Real-life inhaler technique in asthma patients using the electronic ProAir Digihaler

Chrystyn, Henry; Safioti, Guilherme; Buck, Dan; Granovsky, Lena; Calderon, Enric; Li, Thomas; Reich, Michael; Hill, Tanisha; DePietro, Michael; Pleasants, Roy A.

doi:10.1183/13993003.congress-2019.pa4258

Cited by 7 publications

(4 citation statements)

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“…52 It is now possible to measure a patient's inspiratory flow during each use of an inhaler using sensors integrated into the device, allowing the identification and correction of problems with inhaler technique in real time. 53 Multiple dry powder medications in different devices (eg, ) are approved for the treatment of COPD and to reduce the risk during an exacerbation. 7 However, if a patient is unable to inhale completely the medication from the DPI because of a suboptimal PIFr, then the therapy is unlikely to be effective.…”

Section: Discussionmentioning

confidence: 99%

Peak Inspiratory Flow as a Predictive Therapeutic Biomarker in COPD

Mahler

Halpin

2021

Chest

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Biomarkers in COPD may be clinical (prior exacerbation history), physiologic (FEV 1 ), or blood based (eosinophil count or fibrinogen level). Recent interest in using biomarkers to predict response to therapy in clinical practice has emerged. The benefits of inhaled therapy depend on the correct use of the inhaler, including an appropriate inspiratory flow. Of the available delivery systems, dry powder inhalers are unique because they have an internal resistance, are breath actuated, and are flow dependent. Ideally, the user inhales "forcefully" to generate turbulent energy (determined by an individual's inspiratory flow and the resistance of the device) within the device that disaggregates the powder so that the individual inhales the medication particles into the lower respiratory tract. Because of specific features of dry powder inhalers and the required optimal inspiratory flow, an unmet need exists to identify individuals who are likely or unlikely to benefit from dry powder medications. Peak inspiratory flow, defined as the maximum airflow generated during inhalation against the simulated resistance of a dry powder inhaler, is a physiologic measure that has biological plausibility, has good test characteristics (repeatability and reliability), and is generalizable.Current evidence supports peak inspiratory flow as a predictive therapeutic biomarker to optimize therapy in both outpatients with COPD as well as those hospitalized for an exacerbation before discharge. This approach is consistent with the precepts of precision medicine, which considers differences in a person's biological features, exposure, and lifestyle to prevent and treat disease.

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Section: Discussionmentioning

confidence: 99%

Peak Inspiratory Flow as a Predictive Therapeutic Biomarker in COPD

Mahler

Halpin

2021

Chest

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“…Currently FDA-approved DTx products have been clinically evaluated through RCTs, similarly to the process for drug products. The clinical trial designs for the selected FDAapproved DTx products on the market that have sufficient clinical trial information as of 2020 [1,2] are summarized in Table 2 [13][14][15][16][17][18][19][20][21][22]. All the clinical trials analyzed herein adopted a randomized, parallel group design.…”

Section: Clinical Evaluation Of Dtx Throughmentioning

confidence: 99%

Clinical Evaluation of Digital Therapeutics: Present and Future

Huh

Lee

et al. 2022

Healthc Inform Res

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Objectives: Digital therapeutics (DTx) are software-based therapeutic interventions based on clinical evidence. Randomized clinical trials (RCTs) are often the source of clinical evidence, similar to conventional drugs or medical devices. However, novel approaches such as the use of real-world data or digital biomarkers are also utilized. This article aimed to review how DTx products have been clinically evaluated. Methods: DTx products approved by the US Food and Drug Administration as of 2020 were reviewed and products with sufficient published information were selected. Pivotal clinical trials were analyzed according to the elements of the Consolidated Standards of Reporting Trials (CONSORT) guideline. Case reviews were presented for other clinical evaluation strategies, considering the small number of publications. Results: Most approved DTx products used RCTs for clinical evaluations. Similar to conventional RCTs, parallel-group designs with statistical hypothesis testing were adopted. However, DTx trials were often not blinded due to practical issues and involved various comparator groups. In addition, DTx products could be readily evaluated in home-based settings and delivered through the internet. Other evaluation approaches included retrospective analyses using insurance claims data or usage data, which enabled long-term evaluations of effectiveness. Digital biomarkers obtained from real-time and continuous log data were also used to improve the objectiveness of endpoints. Conclusions: RCTs accounted for the majority of DTx evaluations. The designs of DTx trials were comparable to those of drug or device trials, but blinding and comparator elements were often different. Furthermore, the use of real-world data and digital biomarkers are also being tried.

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“…The Digihaler ® contains an integrated digital sensor encompassed in an electronic module (eModule) on the top portion of the inhaler that can record usage (date and time), inhalation data relevant to the inhalation technique (e.g., PIF and flow volume), and provide medication reminders [109,118]. The accuracy, benefits, and outcomes of such digital DPIs, such as the Digihaler ® , are beginning to emerge [110,119,120]. Other FDA-approved digital DPIs included add-on sensors rather than being fully integrated in the DPI device.…”

Section: Advancements In Dpi Device Technologiesmentioning

confidence: 99%

Advancements in the Design and Development of Dry Powder Inhalers and Potential Implications for Generic Development

et al. 2022

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Dry powder inhalers (DPIs) are drug–device combination products where the complexity of the formulation, its interaction with the device, and input from users play important roles in the drug delivery. As the landscape of DPI products advances with new powder formulations and novel device designs, understanding how these advancements impact performance can aid in developing generics that are therapeutically equivalent to the reference listed drug (RLD) products. This review details the current understanding of the formulation and device related principles driving DPI performance, past and present research efforts to characterize these performance factors, and the implications that advances in formulation and device design may present for evaluating bioequivalence (BE) for generic development.

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Real-life inhaler technique in asthma patients using the electronic ProAir Digihaler

Cited by 7 publications

References 0 publications

Peak Inspiratory Flow as a Predictive Therapeutic Biomarker in COPD

Peak Inspiratory Flow as a Predictive Therapeutic Biomarker in COPD

Clinical Evaluation of Digital Therapeutics: Present and Future

Advancements in the Design and Development of Dry Powder Inhalers and Potential Implications for Generic Development

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