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Phase III Data Presented for First Time Demonstrate: Tiotropium* Respimat Significantly Improves Lung Function and Provides Sustained Bronch
|BARCELONA, Spain - Monday, September 9th 2013 [ME NewsWire]|
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ERS Congress 2013
Addition of tiotropium Respimat® provides statistically significant and clinically relevant improvement in asthma control in symptomatic asthma patients receiving ICS† therapy2
New phase III data presented for the first time demonstrate the efficacy of tiotropium in asthma patients receiving ICS therapy.2 These results add to evidence from the on-going Phase III trial programme that had shown efficacy and safety of tiotropium in patients who remained symptomatic despite treatment with at least ICS/LABA‡3
At least 40% of asthma patients remain symptomatic despite current standard treatment options and may experience asthma exacerbations (attacks)4
In patients with symptomatic asthma despite moderate-dose maintenance ICS therapy, the addition of tiotropium Respimat® significantly improves lung function and provides sustained bronchodilation over 24 hours.1
Data from the MezzoTinA-asthma® Phase III twin studies presented for the first time today at the 2013 European Respiratory Society (ERS) congress also show that once-daily tiotropium provides a statistically significant and clinically relevant improvement in asthma control in patients who remain symptomatic despite treatment with ICS.2
Assessment of the severity of asthma in patients is now commonly based on the intensity of treatment needed to achieve good management of symptoms.5 These new data add to evidence from the PrimoTinA-asthma® Phase III trials involving patients who remained symptomatic despite at least ICS/LABA therapy. The PrimoTinA-asthma® trials had shown that the addition of tiotropium Respimat® significantly increased time to first severe asthma exacerbation, as well as time to first episode of asthma worsening compared with standard care.3
Professor Huib A M Kerstjens of the University Medical Centre, Groningen, The Netherlands said: "These results are important because they give us insight for the first time into the efficacy of tiotropium in the subset of asthma patients who remain symptomatic despite using moderate-dose ICS. A significant proportion of asthma patients treated with ICS, as recommended in the guidelines, continue to experience symptoms that impact their ability to lead a full life.”
"Importantly, both for physicians and their patients, these data show that the addition of tiotropium may provide improvements in asthma control and lung function that are clinically meaningful. I was personally amazed at how well these results compare to the treatment with the LABA in the active control arm. These data increase our understanding of tiotropium’s potential efficacy across asthma severities as an add-on treatment for patients who continue to experience symptoms despite current standard treatments,” concluded Professor Kerstjens.
Despite current treatment options, at least 40% of patients with asthma remain symptomatic and may experience frightening and potentially life-threatening asthma exacerbations (attacks).4 All patients in the MezzoTinA-asthma® studies were symptomatic despite moderate dose ICS therapy.
Addition of tiotropium in asthma significantly improves lung function
The MezzoTinA-asthma® Phase III studies have shown that, in patients with symptomatic asthma, tiotropium Respimat® added on to moderate-dose ICS significantly improved lung function endpoints, including peak FEV1 (0-3h) and trough FEV1 vs. placebo and provided sustained bronchodilation over 24 hours.
In MezzoTinA-asthma® 1, at week 24, all three active treatments significantly improved peak FEV1 (0-3h) response§ vs. placebo: differences of 236 mL for tiotropium 2.5μg once-daily; 198 mL for tiotropium 5μg once-daily and 213 mL for salmeterol 50μg twice daily (all p<0.0001). In MezzoTinA-asthma® 2, at 24 weeks, the peak FEV1 response vs. placebo was again significantly higher for all three active treatments: differences of 211 mL for tiotropium 2.5μg once-daily, 169 mL for tiotropium 5μg once-daily and 176 mL for salmeterol 50μg twice-daily (all p<0.0001).1
In MezzoTinA-asthma® 1, at week 24, all three active treatments significantly improved trough FEV1 response** vs. placebo: differences of 185 mL for tiotropium 2.5μg once-daily; 152 mL for tiotropium 5μg once-daily and 123 mL for salmeterol 50μg twice-daily (all p<0.0001). In MezzoTinA-asthma® 2, at 24 weeks, trough FEV1 response vs. placebo was again significantly improved for all three active treatments: differences of 176 mL for tiotropium 2.5μg once-daily, 133 mL for tiotropium 5μg once-daily and 106 mL for salmeterol 50μg twice-daily (p≤0.0002).1
Addition of tiotropium in asthma achieves significant and clinically relevant improvements in asthma control
The MezzoTinA-asthma® Phase III studies have shown that tiotropium added on to moderate-dose ICS significantly improved asthma control in patients with asthma who are symptomatic on ICS.
The mean baseline Asthma Control Questionnaire (ACQ) total score was 2.18 (SD 0.49). Using a definition of responders as those patients with an improvement ≥0.5 for the ACQ, both doses of tiotropium significantly improved the ACQ responder rate at 24 weeks compared with placebo. A similar ACQ responder rate was observed with tiotropium and the active comparator the LABA salmeterol.2
The ACQ responder rate for placebo was 57.7% (299/518); 64.5% (332/515; p=0.03) for tiotropium 2.5μg once-daily; 64.3% (330/513; p=0.03) for tiotropium 5μg once-daily; and 66.5% (356/535; p=0.004) for salmeterol 50μg twice-daily.2
Tiotropium well tolerated
In the MezzoTinA-asthma® Phase III studies, tiotropium Respimat® was well tolerated in patients with asthma who were symptomatic on ICS.1
Discontinuations due to adverse events (AEs) were 2.5% in the placebo group; 1.2% for tiotropium 2.5μg once-daily; 1.7% for tiotropium 5μg once-daily; and 1.8% for salmeterol 50μg twice-daily.
The overall frequency of AEs and serious adverse events (SAEs) was balanced between the groups. The most common adverse events were asthma (exacerbations) and decreased peak expiratory flow, which were comparable between the treatment groups. Dry mouth, cough and dysphonia (hoarseness) occurred in less than 2% of patients taking tiotropium.
"The results from the MezzoTinA-asthma® twin trials demonstrate tiotropium’s efficacy in an even broader range of asthma patients. They add to the significant evidence we have from the PrimoTinA-asthma® Phase III clinical trials, which had previously shown the efficacy and safety of tiotropium in asthma patients who remained symptomatic despite treatment with at least ICS/LABA therapy,” said Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim.
"The UniTinA-asthma® programme reflects our commitment to profile tiotropium Respimat® for the full range of asthma patients from mild to very severe across all age groups,” Professor Dugi continued. "These new data give us confidence that tiotropium could become an important new add-on treatment option for those patients with asthma who remain symptomatic despite current standard treatments, which include ICS therapy,” he concluded.
Please click on the link below for ‘Notes to Editors’ and ‘References’: http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2013/09_september_2013tina.html
* Please note: Tiotropium Respimat® is currently NOT APPROVED for use in asthma. Tiotropium’s safety and efficacy have not yet been fully established in asthma
† Inhaled corticosteroids
‡ Long-acting beta2-agonists
§ Difference between the maximum FEV1 measured within the first 3 hours post dosing and the FEV1 measurement at baseline (10 minutes before the first dose of trial medication)
** Difference between the trough FEV1 measured at the end of the dosing interval (24 hours post drug administration) and the FEV1 measurement at baseline (10 minutes before the first dose of trial medication)
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