pan>)--Data from the PrimoTinA-asthmaTM Phase III research presented
for the first time today at the 2012 European Respiratory Culture (ERS)
congress show that tiotropium substantially reduced asthma exacerbations
in people who remain symptomatic despite treatment with at least ICSB/LABAC,LeBron 10.One particular
“These results exceeded the expectations. While we were ready for
improvements in lung function while adding tiotropium to usual caution, the
significant reduction in potential risk of exacerbations came as a surprise
especially given that all patients were being already receiving optimal
repair treatment as defined by the GINA guidelines.”
Tiotropium also significantly much better lung function in symptomatic
bronchial asthma patients on ICS/LABA.2
Most of these data are also being released simultaneously online in the Brand-new
England Journal of Medicine sold at http://www.nejm.org.
Professor Huib A M Kerstjens of the University Medical Center,
Groningen, The Netherlands, and lead article author on both studies, said:
These kind of results exceeded our targets. While we were anticipating
advancements in lung function when incorporating tiotropium to usual care, the
significant reduction in the risk of exacerbations arrived as a surprise
especially since all patients were previously receiving optimal
maintenance remedy as defined by the GINA recommendations.
The PrimoTinA-asthmaTM studies were a couple replicate
double-blind parallel-group trials including symptoms of asthma patients with
post-bronchodilator FEV1D >80% predicted along with
asthma control questionnaire credit score 1.5 while on at the least ICS/LABA. A
total of 912 people were randomised to additional tiotropium Respimat
5 various g or placebo for Forty-eight weeks.
The pre-specified co-primary lung function endpoints provided peak and
trough FEV1 at 24 weeks. Adding tiotropium Respimat
provided sizeable lung function improvements at Per day weeks, which were
sustained through 48 weeks.2
With the third co-primary endpoint, in the pre-specified combined
analysis of the two trials, the addition of tiotropium Respimat
ended up being associated with a 21% risk reduction (HR 0.79, P=0.03) throughout
time to first severe exacerbation. Serious exacerbations were defined as
requiring endemic corticosteroids for at least 3 days.1
Furthermore, the addition of tiotropium Respimat reduced a
risk of any asthma exacerbation, based on a significant increase in
symptoms or peak expiratory flow (PEF) drop 30% above 2 days, by 31% (P>0.0001).One particular
There were also significant advancements in asthma control in addition to asthma
related quality of life (assessed by the questionnaires ACQ and AQLQ)
a single trial, and a trend towards improvement in asthma handle in the
other study.A single,2
Despite current treatments, there still remains a strong unmet medical
need in symptoms of asthma, because a significant proportion associated with patients remain
symptomatic and might experience asthma exacerbations.3
UniTinA-asthmaTM Stage III trial programme
regular
The PrimoTinA-asthmaTM studies are part of Boehringer
Ingelheims in depth ongoing Phase III trial offer programme named
UniTinA-asthmaTM, which was created to establish the
efficacy along with safety of tiotropium, delivered by way of the Respimat
SoftMistTM Inhaler (SMI) in patients with allergies.
UniTinA-asthmaTM includes a number of clinical studies within
adults, adolescents and and youngsters (age 1+) with persistent asthma
across the spectrum of bronchial asthma severity. These studies entail over 4000
patients in additional than 150 sites around the world.
Professor Klaus Dugi, Corporate Senior V . p . Medicine,
Boehringer Ingelheim, said: We are enthusiastic by these results, that could
likely be highly appreciated by simply both physicians and individuals. The
UniTinA-asthmaTM trial programme is usually exploring whether
tiotropium can address the clear unmet medical will need seen in the
significant range of asthma patients who remain symptomatic despite the
available remedial options. This programme exhibits our
commitment to develop tiotropium Respimat for a wide range
of asthma patients. These first results impart us with confidence that
tiotropium Respimat has the potential to turn into an important
new option throughout asthma treatment.
European The respiratory system Society Annual Congress This year Boehringer
Ingelheim tiotropium in asthma data
Abstract title:
Tiotropium reduces asthma exacerbations in asthmatic patients
with continual airflow obstruction uncontrolled in spite of treatment
in accordance with guidelines
Poster number:
P1796
Session:
C8, Session 214, 08:30-10:31, Monday, 03 September Next
Abstract title:
Tiotropium provides sustained bronchodilation in asthmatics
with chronic airflow obstruction uncontrolled despite treatment
in accordance with guidelines
Poster amount:
P2187
Session:
Halle A-11, Session 249, 12:50-14:40, Monday, 03 June 2012
A Tiotropium delivered by Respimat is not licensed for the
treatment of asthma
B Inhaled corticosteroids
C Long-acting beta2-agonists
D FEV1 Forced Expiratory Volume level in one second
Ends
Make sure you click on the link below for Notes to Editors: http://www.boehringer-ingelheim.com/news/news_releases/press_releases/20...
Referrals
1. Kerstjens HAM, Engel M, Dahl 3rd thererrrs r, et al. Tiotropium in Symptoms of asthma Poorly
Controlled with Conventional Combination Therapy. N Eng L Med Published
online Several Sept 2012 (www.nejm.net).
2. Kerstjens HAM, Paggiaro PL, Vandewalker et ing. Tiotropium provides
sustained bronchodilation in asthma sufferers with persistent airflow
congestion uncontrolled despite treatment as outlined by
guidelines. ERS 2012 abstract P2187.
3. Rabe, KF, Vermeire, PA, Soriano, JB, et ing Clinical management of
asthma throughout 1999: the Asthma Experience in Europe (AIRE) study.Eur Breath J
2000; 16, 802-807.
Four. Global Initiative for All about asthma (GINA). http://www.ginasthma.org/Questions-and-answers/q-a-general-information-a...
[Last Accessed 19/06/12].
5. World Health and fitness Organization. WHO factsheet 206: bronchial asthma.
At: www.who.int/mediacentre/factsheets/fs206/en
[Last Accessed 19/06/12].
7. European Federation of Allergy along with Airway Diseases Patients
Connection. http://www.efanet.org/asthma/index.html
[Last Accessed 19/06/12].
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published in 2003 [Last Used 19/06/12],LeBron X.
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asthma in children and grownups: the global asthma insights plus reality
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9,Nike LeBron 10. Dhand R. Aerosol Plumes: Slow and Steady Wins The Competition. J Aerosol
Med 2005; 18(3): 261-63.
10. Hochrainer D, Hlz They would. Comparison of Aerosol Velocity along with Spray
Duration of Respimat Soft MistTM Inhaler plus
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Eleven. Freytag F, Golisch W, Wolf Okay. New soft mist inhaler works and
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12. Brand P et aussi al. Respimat Soft MistTM inhaler
preferred in order to Diskus by Patients with COPD plus /or Asthma. J
Aerosol Med The year 2007; 20(2): 165.
13. Hodder R, Price D. Affected person Preference for Inhaler Devices throughout Chronic
Obstructive Pulmonary Disease: Exposure to Respimat Soft MistTM
Inhaler. Int J Chronic Obstruct Pulm Dis 2009; 4: 381-390.
14. Hodder 3rd thererrrs r, Reese PR, Slaton T. Asthma Sufferers Prefer Respimat Soft
MistTM Inhaler to Turbohaler. Int C Chronic Obstruct Pulm
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