SESSION TITLE: COPD Posters IV
SESSION TYPE: Original Investigation Poster
PRESENTED ON: Wednesday, October 28, 2015 at 01:30 PM - 02:30 PM
PURPOSE: To determine whether the efficacy of once-daily tiotropium Respimat® (tioR) 5 µg and 2.5 µg is influenced by baseline characteristics in adolescent patients, aged 12-17 years, with moderate symptomatic asthma.
METHODS: A 48-week, Phase III, randomized, double-blind, parallel-group trial (NCT01257230) of once-daily tioR 5 μg, tioR 2.5 μg, or placebo Respimat® (pboR) add-on to medium-dose ICS in adolescent patients (12-14 years: 200-400 µg budesonide or equivalent; 15-17 years: 400-800 µg budesonide or equivalent). Patients had a ≥3-month history of asthma, a pre-bronchodilator FEV1 of ≥60% and ≤90% predicted, and a seven-question Asthma Control Questionnaire score of ≥1.5 at screening, and were non-smokers. The primary endpoint was peak FEV1 within 3 hours post-dosing (peak FEV1(0-3h)) at Week 24; secondary endpoints included trough FEV1 at Week 24; post hoc analyses by selected patient baseline demographics and disease characteristics were performed.
RESULTS: 397 patients were treated: tioR 5 μg n=134, tioR 2.5 μg n=125, pboR n=138; 94.7% of patients completed the treatment period. 54.2% patients were aged 12-14 years, and 45.6% were aged 15-17 years; 42.3% of patients had FEV1 % predicted ≥80% at screening; mean reversibility at screening was 670 ± 300 mL (26.8 ± 12.9%). At Week 24 in the full analysis set, tioR improved both peak FEV1(0-3h) (adjusted mean response vs pboR: 5 µg=174 ± 50 mL; 2.5 µg=134 ± 51 mL; both p<0.01) and trough FEV1 (5 µg=117 ± 54 mL, p=0.03; 2.5 µg=84 ± 56 mL, p=0.13). All improvements were independent of patients’ baseline characteristics (all treatment-by-subgroup interaction p values >0.05), including country/region, gender, race, ethnicity, BMI, disease duration, age at asthma onset, exposure to second-hand smoke, lung function at screening, FEV1 reversibility, leukotriene modifier use at baseline, and potentially allergic asthma (defined by investigator judgment, immunoglobulin E, and blood eosinophils). The incidence of adverse events was comparable in all treatment groups (tioR 5 μg 62.7%; tioR 2.5 μg 63.2%; pboR 59.4%).
CONCLUSIONS: Once-daily tioR add-on to medium-dose ICS consistently improves lung function in adolescent patients with moderate symptomatic asthma, independent of selected baseline characteristics.
CLINICAL IMPLICATIONS: The efficacy of once-daily tiotropium Respimat® add-on therapy in adolescent patients with moderate symptomatic asthma is not affected by asthma phenotype as characterized by patients’ baseline demographics or disease characteristics.
DISCLOSURE: Mark Vandewalker: Grant monies (from industry related sources): Boehringer Ingelheim Thomas Harper: Grant monies (from industry related sources): Boehringer Ingelheim Petra Moroni-Zentgraf: Employee: Boehringer Ingelheim Michael Engel: Employee: Boehringer Ingelheim Reinhold Luehmann: Employee: Boehringer Ingelheim Jonathan Bernstein: Grant monies (from industry related sources): PI for clinical trials
SPIRIVAÂ® (tiotropium) RespimatÂ® is approved for use in asthma in the EU, Japan and many other countries. The indication varies by country. It is currently being reviewed by the US regulatory authorities.