pan>)--Data from the PrimoTinA-asthmaTM Phase III scientific tests presented
for the first time today at the 2012 European Respiratory Community (ERS)
congress show that tiotropium significantly reduced asthma exacerbations
in individuals who remain symptomatic regardless of treatment with at least ICSB/LABAC.One
“These results exceeded all of our expectations. While we were anticipating
improvements in lung function whenever adding tiotropium to usual proper care, the
significant reduction in the possibility of exacerbations came as a surprise
especially given that all patients have been already receiving optimal
routine maintenance treatment as defined by your GINA guidelines.”
Tiotropium also significantly enhanced lung function in symptomatic
asthma attack patients on ICS/LABA.2
These types of data are also being printed simultaneously online in the New
England Journal of Medicine offered at http://www.nejm.org.
Professor Huib A T Kerstjens of the University Medical Centre,
Groningen, The Netherlands, and lead author on both studies, said:
These kind of results exceeded our targets. While we were anticipating
upgrades in lung function when contributing tiotropium to usual care, your
significant reduction in the risk of exacerbations arrived as a surprise
especially considering the fact that all patients were by now receiving optimal
maintenance treatment as defined by the GINA rules.
The PrimoTinA-asthmaTM studies were two replicate
double-blind parallel-group trials including asthma patients with
post-bronchodilator FEV1D >80% predicted in addition to
asthma control questionnaire credit score 1.5 while on at least ICS/LABA. A
total of 912 people were randomised to additional tiotropium Respimat
Your five g or placebo for Forty eight weeks.
The pre-specified co-primary lung function endpoints provided peak and
trough FEV1 at Twenty four hours weeks. Adding tiotropium Respimat
provided important lung function improvements at Twenty four hours weeks, which were
sustained more than 48 weeks.2
With the third co-primary endpoint, in the pre-specified combined
analysis of the two trials, the addition of tiotropium Respimat
was associated with a 21% risk reduction (An hour 0.79, P=0.03) inside
time to first severe exacerbation. Extreme exacerbations were defined as
requiring systemic corticosteroids for at least 3 days.Just one
Furthermore, the addition of tiotropium Respimat reduced this
risk of any asthma exacerbation, defined by a significant increase in
symptoms and also peak expiratory flow (PEF) drop 30% more than 2 days, by 31% (P>0.0001).Just one
There were also significant advancements in asthma control plus asthma
related quality of life (looked at by the questionnaires ACQ and AQLQ)
available as one trial, and a trend towards improvement in asthma management in the
other study.Just one,2
Despite current treatment plans, there still remains a good unmet medical
need in allergies, because a significant proportion regarding patients remain
symptomatic and may experience asthma exacerbations.3
UniTinA-asthmaTM Point III trial programme
constant
The PrimoTinA-asthmaTM studies are part of Boehringer
Ingelheims extensive ongoing Phase III tryout programme named
UniTinA-asthmaTM, which was meant to establish the
efficacy in addition to safety of tiotropium, delivered by way of the Respimat
SoftMistTM Inhaler (SMI) in patients with allergies.
UniTinA-asthmaTM includes a number of clinical studies in
adults, adolescents and and children (age 1+) with persistent bronchial asthma
across the spectrum of asthma attack severity. These studies require over 4000
patients in many than 150 sites worldwide.
Professor Klaus Dugi, Corporate Senior Vp Medicine,
Boehringer Ingelheim, said: We are energized by these results, that may
likely be highly appreciated simply by both physicians and patients. The
UniTinA-asthmaTM trial programme is definitely exploring whether
tiotropium can handle the clear unmet medical want seen in the
significant amount of asthma patients who continue being symptomatic despite the
available therapeutic options. This programme demonstrates our
commitment to develop tiotropium Respimat for any wide range
of asthma people. These first results provide us confidence that
tiotropium Respimat has the potential to turn out to be an important
new option with asthma treatment.
European Respiratory : Society Annual Congress This year Boehringer
Ingelheim tiotropium in asthma data
Contemporary title:
Tiotropium reduces asthma exacerbations around asthmatic patients
with persistent airflow obstruction uncontrolled even with treatment
in accordance with guidelines
Poster number:
P1796
Session:
C8, Session 214, 08:30-10:25, Monday, 03 September 2012
Abstract title:
Tiotropium provides experienced bronchodilation in asthmatics
with continual airflow obstruction uncontrolled despite treatment
in accordance with guidelines
Poster amount:
P2187
Session:
Halle A-11, Session 249, 14:50-14:40, Monday, 03 Sept 2012
A Tiotropium delivered simply by Respimat is not licensed for the
treating asthma
B Inhaled adrenal cortical steroids
C Long-acting beta2-agonists
D FEV1 Forced Expiratory Quantity in one second
Ends
You need to click on the link below for Notes to Editors: http://www.boehringer-ingelheim.com/news/news_releases/press_releases/20...
Sources
1. Kerstjens HAM, Engel M, Dahl R, et al. Tiotropium in Asthma Poorly
Controlled with Conventional Combination Therapy. N Eng T Med Published
online A few Sept 2012 (www.nejm.net).
2. Kerstjens HAM, Paggiaro PL, Vandewalker et alabama. Tiotropium provides
sustained bronchodilation in asthmatics with persistent airflow
obstructions uncontrolled despite treatment prior to
guidelines. ERS 2012 contemporary P2187.
3. Rabe, KF, Vermeire, PA, Soriano, JB, et 's Clinical management of
asthma within 1999: the Asthma Skills in Europe (AIRE) study.Eur Respir J
2000; 16, 802-807.
Several. Global Initiative for Asthma (GINA). http://www,cheap beats by dre.ginasthma.org/Questions-and-answers/q-a-general-information-a...
[Last Accessed 19/06/12].
5. World Health Organization. WHO factsheet 206: bronchial asthma.
At: www.who.int/mediacentre/factsheets/fs206/en
[Last Accessed 19/06/12].
Half-dozen. European Federation of Allergy in addition to Airway Diseases Patients
Association. http://www.efanet.org/asthma/index.html
[Last Accessed 19/06/12].
7. http://www.ginasthma.org/pdf/GINABurdenReport.pdf file
published in 2003 [Last Utilized 19/06/12].
8. Rabe KF, Adachi M, Lai CK et al. Worldwide severity and control of
asthma in children and older people: the global asthma insights as well as reality
surveys. J Allergy or intolerance Clin Immunol. 2004; 114(1): 40-7.
9. Dhand Ur,cheapest beats by dre. Aerosol Plumes: Slow and Steady Wins The Contest. J Aerosol
Med 2005; Eighteen(3): 261-63.
10. Hochrainer D, Hlz H. Comparison of Aerosol Velocity as well as Spray
Duration of Respimat Soft MistTM Inhaler along with
Pressurized Metered Dose Inhalers. J Aerosol Mediterranean sea 2005; 18(3):
273-282.
Eleven. Freytag F, Golisch W, Wolf K. New soft mist inhaler is effective and
easy to use in people with asthma and COPD. Eur Breath J
2005;26(Suppl 1949):338s.
12. Brand P et aussi al. Respimat Soft MistTM inhaler
preferred to Diskus by Patients with COPD and also /or Asthma. J
Aerosol Med 3 years ago; 20(2): 165.
13. Hodder R, Price D. Patient 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 R, Reese PR, Slaton T. Asthma Sufferers Prefer Respimat Soft
MistTM Inhaler to Turbohaler. Int L Chronic Obstruct Pulm
Dis 2009; Several: 225-232.
15. Schuermann W, Schmidtmann S, Moroni Delaware, et al. Respimat Soft MistTM
Inhaler as opposed to hydrofluroalkane metered dose inhaler: patient preference
as well as satisfaction. Treatm Respir Med 2006; 4: 53-61.
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