Study findings show tiotropium Respimat^®* well-tolerated and effective in Japanese patients with symptomatic asthma

Burlington, Ontario, June 19 2014 – Results from a Phase III 52 week study, show tiotropium (delivered via Respimat^®*)5µg, a once-daily long-acting anticholinergic bronchodilator, is efficacious and well-tolerated as an add-on treatment in Japanese adults with moderate to severe symptomatic asthma, despite treatment with inhaled corticosteroids (ICS) with or without long-acting beta-2 agonist (LABA).

“Even with available treatments, the extent to which patients’ asthma is controlled continues to be underestimated,” says Dr. Alan Kaplan, Chairperson, Family Physician Airways Group of Canada. “This Phase III data demonstrates the safety and efficacy of tiotropium Respimat^®*, and may lead to another tool in our arsenal against uncontrolled asthma in Canada.”

The primary outcome of this study was long-term safety. The incidence of adverse events (AEs) was similar across treatment groups, with most AEs being mild to moderate in intensity. Drug related AEs occurred in 10 (8.8 per cent), six (5.3 per cent), and three (5.3 per cent) patients in the tiotropium Respimat^®* 5µg, 2.5µg, and placebo groups, respectively.¹ Serious AEs were less frequent with tiotropium Respimat^®* 5μg (n=4, 3.5 per cent) and 2.5 μg (n=4, 3.5 per cent) versus placebo (n=9, 15.8 per cent).¹

The Phase III trial demonstrated that tiotropium Respimat^®* 5µg improved lung function in these patients.¹ The adjusted mean trough forced expiratory volume (FEV₁) response – the amount of air which can be forcibly exhaled from the lungs in the first second of exhalation – was significantly higher with tiotropium Respimat^®* 5µg versus placebo Respimat^®* at weeks 12, 36, and 52 (week 52 difference: 112 mL [95% confidence interval (CI): 0.018, 0.207; p=0.0203]) but not with tiotropium Respimat^®* 2.5 μg.¹

The results of this study show that long-term tiotropium Respimat^®* treatment for 52 weeks demonstrates a safety profile comparable with that of placebo in Japanese patients with moderate to severe symptomatic asthma despite treatment with ICS with or without LABA, as well as improvements in FEV₁.

UNCONTROLLED ASTHMA IN CANADA
•Canada has one of the highest incidences of asthma in the world affecting approximately three million people nationally.²
•Six out of every 10 people with asthma do not have control of their condition.²
•In Canada, asthma is the leading cause of absenteeism from school and the third leading cause of work loss.²
•Despite the progress made, between 250 to 300 Canadians will die from asthma each year.³
•It is estimated that more than 80 per cent of asthma deaths could be prevented with proper asthma education.²

The positive Japanese trial results add to previously reported Phase III PrimoTinA-asthma^® trial data. The Primo TinA-asthma^® clinical trials showed that tiotropium Respimat^®* increased time to first severe exacerbation and first episode of asthma worsening in patients who remain symptomatic despite treatment with ICS and LABA.⁴

 ABOUT TIOTROPIUM RESPIMAT^®* IN ASTHMA*
Tiotropium Respimat^®* is an inhaled long-acting anticholinergic bronchodilator being investigated in asthma to assess its efficacy and safety as add-on treatment for adult patients who are symptomatic on at least ICS with or without LABA therapy. The first data to come from the Phase III clinical trial programme, UniTinA-asthma^®, were the PrimoTinA-asthma^® studies, which demonstrated the efficacy and safety of tiotropium in asthma patients who remained symptomatic despite treatment with ICS and LABA therapy. Data from the PrimoTinA-asthma^® studies have since been published in the New England Journal of Medicine.⁴

ABOUT THE STUDY¹
In this randomized, double-blind, placebo-controlled, Phase III trial across
54 Japanese centres, 285 patients with moderate to severe symptomatic asthma were randomized to receive evening tiotropium Respimat^®* 5µg, 2.5 µg, or placebo, for 52 weeks. In total, 264 patients completed the study.

Eligible patients included: 18 – 75 years of age; never smoked/ex-smokers (≥1 year; <10 packs-years); ≥12-week history of asthma at enrolment; initial asthma diagnosis before age 40; seven-question Asthma Control Questionnaire mean score ≥1.5; forced expiratory volume in one second (FEV) reversibility ≥12 per cent and ≥200mL (15-30 minutes after 400 µg salbutamol); maintenance treatment with medium-dose ICS ± LABA for
≥4 weeks before screening.

Primary endpoint: long-term safety. Secondary endpoints included: trough FEV1, in-clinic peak expiratory flow rate (PEFR) using spirometry.

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