SESSION TITLE: Tiotropium and Asthma
SESSION TYPE: Original Investigation Slide
PRESENTED ON: Monday, October 28, 2013 at 01:45 PM - 03:15 PM
PURPOSE: To evaluate the safety of once-daily tiotropium (5 µg in the morning via Respimat® Soft Mist™ Inhaler) for patients with symptomatic asthma despite standard treatment with ICS+LABA.
METHODS: In two replicate, double-blind, placebo-controlled studies (NCT00772538; NCT00776984), eligible patients (aged 18-75 years) had: ≥5-year history of asthma diagnosed before aged 40 years; Asthma Control Questionnaire 7 score ≥1.5; experienced ≥1 exacerbation during the previous year. Patients were either life-long non-smokers or ex-smokers (<10 pack-years) who quit smoking ≥1 year before study enrollment. Safety endpoints were incidence and intensity of adverse events (AEs), and changes in vital signs and clinical laboratory findings. Pre-planned pooled analysis of AE data was performed.
RESULTS: 912 patients were randomized to receive 48 weeks of treatment with either tiotropium (n=456) or placebo (n=456). Mean treatment exposure was similar for tiotropium (319 days) and placebo (319 days) patients. A lower incidence of AEs was reported in tiotropium (73.5%) versus placebo (80.3%) patients. Most commonly reported AEs were asthma deterioration (tiotropium 39.9%; placebo 50.9%), reduced peak expiratory flow rate (tiotropium 20.4%; placebo 26.8%), and nasopharyngitis (tiotropium 11.2%; placebo 12.3%). A similar proportion of tiotropium versus placebo patients experienced drug-related AEs (5.7% vs 4.6%), severe AEs (12.5% vs 11.6%), and serious AEs (8.1% vs 8.8%). Generally, drug-related AEs were mild to moderate in intensity; a low incidence of dry mouth was reported (tiotropium 1.3%; placebo 0.4%). Incidence of AEs leading to discontinuation of study medication was low and comparable between treatment groups (tiotropium 1.8%; placebo 3.1%). No deaths were reported. Vital signs and clinical laboratory findings were comparable between treatment groups in individual studies, with no marked changes.
CONCLUSIONS: The safety profile for once-daily 5 µg tiotropium via Respimat® Soft Mist™ Inhaler was generally comparable with placebo during 48 weeks of treatment. Add-on tiotropium was well tolerated in asthmatic patients who were symptomatic with ICS+LABA.
CLINICAL IMPLICATIONS: The safety and tolerability of tiotropium in asthma appear similar to placebo. Funding: Boehringer Ingelheim and Pfizer. Editorial assistance: Complete HealthVizion.
DISCLOSURE: Jonathan A Bernstein: University grant monies: Bernstein clinical research PI U.C. UCP Immunology. BI research studies, Consultant fee, speaker bureau, advisory committee, etc.: BI travel expenses, Consultant fee, speaker bureau, advisory committee, etc.: Teva speaker bureau, Fiduciary position (of any organization, association, society, etc, other than ACCP: Journal of Asthma Editor-In-Chief Huib AM Kerstjens: University grant monies: Board membership - Pfizer, Almirall, GlaxoSmithKline, Takeda, Novartis, Nycomed, Chiesi, Consultant fee, speaker bureau, advisory committee, etc.: Consultancy fee - Pfizer, Almirall, GlaxoSmithKline, Novartis, Nycomed, Chiesi, AstraZeneca, Protaffin, Consultant fee, speaker bureau, advisory committee, etc.: Speaker bureau - BI, Pfizer Petra Moroni-Zentgraf: Employee: BI Michael Engel: Employee: BI Hendrik Schmidt: Employee: BI David MG Halpin: Consultant fee, speaker bureau, advisory committee, etc.: Support to attend International Academic Meetings, Consultant fee, speaker bureau, advisory committee, etc.: Occasional national & International Advisory Board work., Consultant fee, speaker bureau, advisory committee, etc.: Sponsorship to attend International Respiratory Society meetings, Consultant fee, speaker bureau, advisory committee, etc.: Fees for lecturing at educational meetings on asthma
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