SESSION TITLE: Childhood Asthma Posters
SESSION TYPE: Original Investigation Poster
PRESENTED ON: Wednesday, October 29, 2014 at 01:30 PM - 02:30 PM
PURPOSE: To evaluate the efficacy and safety of adding once-daily tiotropium Respimat® (TioR) 5µg or 2.5µg to ICS in adolescent pts with symptomatic asthma.
METHODS: 48-wk Phase III, randomized, double-blind, placebo-controlled, parallel-group trial (NCT01257230) in asthmatic adolescents (12-17 yrs). Inclusion criteria: ≥3-month asthma history; pre-bronchodilator FEV1 ≥60% and ≤90% predicted; screening ACQ ≥1.5; non-smokers. Pts were randomized to once-daily TioR 5μg, TioR 2.5μg, or placebo Respimat® (pboR) add-on to ICS (12-14 yrs 200-400µg; >14 yrs 400-800µg budesonide or equivalent). Primary efficacy endpoint at Wk 24: peak FEV1(0-3h). Safety endpoints included incidence and intensity of AEs, changes in vital signs, ECG and clinical laboratory findings.
RESULTS: 397 pts were treated over 48 wks with TioR 5μg (n=134), TioR 2.5μg (n=125), or pboR (n=138) add-on to maintenance ICS. Mean age 14.3 yrs; age 12-14 yrs 54.2%; mean duration of asthma 7.86 yrs; 65% male; mean FEV1 % predicted at baseline 82.8. Mean treatment exposure was evenly distributed: TioR 5μg 333.3 days; TioR 2.5μg 324.8 days; pboR 332.3 days. A 94.7% retention rate with adolescent pts was achieved. Patients on TioR 5 µg or TioR 2.5 µg doses achieved the primary endpoint FEV1(0-3h) at 24 wks and secondary endpoint FEV1(0-3h) at 48 wks. TioR 2.5µg also resulted in other lung function improvements. The percentage of patients with ≥1 AE was similar for all groups: TioR 5μg 62.7%; TioR 2.5μg 63.2%; pboR 59.4%. The most frequently reported AEs were asthma (17.2%; 21.6%; 23.2%), nasopharyngitis (14.9%; 10.4%; 12.3%), and viral respiratory tract infection (7.5%; 8.8%; 8.0%) for TioR 5μg, TioR 2.5μg, and pboR, respectively. Drug-related AEs were infrequent, ranging from 3.0% for TioR 5µg to 0.8% with TioR 2.5μg and 0.7% on pboR; all were mild or moderate in intensity. Incidence of AEs leading to discontinuation, severe AEs, and SAEs was low and comparable between treatment groups. No cardiac AEs or deaths were reported during the 1-year study. No significant changes in vital signs, ECG or clinical laboratory findings were observed across treatment groups.
CONCLUSIONS: Tiotropium Respimat® add-on to ICS significantly improves lung function, has a safety profile comparable with pboR, and is well tolerated in adolescent pts with symptomatic asthma.
CLINICAL IMPLICATIONS: Tiotropium Respimat® is an effective bronchodilator when added-on to ICS. The safety and tolerability of tiotropium Respimat® appear similar to pboR in adolescent pts with symptomatic asthma.
DISCLOSURE: Jonathan Bernstein: Grant monies (from industry related sources): Principal Investigator, Other: Editor Journal of Asthma Mandy Avis: Employee: Boehringer-Ingelheim John Downie: Employee: Boehringer-Ingelheim Michael Engel: Employee: Boehringer-Ingelheim Petra Moroni-Zentgraf: Employee: Boehringer-Ingelheim Anna Unseld: Employee: Boehringer-Ingelheim Mark Vandewalker: Grant monies (from industry related sources): Boehringer-Ingelheim The following authors have nothing to disclose: Attilio Boner, Eckard Hamelmann
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.