- The world’s largest randomized
pragmatic trial to study the impact of treatments on COPD
exacerbations
- Study will compare time to first COPD
exacerbation for patients treated with combination LABA/LAMA and
those treated with triple combination LABA/LAMA/ICS
The first patients have now enrolled in AIRWISE, the world’s
largest ever pragmatic clinical trial in chronic obstructive
pulmonary disease (COPD) to study how commonly prescribed medicines
may reduce the occurrence of exacerbations of COPD.
This landmark research is a collaboration between Anthem, Inc.,
its outcomes research subsidiary, HealthCore, Inc. and Boehringer
Ingelheim, a pharmaceutical company with a long history of
leadership in respiratory research worldwide.
The AIRWISE trial will further inform the scientific community’s
understanding of the role of long-acting muscarinic antagonists
(LAMA), long-acting ß-agonists (LABA) and inhaled corticosteroids
(ICS) in reducing the risk of COPD exacerbations. Whether or not an
ICS provides a meaningful benefit in reducing COPD exacerbations,
in addition to a LAMA and a LABA, is currently a topic of
scientific debate. Results from the trial will be available in
2020.
“We’re pleased to offer our affiliated health plan members and
their healthcare providers the opportunity to participate in this
pioneering trial that is designed to answer an important scientific
question,” said Dr. Mark Napier, medical director for Anthem, Inc.,
who participated in the trial’s design. “As a pulmonologist, I am
particularly interested in how AIRWISE will provide real-world data
on a broad population of COPD patients that cannot be obtained from
traditional randomized clinical trials. This will be invaluable for
clinicians and health care organizations alike. Anthem’s national
size and depth help to broaden the reach of the trial and will make
the evidence more robust.”
A COPD exacerbation, or a flare-up, is a sudden worsening
of symptoms, such as increased breathlessness, cough, mucus
production and extreme fatigue. Exacerbations are serious and can
lead to permanent reductions in lung function, hospitalization or
even death. Exacerbations can often cause COPD to progress more
quickly making their prevention very important. In addition to the
detrimental effects on patients’ health, COPD exacerbations
increase the burden on the healthcare system as a whole.
The AIRWISE trial will compare the effectiveness of STIOLTO®
RESPIMAT® (tiotropium bromide & olodaterol) Inhalation Spray,
the fixed-combination of tiotropium (a LAMA) and olodaterol (a
LABA), with any commercially available triple combination of a
LAMA, a LABA and an ICS in a real-world setting. The 52-week,
randomized, open-label trial will enroll 3,200 adults with COPD
whose healthcare provider has assessed that they are not controlled
with their current therapy of a LAMA, a LABA or an ICS/LABA.
The primary endpoint of AIRWISE is the time to first moderate or
severe COPD exacerbation. Other measurements include comparing the
annual rate of moderate or severe COPD exacerbations and comparing
all-cause and COPD-related healthcare resource utilization,
including inpatient admissions, emergency room visits, outpatient
encounters and office visits. For more information, please visit
ClinicalTrials.gov (NCT03265145).
“Due to the significant impact of exacerbations on the health of
people with COPD, it is critical that their occurrence is reduced
with the safest and most effective treatment plans,” said Thomas
Seck, M.D., vice president, Clinical Development and Medical
Affairs, Primary Care, Boehringer Ingelheim Pharmaceuticals, Inc.
“Our partnership with Anthem and HealthCore is an important
initiative to help healthcare providers understand how two
treatment approaches work in the real-world to reduce the
occurrence of exacerbations. It is essential that patients are
prescribed appropriate treatments and that they are not
over-treated with drugs that may provide no additional benefit and
may have additional side-effects.”
“We are thrilled and proud to be part of this landmark study
that will help to evolve our understanding of COPD and its
treatment,” said Vince Willey, PharmD, HealthCore staff vice
president. “Moving forward, we hope that AIRWISE becomes a
trailblazer for further pragmatic trials that inform patients,
doctors, caregivers, life science companies and those who make
health policy decisions. We believe it is important that everyday
health decisions are based not only on data from traditional
clinical trials, but also on data from real-world settings.”
In 2014, Anthem and Boehringer Ingelheim announced the beginning
of a multi-year research collaboration to identify and address
unmet medical needs across populations of mutual interest.
Together, the companies are seeking to better serve patients and
healthcare providers by exploring issues related to appropriate use
of existing and new therapies and interventions, and the impact
these have on clinical and economic outcomes.
About COPD
Chronic obstructive pulmonary disease is a term that includes
chronic bronchitis and/or emphysema. This disease can make
breathing harder because less air is able to flow in and out of the
lungs. Chronic lower respiratory diseases, which include COPD, are
the third leading cause of death in the United States, and
approximately 15 million Americans have been told by a healthcare
provider that they have COPD.
The most common symptom of COPD is shortness of breath,
especially with physical activities. Coughing, with or without
mucus production, is also a common symptom of COPD. These symptoms
can be misunderstood as signs of aging. COPD is usually associated
with progressive airway damage and loss that cause breathing to get
more difficult.
INDICATION for STIOLTO RESPIMAT
STIOLTO RESPIMAT (tiotropium bromide and olodaterol) Inhalation
Spray is a prescription medicine used long term, two puffs once
each day, in controlling symptoms in adults with chronic
obstructive pulmonary disease (COPD). COPD is a chronic lung
disease that includes chronic bronchitis, emphysema, or both.
STIOLTO contains the anticholinergic, tiotropium and the
long-acting beta2-adrenergic agonist (LABA), olodaterol. STIOLTO
works by helping the muscles around the airways in your lungs stay
relaxed to prevent symptoms, such as wheezing, cough, chest
tightness and shortness of breath.
STIOLTO is not for treating sudden symptoms of COPD. Always have
a rescue medicine with you to treat sudden symptoms. If you do not
have a rescue inhaler, contact your healthcare provider to have one
prescribed for you.
Do not use STIOLTO if you have asthma. STIOLTO is approved to
treat COPD only.
IMPORTANT SAFETY INFORMATION
People with asthma who take long-acting
beta2-agonist (LABA) medicines, such as olodaterol,
(one of the medicines in STIOLTO), have an increased risk of death
from asthma problems. It is not known if LABA medicines, such as
olodaterol (one of the medicines in STIOLTO), increase the risk of
death in people with COPD. STIOLTO has been approved for chronic
obstructive pulmonary disease (COPD) only. STIOLTO is NOT to be
used in asthma.
Do not use STIOLTO if you are allergic to tiotropium,
ipratropium, atropine or similar drugs, olodaterol or any
ingredient in STIOLTO. Symptoms of a serious allergic reaction may
include rash, hives, swelling of the face, mouth, and tongue and
breathing problems. Call your healthcare provider or get emergency
medical care if you get any symptoms of a serious allergic
reaction. Do not use STIOLTO for treating sudden breathing
problems. Always have a rescue inhaler with you to treat sudden
symptoms.
Do not use STIOLTO more often or at higher doses than prescribed
by your doctor. Do not use STIOLTO with other LABAs or
anticholinergics. Get emergency medical care if your breathing
problems worsen quickly or if you use your rescue inhaler but it
does not relieve your breathing problems. Call your healthcare
provider if breathing problems worsen over time while using
STIOLTO.
Tell your doctor about all your medical conditions including
heart problems, high blood pressure, seizures, thyroid problems,
diabetes, kidney problems, glaucoma, enlarged prostate and problems
passing urine.
Tell your doctor about all the medicines you take, including
prescription and non-prescription medicines (including eye drops),
vitamins and herbal supplements. STIOLTO may interact with other
medicines which may cause serious side effects.
STIOLTO can cause serious side effects, including sudden
shortness of breath that may be life threatening, fast or irregular
heartbeat, increased blood pressure, chest pain, high blood sugar
or low blood potassium that may cause muscle spasms or weakness or
abnormal heart rhythm. If any of these happens, stop taking STIOLTO
and seek immediate medical help.
STIOLTO can cause new or worsening eye problems including
narrow-angle glaucoma, and can increase the pressure in your eyes,
which can cause the following symptoms: eye pain, blurred vision,
seeing halos or colored images along with red eyes. If you have any
of these symptoms, stop taking your medicine and call your doctor
right away.
STIOLTO can cause new or worsened urinary retention. Symptoms of
urinary retention may include difficulty passing urine, painful
urination, urinating frequently or urinating in a weak stream or
drips. If you have any of these symptoms, stop taking your medicine
and call your doctor right away.
STIOLTO is for oral inhalation only. The STIOLTO cartridge is
only intended for use with the STIOLTO RESPIMAT inhaler.
Do not spray STIOLTO into your eyes.
The most common side effects of STIOLTO are runny nose, cough
and back pain.
Tell your healthcare provider about any side effect that bothers
you or that does not go away.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call
1-800-FDA-1088.
Read the step-by-step patient Instructions for Use for STIOLTO
RESPIMAT before you use your inhaler.
Please see accompanying Medication Guide, Instructions for Use
and Full Prescribing Information, including boxed WARNING.
About Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield,
CT, is the largest U.S. subsidiary of Boehringer Ingelheim
Corporation.
Boehringer Ingelheim is one of the world’s 20 leading
pharmaceutical companies. Headquartered in Ingelheim, Germany, the
company operates globally with 145 affiliates and more than 47,000
employees. Since its founding in 1885, the family-owned company has
been committed to researching, developing, manufacturing and
marketing novel treatments for human and veterinary medicine.
Boehringer Ingelheim is committed to improving lives and
providing valuable services and support to patients and their
families. Our employees create and engage in programs that
strengthen our communities. To learn more about how we make more
health for more people, visit our Corporate Social Responsibility
Report.
In 2015, Boehringer Ingelheim achieved net sales of about $15.8
billion (14.8 billion euros). R&D expenditure corresponds to
20.3 percent of its net sales.
For more information please visit
www.us.boehringer-ingelheim.com, or follow us on Twitter
@BoehringerUS.
About Anthem, Inc.
Anthem is working to transform health care with trusted and
caring solutions. Our health plan companies deliver quality
products and services that give their members access to the care
they need. With over 74 million people served by its affiliated
companies, including more than 40 million within its family of
health plans, Anthem is one of the nation’s leading health benefits
companies. For more information about Anthem’s family of companies,
please visit www.antheminc.com/companies.
About HealthCore Inc.
HealthCore Inc., www.healthcore.com, uses real world data,
including claims information, to provide clinical and other
scientific expertise and research services to the pharmaceutical,
biotechnology and device industries, in the conduct of
industry-sponsored safety, health economic outcomes, comparative
effectiveness, epidemiological and late stage research projects.
HealthCore’s capabilities include retrospective database design and
analysis, prospective observational research design and analysis,
safety and epidemiologic research services, post authorization
safety study (PASS), health services research, patient and/or
provider survey development and implementation and general research
consultation.
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version on businesswire.com: http://www.businesswire.com/news/home/20171005005265/en/
Boehringer Ingelheim Pharmaceuticals, IncChris WahlersEmail:
christopher.wahlers@boehringer-ingelheim.comPhone:
203-798-4375orAnthem, Inc.Lori McLaughlinEmail:
Lori.McLaughlin2@anthem.comPhone: 317-407-7403
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