treatment option for adolescent pts with symptomatic asthma. Funding: Boehringer Ingelheim. Editorial assistance: Complete HealthVizion.
DISCLOSURE: Christian Vogelberg: Grant monies (from industry related sources): Funding in the context as participating study center, Boehringer Ingelheim Michael Engel: Employee: Boehringer-Ingelheim Petra Moroni-Zentgraf: Employee: Boehringer-Ingelheim Ralf Sigmund: Employee: Boehringer-Ingelheim John Downie: Employee: Boehringer-Ingelheim Mark Vandewalker: Grant monies (from industry related sources): Boehringer-Ingelheim The following authors have nothing to disclose: Migle Leonaviciute-Klimantaviciene, Viktorija Vevere, Ieva Cirule
This abstract includes data from a clinical trial of tiotropium in asthma. However, tiotropium is not approved for use in asthma and its safety and efficacy have not yet been established in asthma.