INGELHEIM, Germany--(BUSINESS WIRE)--Boehringer Ingelheim today announced the publication of new data from
the Phase IIIb OTEMTO® 1&2 trials (NCT01964352/NCT02006732),
which show Spiolto® Respimat®
(tiotropium/olodaterol) provides consistent, clinically meaningful
improvements in quality of life versus placebo in patients with COPD*. Norvir (Ritonavir) with no Rx
These data are published online in the journal Respiratory Medicine.1
For COPD patients, breathlessness, among other symptoms, limits their
ability to keep active and has a negative impact on their daily lives. Buy Intagra (Sildenafil Citrate) without Rx
As there is no cure for COPD, improving quality of life is a major goal
of treatment. Prometrium (Progesterone) without prescription In COPD, quality of life is measured using the SGRQ†;
a reduction in SGRQ score of 4 points or more is deemed clinically
meaningful.2 The OTEMTO® trials show Spiolto®
Respimat® provides a reduction in SGRQ total score of 4.67‡
versus placebo.
“The improvement in quality of life provided by Spiolto®
Respimat® in these trials could make a noticeable difference
to the daily activity of COPD patients and enable them to maintain a
more independent life,” said Dave Singh, Professor of clinical
pharmacology and respiratory medicine, University of Manchester and lead
investigator of the OTEMTO® trials. Doxazosin with free prescription “For example, this could
mean that patients are able to walk up stairs without stopping, go out
to socialise with friends or find it easier to wash and dress. Super Pack () with free Rx
Essentially, the data show that patients feel much better.”
Further data from the 1,600 patient OTEMTO® trials show
Spiolto® Respimat® provides:
clinically meaningful improvements in breathlessness compared to
placebo (measured by a 1.62 point improvement in TDI focal score§),
reflecting the meaningful quality of life benefits
consistent improvements in lung function, breathlessness and quality
of life compared to Spiriva® (tiotropium)
a safety profile similar to Spiriva® or placebo. Buy Weightlifting Belts online Incidence
of adverse events (AEs) was broadly similar across treatment groups,
with a higher incidence of AEs leading to discontinuation in the
placebo groups compared to the treatment groups
OTEMTO® 1&2 build on the pivotal phase III TONADO® trials
that demonstrated Spiolto® Respimat® provides
significant improvements in lung function, breathlessness, quality of
life and reduction in rescue medication use over Spiriva®
Respimat® right from the initial disease stages when patients
first need maintenance therapy.3,4 OTEMTO® 1&2 are
part of the >15,000 patient TOviTO® Phase III clinical
trial programme, one of the largest trial programmes conducted in COPD.
U.S. http://anti-infectives-opinion.blogspot.com Food and Drug Administration (FDA) recently accepted for review a
Supplemental New Drug Application (sNDA) to include the OTEMTO® quality
of life data in the Stiolto™ Respimat®** label.
For further information visit: newscentre.boehringer-ingelheim.com/education_hub1/respiratory.html
OTEMTO® Respiratory Medicine publication: dx.doi.org/10.1016/j.rmed.2015.08.002
About Spiolto® Respimat®
To date, Spiolto® Respimat® has gained approval in
more than 20 EU/EEA countries, the US, Canada and Australia for use in
the treatment of patients with COPD.
Spiolto® Respimat® is built on tiotropium, the
active ingredient in Spiriva® - the world’s most prescribed
COPD maintenance treatment with over 40 million patient years of real
life experience across all COPD severities.5 It is enhanced
by olodaterol††, a unique and effective long-acting
beta2-agonist with a fast onset of action,6 specifically
designed to complement the efficacy of Spiriva®. Spiolto®
is delivered by Respimat®, the only inhaler available that
actively‡‡ delivers a unique mist, meaning the patient just
needs to breathe in naturally for the medication to go deep into the
lungs.7-13
Intended audiences
This press release is issued from our Corporate Headquarters in
Ingelheim, Germany and is intended to provide information about our
global business. Please be aware that information relating to the
approval status and labels of approved products may vary from country to
country, and a country-specific press release on this topic may have
been issued in the countries where we do business.
For ‘Notes to Editors’ and ‘References’ please visit: .boehringer-ingelheim.com/news/news_releases/press_releases/2015/17_august_2015_copd.html
* Chronic obstructive pulmonary disease
† St George’s Respiratory Questionnaire (SGRQ), a
disease-specific patient-reported instrument that evaluates symptoms
including frequency and duration of cough, wheezing and breathlessness
‡ SGRQ total score after 12 weeks of treatment in the
combined data set of the 2 replicate studies OTEMTO®1 and OTEMTO® 2
§ Transition dyspnoea index focal score after 12 weeks of
treatment in the combined data set
** Spiolto® Respimat® is marketed as Stiolto™ Respimat® in
the US and Inspiolto™ Respimat® in Canada
†† Marketed as Striverdi® Respimat®
‡‡ Respimat® delivers a metered dose of medication in a mist
at the push of a button not requiring the force from the patient’s
inhalation
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