Teva to Present First Data Set from the CONNECT1 Clinical Trial on ProAir® Digihaler® (albuterol sulfate) Inhalation Powder at the European Respiratory Society (ERS) International Congress 2022
The study evaluated the effect of the ProAir Digihaler System on asthma control versus standard of care as measured by the Asthma Control Test, and explored use of the ProAir Digihaler System to help support patient-physician interactions for asthma management versus standard of care
TEL AVIV, Israel & PARSIPPANY, N.J.--(BUSINESS WIRE)-- Teva Pharmaceuticals USA, Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA),today announced that the first findings from the CONNECT clinical program on ProAir® Digihaler® (albuterol sulfate) inhalation powder with an integrated electronic module (eModule) will be presented at the European Respiratory Society (ERS) International Congress 2022, held September 4-6 in Barcelona, Spain.
The CONNECT1 trial was conducted to assess the role of the ProAir Digihaler System in the treatment of asthma. The ProAir Digihaler System is a digital health system that tracks reliever inhaler usage and inhalation quality as measured by inspiratory flow to aid in clinical decision-making. The Digihaler System is comprised of the ProAir digital inhaler, smart device application, Digital Health Platform cloud solution and dashboard to record and track usage.
CONNECT1, the first study in the CONNECT clinical program, is a 12-week, open-label, multicenter, randomized, parallel group study that evaluated the ProAir Digihaler System and its impact on asthma management compared to standard of care (SoC) in 333 patients with asthma. Participants in the SoC group were treated with their SoC albuterol reliever inhalers and did not use the Digihaler System throughout the study’s treatment period.
Initial findings from CONNECT1 will be presented at ERS via two posters. One poster presentation will explore the effectiveness of the ProAir Digihaler System on improving asthma control versus SoC in adult and pediatric (13 years of age and older) patients with suboptimal asthma control. A second poster presentation will examine the impact of the ProAir Digihaler System on patient-physician interactions as part of asthma management versus SoC.
“We are excited to showcase these data to provide important insights into the use of a digital tool and how data collected from the ProAir DigihalerSystem may help inform more personalized asthma management,” said Randall Brown, MD, Global Lead, Digital Health, Immunology and Respiratory Medical Affairs at Teva. “Our latest data at ERS will explore how the ProAir Digihaler System – the first and only breath-actuated, digital SABA inhaler with built-in flow sensors – could yield more informed interactions between patients and providers.”
This presentation can be accessed by registering for the meeting.
Teva-sponsored data to be presented includes:
Effectiveness of a Reliever-Based Digital System on Asthma Control
Session: Remote Monitoring and Self-Management of Respiratory Patients
Date/Time: Tuesday, September 6th, 8:30 AM – 9:30 AM
Data From a Reliever-Based Digital System Supports Patient-Clinician Interactions in Asthma
Session: Remote Monitoring and Self-Management of Respiratory Patients
Date/Time: Tuesday, September 6th, 8:30 AM – 9:30 AM
About ProAir Digihaler
The Digihaler Inhalers are the first family of smart inhalers with built-in sensors that capture personal inhaler data and allow patients to track and share their data. ProAirDigihaler (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 personalized data on the Digihaler app and can share it with a healthcare provider to inform their asthma treatment plan, facilitate dialogue and guide decisions around treatment adjustments. This personal inhaler data can record how well a patient uses their inhaler by measuring the strength of inhalations, indicating when inhaler technique may need improvement. In addition, the data can capture rescue inhaler user patterns over time and show trends indicating when increasing SABA use might be associated with disease worsening.
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 Dighaler 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.
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 portfolio 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.
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