Proair digihaler (albuterol sulfate) / Teva - LARVOL DELTA

DIGITAL INHALER-DERIVED INHALATION PARAMETERS PREDICT RISK OF ASTHMA EXACERBATION (CHEST 2025) - P4 | "In this real-world study, digital inhaler-derived changes in inhalation volume provide an early and robust signal for predicting imminent exacerbations in SA. CLINICAL IMPLICATIONS: Incorporating continuous inhalation-volume monitoring into routine SA care may facilitate early, individualized interventions."

Asthma • Immunology • Respiratory Diseases

Use of a digital rescue inhaler and at-home spirometer among inner-city children with asthma: a real-world experience. (PubMed, Front Allergy) - "In total, 21 pediatric patients with asthma (8-17 years of age) were asked to replace rescue medications with the ProAir Digihaler and perform at-home gamified spirometry daily...Younger children used the spirometer more frequently and demonstrated improvements in asthma control, severity, and quality of life. These improvements were not observed in older children."

Journal • Real-world evidence • Asthma • Immunology • Obesity • Pediatrics • Pulmonary Disease • Respiratory Diseases

Use of a Digital Inhaler to Assess COPD Disease Variability and Identify Impending Acute COPD Exacerbations: A Pilot Study. (PubMed, Chronic Obstr Pulm Dis) - "Participants used the ProAir Digihaler for primary rescue medication during the study...There were no significant changes observed in PIF (67.2 versus 63.3, p=0.1) and number of inhalations per day (2.7 versus 3.7, p=0.2). Physiologic data captured by a digital inhaler may serve as a valuable remote patient monitoring tool to help support the identification of early or impending AECOPDs among ambulatory COPD patients and monitor COPD disease variability."

Journal • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Predictive machine learning algorithm for COPD exacerbations using a digital inhaler with integrated sensors. (PubMed, BMJ Open Respir Res) - P3 | "We demonstrated the development of a proof-of-concept machine learning model predictive of impending COPD exacerbations using data from the integrated digital reliever inhaler. This approach may potentially support patient monitoring, help improve disease management, and enable pre-emptive interventions to minimise exacerbations."

Journal • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Teva Asthma Predictive Analytics Study (clinicaltrials.gov) - P4 | N=101 | Completed | Sponsor: University of Michigan | Trial primary completion date: Sep 2024 ➔ Dec 2023 | Active, not recruiting ➔ Completed | Trial completion date: Sep 2024 ➔ Dec 2023

Heterogeneity • Trial completion • Trial completion date • Trial primary completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

DATA FROM A DIGITAL INHALER COUPLED WITH EXPERT-CONSENSUS RELIEVER MEDICATION USE THRESHOLDS: A NOVEL WAY TO IDENTIFY IMPENDING OR ONGOING ASTHMA EXACERBATION (CHEST 2023) - P4 | "In this real-world study, the majority of patients who overused their reliever medication had at least one asthma exacerbation. These findings further demonstrate that data on medication use, accurately collected by a digital inhaler, can be used to help identify expert-defined overuse of reliever medications. CLINICAL IMPLICATIONS: Applying evidence-based expert consensus thresholds on reliever medication use, combined with patients’ digital reliever medication use data, can be a novel way to help identify impending asthma exacerbations in real-world clinical practice."

Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Teva Asthma Predictive Analytics Study (clinicaltrials.gov) - P4 | N=101 | Active, not recruiting | Sponsor: University of Michigan | Trial completion date: Jul 2023 ➔ Sep 2024 | Trial primary completion date: Jul 2023 ➔ Sep 2024

Heterogeneity • Trial completion date • Trial primary completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Phil and Teva Pharmaceuticals Launch New Program to Improve Access to the Digihaler Family of Inhalers to Support Asthma Management (Businesswire) - "Phil...today announced an agreement with Teva Pharmaceuticals that will make Digihaler® products available for prescription using the PhilRx Patient Access Platform....The goal of Phil and Teva Pharmaceuticals’ partnership is to help enable patients to receive and refill their Digihaler medication quickly, easily and affordably."

Licensing / partnership • Asthma • Respiratory Diseases

Objectively Recorded Peak Inspiratory Flow (PIF), Inhalation Volume and Reliever Medication Use Preceding COPD Exacerbations (ATS 2023) - P=N/A | "Use of an electronically enabled inhalation device capable of assessing inhalation frequency, flow and volume provides valuable data that may have utility in predicting an impending AECOPD and that could signal for early intervention. In addition, the sequence of changes among these variables may inform understanding of physiological processes underlying exacerbations, such as hyperinflation and respiratory muscle weakness, thereby potentially further enhancing their predictive value in the future."

Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Inhalation Parameter and Inhaler Usage Thresholds Preceding COPD Exacerbations in Patients Using the Albuterol Digihaler (ATS 2023) - "Patients (n=20; mean (range) age: 67 (57-78) years; 60% female) had GOLD Stage 2-3 COPD. 75% of the patients were classified as GOLD Group B according to COPD Assessment Test (CAT) score and exacerbation history. Eleven of the 20 patients experienced a total of 23 COPD exacerbations during the study."

Clinical • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

App-Based Symptom Assessment Is Triggered by Inhaler Use Changes Preceding COPD Exacerbations (ATS 2023) - P=N/A | "Changes in inhalation parameters and inhaler use occur in the days preceding an AECOPD, and can provide objective triggers for automated symptom assessment. This has the potential to improve symptom assessments by enhancing patient awareness about objective changes in rescue use and inhalation parameters at the time they are happening."

Chronic Obstructive Pulmonary Disease • Fatigue • Immunology • Pulmonary Disease • Respiratory Diseases

Inhalation Technique Maintenance in COPD Patients Using the Albuterol Digihaler (ATS 2023) - P=N/A | "Patients with COPD using the albuterol Digihaler rapidly demonstrated good inhaler technique which was maintained over the three-month study period. The Digihaler System is able to record objective inhalation quality data, permitting assessment of patient efforts and technique. Data from the Digihaler System communicated to providers via the physician-facing dashboard may aid in assessing whether poor technique or other factors underlie clinical deterioration."

Clinical • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Teva Asthma Predictive Analytics Study (clinicaltrials.gov) - P4 | N=101 | Active, not recruiting | Sponsor: University of Michigan | Recruiting ➔ Active, not recruiting

Enrollment closed • Heterogeneity • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Digihaler in Chronic Obstructive Pulmonary Disease (COPD) (clinicaltrials.gov) - P=N/A | N=55 | Completed | Sponsor: University of North Carolina, Chapel Hill | Active, not recruiting ➔ Completed | Phase classification: P1 ➔ PN/A

Phase classification • Trial completion • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Teva to Present New Data from CONNECT2 Study on its Digihaler System at the American Academy of Allergy, Asthma and Immunology (AAAAI) 2023 Annual Meeting (Businesswire) - "Teva Pharmaceuticals USA, Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd...announced that new data on its Digihaler System will be presented at the American Academy of Allergy, Asthma and Immunology (AAAAI) 2023 Annual Meeting, being held February 24-27 in San Antonio, Texas. The data includes findings from the CONNECT2 clinical trial program as well as information on patients and healthcare professionals' real-world use of the smart inhaler system. The Digihaler System is the first and only smart inhaler system with built-in sensors that provide objective inhaler event data to help patients and their doctors support asthma management and develop personalized treatment plans."

P4 data • Retrospective data • Asthma • Respiratory Diseases

Digihaler in Chronic Obstructive Pulmonary Disease (COPD) (clinicaltrials.gov) - P1 | N=55 | Active, not recruiting | Sponsor: University of North Carolina, Chapel Hill | Recruiting ➔ Active, not recruiting

Enrollment closed • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

A Predictive Machine Learning Tool for Asthma Exacerbations: Results from a 12-Week, Open-Label Study Using an Electronic Multi-Dose Dry Powder Inhaler with Integrated Sensors. (PubMed, J Asthma Allergy) - "Adult patients with poorly controlled asthma were enrolled in a 12-week, open-label study using ProAir Digihaler, an electronic multi-dose dry powder inhaler (eMDPI) with integrated sensors, as reliever medication (albuterol, 90 µg/dose; 1-2 inhalations every 4 hours, as needed)...A machine learning model to predict impending asthma exacerbations using data from the eMDPI was successfully developed. This approach may support a shift from reactive care to proactive, preventative, and personalized management of chronic respiratory diseases."

Journal • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Teva to Present Latest Research from the CONNECT1 and CONNECT2 Clinical Trials at the American College of Allergy, Asthma & Immunology (ACAAI) 2022 Annual Scientific Meeting (Businesswire) - "Teva Pharmaceuticals...today announced that new findings from the CONNECT clinical trial program assessing the use of the Digihaler System compared to standard of care (SoC) in asthma management will be presented at the American College of Allergy, Asthma & Immunology (ACAAI) 2022 Annual Scientific meeting, being held November 10-14 in Louisville, Kentucky. The data will be featured in six posters, three of which will highlight results from the CONNECT1 clinical trial evaluating the ProAir® Digihaler (albuterol sulfate) inhalation powder with a built-in electronic sensor in asthma management versus SoC. Three additional posters will share the first data from the CONNECT2 clinical trial assessing the joint use of the ProAir Digihaler and the AirDuo® Digihaler (fluticasone propionate and salmeterol) inhalation powder with a built-in sensor in asthma management versus SoC."

P4 data • Asthma • Respiratory Diseases

ProAir Digihaler in COPD Disease Management: A Real World Study (clinicaltrials.gov) - P=N/A | N=27 | Completed | Sponsor: Pulmonary Research Institute of Southeast Michigan | Active, not recruiting ➔ Completed

Real-world evidence • Trial completion • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Application of Modified Delphi Expert Consensus Thresholds on SABA Reliever Use in Asthma to Data Obtained from a 12-Week Study of a Digital Inhaler in Suboptimally Controlled Asthma Patients (ATS 2022) - P3 | " Previously, patients with ≥1 asthma exacerbation/prior year and suboptimal asthma control (ACQ ≥1.5) used ProAir Digihaler for 12 weeks in an open-label study (NCT02969408)... These findings reflect a novel application of expert consensus thresholds to an asthma patient cohort whose day-to-day SABA reliever use was reliably recorded via digital means. They suggest that elevated SABA reliever use among suboptimally controlled asthma patients - including at levels agreed by experts to be associated with exacerbations and asthma-related death - may be far more commonplace than previously understood. The advent of digital inhalers offers new potential to address this challenge and develop individualized preventive approaches informed by reliable reliever usage data."

Clinical • Late-breaking abstract • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Teva to Present Findings on Short-Acting Beta Agonist (SABA) Use in Asthma Patients and the Potential of ProAir Digihaler (albuterol sulfate) Inhalation Powder to Help Inform Treatment Decisions at American Thoracic Society 2022 Annual Meeting (Businesswire) - "Teva Pharmaceuticals...today announced new findings will be presented at the 2022 American Thoracic Society (ATS) 2022 Annual Meeting that apply clinical thresholds for short-acting beta agonist (SABA) use established by independent expert consensus to objective patient data from ProAir Digihaler (albuterol sulfate) Inhalation Powder. These findings are the first to examine daily SABA usage captured by the ProAir Digihaler based on the clinical thresholds and will be presented in a late-breaker oral session at the 2022 ATS Annual Meeting, taking place on May 13-18, 2022, in San Francisco."

Clinical data • Late-breaking abstract • Asthma • Chronic Obstructive Pulmonary Disease • Respiratory Diseases

ProAir Digihaler in COPD Disease Management: A Real World Study (clinicaltrials.gov) - P=N/A | N=27 | Active, not recruiting | Sponsor: Pulmonary Research Institute of Southeast Michigan | Trial completion date: Mar 2022 ➔ Jun 2022 | Trial primary completion date: Mar 2022 ➔ Jun 2022

Real-world evidence • Trial completion date • Trial primary completion date • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Digihaler in Chronic Obstructive Pulmonary Disease (COPD) (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: University of North Carolina, Chapel Hill

New P1 trial • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

ProAir Digihaler in COPD Disease Management: A Real World Study (clinicaltrials.gov) - P=N/A; N=27; Active, not recruiting; Sponsor: Pulmonary Research Institute of Southeast Michigan; Recruiting ➔ Active, not recruiting; N=20 ➔ 27

Clinical • Enrollment change • Enrollment closed • Real-world evidence • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

[VIRTUAL] SABA use increase weeks before asthma exacerbations recorded via a digital inhaler (ERS 2021) - "Conclusions Data from ProAir Digihaler show increased SABA use up to 30 days before an exacerbation. This early signalling may suggest disease deterioration, and potentially allow for pre-emptive, more effective personalised asthma management."

Asthma • Immunology • Pulmonary Disease • Respiratory Diseases