Results from the study showed adults and
children aged 13 and older with uncontrolled asthma using the
ProAir Digihaler and its integrated system had 85.3% higher odds of
improving their asthma control after three months compared with
those using standard of care albuterol inhalers
Physicians reported more interactions with
patients on poor inhaler technique based on objective data from the
Digihaler System versus standard of care
CONNECT1 is the first clinical study to
evaluate ProAir Digihaler and its integrated system compared to
standard of care, and the first to evaluate the Digihaler system in
asthma control
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical
Industries Ltd. (NYSE and TASE: TEVA), today announced that full
results from the CONNECT1 study evaluating the ProAir® Digihaler®
(albuterol sulfate) Inhalation Powder and the Digihaler System in
the management of asthma patients compared to standard of care
(SoC) albuterol reliever therapy, were published online ahead of
print in The Journal of Allergy and Clinical Immunology: In
Practice. The study found patients who used the ProAir Digihaler
had reductions in weekly average daily short-acting beta agonist
(SABA) inhalations and an increase in weekly number of SABA-free
days. In addition, patients in the ProAir Digihaler group had a
higher number of discussions with physicians around adherence and
inhaler technique prompted by the objective data provided by ProAir
Digihaler versus patients who used SoC albuterol inhalers.
“Asthma remains one of the most common and challenging chronic
health conditions in adults and children, many of whom have
poorly-controlled disease leading to increased symptoms,
exacerbations and healthcare resource utilization. Asthma
management is complicated, and overuse and misuse of rescue
medications is a common problem that contributes to poor asthma
control,” said Flavia C.L. Hoyte, M.D., Associate Professor of
Allergy and Immunology at National Jewish Health in Denver,
Colorado, and University of Colorado Hospital, Aurora, Colorado.
“This study highlights the potential of a digital health tool to
support asthma management and physician-patient interactions and
discussions around inhaler technique and adherence, as recommended
by asthma guidelines.”
CONNECT1 was a 12-week, multicenter, open-label, randomized,
parallel group feasibility study to evaluate the role of the ProAir
Digihaler and the Digihaler System in 333 adults and children (aged
≥13) with uncontrolled asthma, defined by Asthma Control Test (ACT)
score of <19. Patients were randomized 1:1 to the ProAir
Digihaler or SoC albuterol inhaler. In the ProAir Digihaler group,
patients’ inhalation data, including inhalation quantity and
quality, were monitored once or more per week via a
physician-facing dashboard. The study’s primary endpoint was
clinically meaningful improvement in ACT score, defined as
achieving a total ACT score ≥20 or an increase of at least three
units from baseline at 12 weeks. A Bayesian statistical analysis,
adjusted for baseline ACT score and random site effect, was used to
understand the effectiveness of the ProAir Digihaler and system
with respect to this primary outcome. Participants in the Digihaler
System group were trained on the use of the Digital System,
including instructions on how to use both the inhaler and smart
device app.
Study Results1
Patients using the ProAir Digital System (n=167) had a higher
probability (85.3%) for clinically meaningful improvements in
asthma control versus those using SoC (non-digital) albuterol
inhalers (n=166) after three months of treatment. In addition,
well-controlled asthma (ACT score of ≥20) or an improvement in
asthma control (increase in ACT score by ≥3 units) was achieved at
Week 12 by 92/150 (61%) of participants in the Digihaler group,
compared with 89/163 (55%) in the SoC group.2
More physician-reported interactions due to poor inhaler
technique were seen in the Digihaler group compared with the SoC
group (52 vs 1, respectively). The Digihaler group also had fewer
overall interactions (i.e., office visits or telephone calls) that
had been planned during a prior visit versus the SoC group (54 vs
104, respectively). Overall, 85 interactions in the patients using
the Digihaler System were reported because of data observed due to
information observed from the Digihaler System dashboard; of these,
32 (37.6%) interactions were due to increased SABA use.
Participants using the Digihaler System had more discussions with
their HCP on inhaler technique and/or adherence than those
receiving SoC (107 vs 44 discussions, respectively).
An increase in weekly number of SABA-free days was observed over
12 weeks, from 3.4 at Week 1 to 4.6 at Week 12, among patients
using the ProAir Digihaler. A decrease in weekly average daily SABA
inhalations, from 9.1 at Week 1 to 6.3 at Week 12, was also
observed among those in the Digihaler System group.
The number of participants that experienced ≥1 adverse events
(AE) was similar across the two groups (28 in the ProAir Digihaler
group versus 26 in the SoC group). No AEs led to discontinuation or
were considered device-related.
The study had several limitations which could have impacted
results, including differences between sites regarding app
synchronization and dashboard monitoring, a lack of thresholds for
HCP action, the study’s short duration of three months, and the
fact that the study was conducted during the COVID pandemic.
“Digital health tools are an increasingly important option for
helping address unmet needs in asthma care,” said Manny Montalvo,
Senior Vice President, Head of Digital Health & Innovation at
Teva. “As shown in this study, a ‘smart’ digital health product
like the ProAir Digihaler System that provides sensor-connected,
fully integrated digital technology and objective data on inhaler
use can elicit more discussions between physicians and patients on
inhaler use and technique that can lead to greater adherence to
treatment and reduced risk of asthma exacerbations.”
Initial findings from CONNECT1 were presented recently at the
European Respiratory Society (ERS) International Congress 2022,
held September 4-6 in Barcelona, Spain. The study’s full results
will be presented at the American College of Allergy, Asthma &
Immunology (ACAAI) 2022 Annual Scientific Meeting, November 10-14
in Louisville, Kentucky.
About ProAir Digihaler
The Digihaler Inhalers are the first family of smart inhalers
that capture personal inhaler data and help inform patients’ asthma
treatment plan. ProAir Digihaler (albuterol sulfate) Inhalation
Powder is the first and only breath-actuated, digital short-acting
beta agonist (SABA) inhaler with built-in flow sensors that detect,
record and store objective data showing how often and how well
patients use their rescue inhaler, as measured by inspiratory flow.
Patients are able to view their data on the Digihaler app,
including inhaler use patterns over time, and can share it with a
healthcare provider to facilitate dialogue and personalize
treatment discussions.
ProAir Digihaler Indications and Usage
ProAir Digihaler (albuterol sulfate) Inhalation Powder is a
prescription medicine used in people ≥4 years of age for the
treatment or prevention of bronchospasm in people who have
reversible obstructive airway disease and for the prevention of
exercise-induced bronchospasm.
Important Safety Information About ProAir Digihaler
- Contraindications: ProAir Digihaler (albuterol sulfate)
Inhalation Powder is contraindicated in patients with
hypersensitivity to albuterol or patients with a severe
hypersensitivity to milk proteins. Rare cases of hypersensitivity
reactions, including urticaria, angioedema, and rash have been
reported after the use of albuterol sulfate. There have been
reports of anaphylactic reactions in patients using inhalation
therapies containing lactose
- Paradoxical Bronchospasm: ProAir Digihaler can produce
paradoxical bronchospasm that may be life-threatening. Discontinue
ProAir Digihaler and institute alternative therapy if paradoxical
bronchospasm occurs
- Deterioration of Asthma: Need for more doses of ProAir
Digihaler than usual may be a marker of acute or chronic
deterioration of asthma and requires reevaluation of treatment,
such as possible need for anti-inflammatory treatment, e.g.,
corticosteroids
- Use of Anti-Inflammatory Agents: ProAir Digihaler alone
may not be adequate to control asthma in many patients. Early
consideration should be given to adding anti-inflammatory agents,
e.g., corticosteroids
- Cardiovascular Effects: ProAir Digihaler, like other
beta-adrenergic agonists, can produce clinically significant
cardiovascular effects in some patients, as measured by heart rate,
blood pressure, and/or symptoms. If such effects occur, the drug
may need to be discontinued. ProAir Digihaler, like all
sympathomimetic amines, should be used with caution in patients
with cardiovascular disorders, especially coronary insufficiency,
cardiac arrhythmias, and hypertension
- Do Not Exceed Recommended Dose: Fatalities have been
reported in association with excessive use of inhaled
sympathomimetic drugs in patients with asthma
- Hypersensitivity Reactions including Anaphylaxis:
Immediate hypersensitivity reactions may occur after administration
of albuterol sulfate, as demonstrated by rare cases of urticaria,
angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal
edema. Hypersensitivity reactions including anaphylaxis,
angioedema, pruritus, and rash have been reported with the use of
therapies containing lactose, an inactive ingredient in ProAir
Digihaler
- Coexisting Conditions: ProAir Digihaler, like all
sympathomimetic amines, should be used with caution in patients
with convulsive disorders, hyperthyroidism, or diabetes mellitus;
and in patients who are unusually responsive to sympathomimetic
amines
- Hypokalemia: As with other beta-agonists, ProAir
Digihaler may produce significant hypokalemia in some patients. The
decrease is usually transient, not requiring supplementation
- Most common adverse reactions (≥1% and >placebo) are
back pain, pain, gastroenteritis viral, sinus headache, urinary
tract infection, nasopharyngitis, oropharyngeal pain and
vomiting
- Drug Interactions: Other short-acting sympathomimetic
bronchodilators should not be used concomitantly with ProAir
Digihaler
- Beta-Blockers: Beta-adrenergic-receptor blocking agents
not only block the pulmonary effect of beta-agonists, such as
ProAir Digihaler, but may produce severe bronchospasm in asthmatic
patients. Therefore, patients with asthma should not normally be
treated with beta-blockers
- Diuretics: Caution is advised in the coadministration of
beta-agonists with non-potassium sparing diuretics (such as loop or
thiazide diuretics). Consider monitoring potassium levels
- Digoxin: Carefully evaluate the serum digoxin levels in
patients who are currently receiving digoxin and ProAir
Digihaler
- Monoamine Oxidase Inhibitors or Tricyclic
Antidepressants: ProAir Digihaler should be administered with
extreme caution to patients being treated with these agents, or
within 2 weeks of discontinuation of these agents, because the
action of albuterol on the cardiovascular system may be
potentiated. Consider alternative therapy
Please read the full Prescribing Information.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has
been developing and producing medicines to improve people’s lives
for more than a century. We are a global leader in generic and
specialty medicines with a portfolio consisting of over 3,500
products in nearly every therapeutic area. Around 200 million
people around the world take a Teva medicine every day, and are
served by one of the largest and most complex supply chains in the
pharmaceutical industry. Along with our established presence in
generics, we have significant innovative research and operations
supporting our growing portfolio of specialty and biopharmaceutical
products. Learn more at www.tevapharm.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, which are based on management’s current beliefs and
expectations and are subject to substantial risks and
uncertainties, both known and unknown, that could cause our future
results, performance or achievements to differ significantly from
that expressed or implied by such forward-looking statements. You
can identify these forward-looking statements by the use of words
such as “should,” “expect,” “anticipate,” “estimate,” “target,”
“may,” “project,” “guidance,” “intend,” “plan,” “believe” and other
words and terms of similar meaning and expression in connection
with any discussion of future operating or financial performance.
Important factors that could cause or contribute to such
differences include risks relating to the development and
commercial success of our digihaler products family, including
ProAir Digihaler; our ability to successfully compete in the
marketplace, including our ability to develop and commercialize
biopharmaceutical products, competition for our specialty products,
including AUSTEDO®, AJOVY® and COPAXONE®; our ability to achieve
expected results from investments in our product pipeline, our
ability to develop and commercialize additional pharmaceutical
products, and the effectiveness of our patents and other measures
to protect our intellectual property rights; our substantial
indebtedness; our business and operations in general, including
uncertainty regarding the COVID-19 pandemic and the governmental
and societal responses thereto; our ability to successfully execute
and maintain the activities and efforts related to the measures we
have taken or may take in response to the COVID-19 pandemic and
associated costs therewith; costs and delays resulting from the
extensive pharmaceutical regulation to which we are subject or
delays in governmental processing time due to travel and work
restrictions caused by the COVID-19 pandemic; compliance,
regulatory and litigation matters, including failure to comply with
complex legal and regulatory environments; other financial and
economic risks; and other factors discussed in our Quarterly Report
on Form 10-Q for the second quarter of 2022 and in our Annual
Report on Form 10-K for the year ended December 31, 2021, including
in the section captioned “Risk Factors.” Forward-looking statements
speak only as of the date on which they are made, and we assume no
obligation to update or revise any forward-looking statements or
other information contained herein, whether as a result of new
information, future events or otherwise. You are cautioned not to
put undue reliance on these forward-looking statements.
_____________________________ 1 Hoyte FCL, Mosnaim GS, Rogers L,
Safioti G, Brown R, Li T, DePietro M, Reich M, Hill TD, Wechsler
ME, Effectiveness of a digital inhaler system for patients with
asthma: a 12-week, open-label, randomized study (CONNECT1), The
Journal of Allergy and Clinical Immunology: In Practice (2022),
doi: https://doi.org/10.1016/j.jaip.2022.08.023. 2 Modified
Intention-to-treat (mITT) population
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220907005312/en/
IR Contacts United States Ran Meir (267) 468-4072 Yael
Ashman 972 (3) 914-8262
PR Contacts United States Doris Yiu (973) 265-3752
Yonatan Beker (973) 917-0851
Teva Pharmaceutical Indu... (NYSE:TEVA)
Historical Stock Chart
Von Nov 2023 bis Dez 2023
Teva Pharmaceutical Indu... (NYSE:TEVA)
Historical Stock Chart
Von Dez 2022 bis Dez 2023