Journal of Aerosol Medicine and Pulmonary Drug Delivery最新文献

{"title":"Prospects of Inhalable Formulations of Conventionally Administered Repurposed Drugs for Adjunctive Treatment of Drug-Resistant Tuberculosis: Supporting Evidence from Clinical Trials and Cohort Studies.","authors":"Rajeev Ranjan, Venkata Siva Reddy Devireddy","doi":"10.1089/jamp.2024.0051","DOIUrl":"10.1089/jamp.2024.0051","url":null,"abstract":"<p><p><b><i>Background:</i></b> Drug resistant tuberculosis is a major public health concern, since the causative agent Mycobacterium tuberculosis is resistant to the most effective drugs against tuberculosis treatment ie., rifampicin and isoniazid. Globally, it accounts 4.6 percent of the patients with tuberculosis, but in some low socioeconomic areas this proportion exceeds to 25 percent. The treatment of drug resistant tuberculosis is prolonged (9-12 months) and often have less favorable outcome with novel as well as recently repurposed drugs administered by conventional routes. <b><i>Materials and Methods:</i></b> Clinically, these repurposed drugs have shown several major concerns including low penetration of the drugs to the pulmonary region, emergence of resistant forms, first pass effects, drug-drug interactions, food effects, and serious side effects upon administration by conventional route of administration. Although, several antimicrobial agents have been either approved or are under investigation at different stages of clinical trials and in pre-clinical studies via inhalation route for the treatment of respiratory infections, inhalable formulation for the treatment of drug resistant tuberculosis is most untouched aspect of drug delivery to validate clinically. Only a single dry powder inhalation formulation of capreomycin is able to reach the milestone, ie., phase I for the treatment of drug resistant tuberculosis. <b><i>Results:</i></b> Administering inhalable formulations of repurposed drugs as adjuvant in the treatment of drug resistant tuberculosis could mitigate several concerns by targeting drugs directly in the vicinity of bacilli. <b><i>Conclusion:</i></b> This review focuses on the limitations and major concerns observed during clinical trials of repurposed drugs (host directed or bactericidal drugs) administered conventionally for the treatment of drug resistant tuberculosis. The outcomes and the concerns of these clinical trials rationalized the need of repurposing formulation which could be administered by inhalation route as adjunctive treatment of drug resistant tuberculosis.</p>","PeriodicalId":14940,"journal":{"name":"Journal of Aerosol Medicine and Pulmonary Drug Delivery","volume":" ","pages":"149-167"},"PeriodicalIF":1.8,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12419446/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142794562","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Preclinical Testing of a New Dry Powder Aerosol Synthetic Lung Surfactant Formulation and Device Combination for the Treatment of Neonatal Respiratory Distress Syndrome.","authors":"Worth Longest, Michael Hindle, Dale Farkas, Mohammad A M Momin, Caleb Dalton, Felicia Hall, Ghali Aladwani, Hattie KenKnight, Robert M DiBlasi","doi":"10.1089/jamp.2025.0001","DOIUrl":"10.1089/jamp.2025.0001","url":null,"abstract":"<p><p><b><i>Background:</i></b> This study advanced the preclinical development of a new dry powder aerosol synthetic lung surfactant (SLS) product for neonatal respiratory distress syndrome (RDS) by integrating a multiple-actuation device and scalable spray-dried formulation, evaluating physicochemical and <i>in vitro</i> aerosol performance, and then comparing biological efficacy with the current clinical standard of high-volume liquid bolus instillation. <b><i>Methods:</i></b> A new high-dose air-jet dry powder inhaler was developed that was characterized by a variable-volume aerosolization chamber (D3 device) with the goal of unifying aerosol quality and emitted dose (ED) over multiple actuations. The SLS excipient enhanced growth dry powder formulation was advanced through production on a scalable nozzle-based spray dryer system (Mini Spray Dryer; MSD2 formulation). Physicochemical characterization of the formulation was performed along with <i>in vitro</i> aerosol testing of the new D3-MSD2 device and formulation combination. The optimized D3-MSD2 aerosol therapy was then evaluated in a rabbit model of severe RDS. <b><i>Results:</i></b> The new D3-MSD2 combination produced a small-particle aerosol with high fine particle fraction (FPF_{<5 µm} = 87.9%; FPF_{<2.5 µm} = 61.6%) and percent ED (77.4% of loaded). Additional <i>in vitro</i> testing highlighted consistent particle size (D_v50 = 1.6 µm) and ED across multiple actuations. In the animal model experiments, a total device-loaded formulation mass of 60 mg (delivered as 2x30 mg) produced a total phospholipid (PL) dose of 24 mg-PL/kg and a device ED of 18 mg-PL/kg compared with the 200 mg-PL/kg clinical dose of Curosurf liquid. <i>In vivo</i> response rate for the D3-MSD2 aerosol therapy was considerably more rapid with arterial oxygenation recovering 5-12 times faster than for liquid Curosurf. Biological response for the D3-MSD2 aerosol therapy was also superior with 2-fold improvement in final lung compliance compared with liquid Curosurf. <b><i>Conclusions:</i></b> The new D3-MSD2 aerosol therapy was found to be superior to clinical-practice liquid bolus instillation in the critical areas of required dose (order-of-magnitude reduction), delivery time, biological response rate, and efficacy.</p>","PeriodicalId":14940,"journal":{"name":"Journal of Aerosol Medicine and Pulmonary Drug Delivery","volume":" ","pages":"168-191"},"PeriodicalIF":1.8,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12433280/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143965555","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Lung Deposition of Extrafine Versus Nonextrafine Aerosols at Low Inhalation Flow Rates in Adult Asthma Patients: A Composition Study.","authors":"Maciej Kupczyk, Michał Panek, Hosein Sadafi, Wilfried De Backer, Maciej Wojakiewicz, Tomasz Dębowski","doi":"10.1089/jamp.2024.0052","DOIUrl":"10.1089/jamp.2024.0052","url":null,"abstract":"<p><p><b><i>Backgroud:</i></b> A key attribute in selecting an oral inhaler device for chronic obstructive pulmonary disease (COPD) and asthma is its ability to dispense a high degree of pulmonary deposition of the drug at low inspiratory flows. <b><i>Methods:</i></b> In this study, the lung deposition of extrafine formulations of beclomethasone dipropionate (BDP) and formoterol fumarate (FF) (pressurized metered-dose inhaler [pMDI] and dry powder inhaler [DPI], NEXThaler) was compared with that of nonextrafine formulations of fluticasone/salmeterol (FP/SAL) Diskus DPI and budesonide/formoterol (BUD/FF) Turbuhaler DPI in 10 patients. Diskus intrathoracic (peripheral and central) lung deposition was estimated at low inhalation flow rates (30 and 40 L/min) <i>via</i> validated functional respiratory imaging (FRI) and computational fluid dynamics (CFD) methods. <b><i>Results:</i></b> The BDP/FF NEXThaler and BDP/FF pMDI had the highest median percentages of intrathoracic deposition, with consistent mean values of approximately 50% and 40%, respectively. The median percentage of peripheral deposition from extrafine inhalers was above 30% with BDP/FF NEXThaler and pMDI, 5% or less with the FP/SAL Diskus at both flow rates, and ranged between 12% and 22% with the BUD/FF Turbuhaler DPI at flow rates of 30 and 40 L/min, respectively. <b><i>Conclusions:</i></b> Extrafine BDP/FF using NEXThaler and pMDI resulted in greater peripheral deposition of both the inhaled corticosteroid and long-acting beta-agonists moieties than the nonextrafine FP/SAL Discus and BUD/FF DPIs did.</p>","PeriodicalId":14940,"journal":{"name":"Journal of Aerosol Medicine and Pulmonary Drug Delivery","volume":" ","pages":"202-210"},"PeriodicalIF":1.8,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12433279/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143991262","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Association of Inhaled Corticosteroid Use with COVID-19 Severity and Hospitalization in Patients With and Without Respiratory Disease.","authors":"Michal Leibovitch, Bernice Oberman, Jacob Cohen, Tamar Strahl, Noga Yosef, Yael Reichenberg, Dekel Shlomi","doi":"10.1089/jamp.2025.0004","DOIUrl":"10.1089/jamp.2025.0004","url":null,"abstract":"<p><p><b><i>Background:</i></b> Several studies have demonstrated the benefit of inhaled corticosteroids (ICS) before COVID-19 illness in reducing hospitalization time and reducing viral entrance to lung cells. This study explores the risk of severe COVID-19 illness among patients who had purchased ICS. <b><i>Methods:</i></b> In a retrospective study, adult patients with COVID-19 before the emergence of the Omicron variant were included. The severity, hospitalization rates, and mortality due to COVID-19 among patients who purchased and did not purchase ICS during the 6 months before the illness were compared. <b><i>Results:</i></b> Of the 44,866 COVID-19 patients, 2359 (5.3%) were hospitalized. Information regarding the severity of hospitalization was available for 2259 patients. Of these, 602 (27%) were classified as having severe disease and 510 (22%) died. Patients with higher socioeconomic status (SES) had less hospitalization rates but significantly higher risk for severe COVID-19 and a higher mortality rate. In a multivariate analysis, a significantly higher risk for hospitalization was found only for patients who purchased ICS when no respiratory disease was recorded (odds ratio 1.53,95% confidence interval: 1.15-2.01), relative to those who did not purchase ICS. <b><i>Conclusions:</i></b> Patients with unrecorded respiratory disease who purchased ICS are at higher risk for hospitalization due to COVID-19; therefore, rigorous attempts should be made to better characterize their illness. Higher SES was associated with more severe COVID-19 and higher mortality rates and these patients should have early hospitalization.</p>","PeriodicalId":14940,"journal":{"name":"Journal of Aerosol Medicine and Pulmonary Drug Delivery","volume":" ","pages":"192-201"},"PeriodicalIF":1.8,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12433278/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144017721","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Spacers and Valved Holding Chambers.","authors":"Sunalene Devadason","doi":"10.1089/jamp.2025.87987.sd","DOIUrl":"10.1089/jamp.2025.87987.sd","url":null,"abstract":"<p><p>Spacers, primarily valved holding chambers (VHCs), are widely used to overcome some of the problems associated with the use of pressurized metered-dose inhalers (pMDIs). These include the difficulty experienced by patients in trying to coordinate the initiation of inhalation with the actuation of the pMDI. High oropharyngeal deposition of drug, which may result in both local and systemic side effects, is also a problem. Although the variability in output from pMDIs under optimized conditions in the laboratory is low, the variability when used in clinical practice is likely to increase considerably. Hence, the dose introduced into a holding chamber may vary significantly depending on the way in which the pMDI canister is handled before it is actuated. Several studies have shown that various design factors can influence the dose delivered from a holding chamber. These include spacer volume, shape, valve design, using multiple actuations, delay between actuation and inhalation, and construction material, which affects the level of electrostatic charge accumulating on the spacer surfaces. Several spacers which are made from low or anti-static materials are now available. Recommendations for optimal use of spacers, including inhalation techniques are outlined in this chapter, and vary according to patient age and inhalation coordination capability. Efficiency of drug delivery and lung deposition are also dependent on pMDI drug formulation and the patient's anatomical and physiological characteristics.</p>","PeriodicalId":14940,"journal":{"name":"Journal of Aerosol Medicine and Pulmonary Drug Delivery","volume":"38 4","pages":"211-215"},"PeriodicalIF":1.8,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12435187/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144794514","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparative Efficacy of Two Inhalational Techniques when Using a Pressurized Meter Dose Inhaler with Valved Holding Chamber in Children with Asthma: A Randomized Controlled Trial.","authors":"Rashmi Ranjan Das, Amit Kumar Satapathy, Manoj Kumar Panigrahi","doi":"10.1177/19412711251360981","DOIUrl":"https://doi.org/10.1177/19412711251360981","url":null,"abstract":"<p><p><b><i>Introduction:</i></b> Inhaled medication delivered through a pressurized metered dose inhaler (pMDI) with a valved holding chamber (VHC) is the optimal treatment for asthma. The best technique is the breath-holding (BH) technique. Tidal breathing (TB) technique is also recommended by Global Initiative for Asthma (GINA) as an alternative. Clinical studies have shown variable results, but the scintigraphy study shows better lung deposition with the BH technique. The present study was designed to address the shortcomings in previous studies and to confirm the scintigraphy study findings by comparing the two techniques. <b><i>Methods:</i></b> This randomized controlled trial included children aged 5-14 years with nonsevere asthma not taking inhaled medications on entry to the study, but during the study, they were given inhaled medications by pMDI + VHC (according to GINA guidelines) over an 8-week period. Demography, clinical details, spirometry parameters, and asthma control were recorded/assessed. The primary outcome was change in spirometry parameters at 2 and 8 weeks. <b><i>Results:</i></b> Eighty-two children (mean age: 8.64 years, 46 boys) were included. There was no intergroup difference in the spirometry parameters and asthma control scores at any point in time (<i>p</i> > 0.05). A significant intragroup improvement was noted only for forced expiratory volume in the first second at 8 weeks (<i>p</i> < 0.05). Similarly, a significant intragroup improvement in asthma control score was noted at 8 weeks (<i>p</i> < 0.05). No adverse event was noted in either of the groups. <b><i>Conclusions:</i></b> The present study found no difference between the BH and the TB techniques while delivering aerosols through a pMDI with a VHC. Either the BH or the TB technique may be used in children (5-14 years) with nonsevere asthma. <b><i>Clinical trial registration number:</i></b> CTRI/2020/12/030078.</p>","PeriodicalId":14940,"journal":{"name":"Journal of Aerosol Medicine and Pulmonary Drug Delivery","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2025-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144636998","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"<i>Letter:</i> Comment on \"Association of Inhaled Corticosteroid Use with COVID-19 Severity and Hospitalization in Patients with and Without Respiratory Disease\".","authors":"Hinpetch Daungsupawong, Viroj Wiwanitkit","doi":"10.1177/19412711251360630","DOIUrl":"https://doi.org/10.1177/19412711251360630","url":null,"abstract":"","PeriodicalId":14940,"journal":{"name":"Journal of Aerosol Medicine and Pulmonary Drug Delivery","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2025-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144626396","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"<i>In Silico</i> Modeling of Resistances and Dosimetry in Sarcoidosis Patients with Airway Disease.","authors":"Matthew J Eden, Narges Mirdamadi, Daniel VanDerhoef, David M Perlman, Maneesh Bhargava, Jessica M Oakes","doi":"10.1089/jamp.2024.0004","DOIUrl":"10.1089/jamp.2024.0004","url":null,"abstract":"<p><p><b><i>Background:</i></b> Sarcoidosis is a multisystem granulomatous disease that often impacts the lungs with mucosal inflammation, cobblestoning of the central airways, obstruction, and small airway disease. Airway involvement is often under-reported and not well understood, despite likely having implications for the work of breathing and particle dosimetry. <b><i>Methods:</i></b> To shed light on sarcoidosis disease with airway involvement, we performed patient-specific computational fluid dynamics and particle transport simulations in three subjects, for a few generations of the large conducting airways, with various presentations of airway disease. While Patient A had peripheral obstruction as identified from pulmonary function tests (PFTs), airway models created from computed tomography (CT) scans highlighted lower left lobe central airway abnormalities. Patient B presented with airway obstruction and diffusive stenosis throughout all five lobes while Patient C had normal PFTs and CT scans. <b><i>Results:</i></b> Localized central airway remodeling in Patient A resulted in localized elevation in dosimetry but no changes in total dosimetry or airway resistances, as also seen in Patient C. The subject with diffusive remodeling had abnormally high airway resistances and central airway deposition within the 3D-modeled airways. <b><i>Conclusions:</i></b> Results from this pilot study suggest that patients with diffuse remodeling may have enhanced susceptibility to environmental pollutants due to increased aerosol dosimetry. For aerosol medication treatment, the subject with diffusive airway remodeling may not receive adequate therapeutic dose if the goal is to deliver medication to the lung periphery. This study provides the first glimpse of airflow, resistances, and particle dosimetry in sarcoidosis subjects. Future studies should focus on phenotyping airway abnormalities in a larger sarcoidosis cohort and performing whole lung dosimetry modeling.</p>","PeriodicalId":14940,"journal":{"name":"Journal of Aerosol Medicine and Pulmonary Drug Delivery","volume":" ","pages":""},"PeriodicalIF":1.8,"publicationDate":"2025-07-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144618105","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Aerosol Delivery to an Adult Model via High-Flow Nasal Cannula with Inspiration-Synchronized Small-Particle Vibrating Mesh Nebulizer.","authors":"Jie Li, Osama Alanazi, James B Fink","doi":"10.1089/jamp.2025.0005","DOIUrl":"https://doi.org/10.1089/jamp.2025.0005","url":null,"abstract":"<p><p><b><i>Background:</i></b> Aerosol delivery via high-flow nasal cannula (HFNC) with an inspiration-synchronized vibrating mesh nebulizer (VMN) yielded higher inhaled doses than with a continuous VMN. Recently, a prototype VMN generating aerosol particles <3 µm improved aerosol delivery during invasive ventilation in adult and pediatric models, outperforming the conventional VMN. However, the effects of inspiration-synchronized small-particle VMN during HFNC remain unknown. <b><i>Methods:</i></b> An adult manikin was connected to a dual-chamber lung model driven by a ventilator to simulate spontaneous breathing. An HFNC system was utilized with gas flows at 15, 30, and 60 L/min with temperature at 37°C. Both small-particle and conventional VMNs were tested in inspiration-synchronized and continuous modes, with placements at the humidifier inlet and near the nasal cannula. Each experiment involved delivering 1 mL of albuterol (2.5 mg/mL) and was repeated five times. A collecting filter placed at the trachea captured aerosol, which was then eluted and assayed with UV spectrophotometry (276 nm). <b><i>Results:</i></b> When VMN was placed near the nasal cannula, inspiration-synchronized VMN consistently delivered greater inhaled doses compared with continuous VMN, regardless of aerosol particle sizes or HFNC flows (all <i>p</i> < 0.05). When positioned at the humidifier inlet, continuous VMN yielded higher inhaled doses than inspiration-synchronized VMN at 30 and 60 L/min but lower inhaled doses at 15 L/min (all <i>p</i> < 0.05). In the inspiration-synchronized mode, the small-particle VMN delivered greater inhaled doses at HFNC flows of 15 and 30 L/min than the conventional VMN, independent of nebulizer placements (all <i>p</i> < 0.05). The highest inhaled dose was observed with the inspiration-synchronized VMN placed near the nasal cannula and the continuous VMN placed at the humidifier inlet. <b><i>Conclusions:</i></b> In a model of adult transnasal aerosol delivery, the inspiration-synchronized VMN delivered a higher inhaled dose than the continuous VMN when placed near the nasal cannula. The small-particle VMN offers potential for further improvement in aerosol delivery.</p>","PeriodicalId":14940,"journal":{"name":"Journal of Aerosol Medicine and Pulmonary Drug Delivery","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2025-07-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144560199","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Inhaled Volume as a Digital Biomarker Predicting Outcomes in Chronic Respiratory Disease.","authors":"Henry Chrystyn, Mark Milton-Edwards","doi":"10.1089/jamp.2024.0063","DOIUrl":"https://doi.org/10.1089/jamp.2024.0063","url":null,"abstract":"<p><p>Inhaler-based digital biomarkers can be objectively evaluated to indicate changes in response to therapeutic interventions. In chronic respiratory disease (CRD), measures of exhaled airflow play a central role in diagnosis and management, yet inhaled measures have not. Digital inhalers can passively collect inspiratory parameters such as inhaled volume (InhV) and peak inspiratory flow (PIF) during real-life patient use. Emphasis has been directed to the PIF, but little is known about the role of the InhV. InhV has now been observed to decrease prior to an exacerbation of asthma or chronic obstructive pulmonary disease and increase afterwards and be lower in uncontrolled asthma patients. These observations are consistent with the current understanding of the pathophysiology of CRD, whereby a strong correlation between InhV and forced expiratory volume in one second has been observed. Measurement of InhV has demonstrated accuracy and low variability, supporting the validity of interpreting individualized trends over time. After counseling, patient inhalation technique decays over time, and it is InhV that decreases more than PIF. Together, these findings suggest that InhV, captured by a digital inhaler, has utility as an effective digital biomarker to aid management of patients with CRD, with InhV being a major factor in the predictive value with respect to acute exacerbations.</p>","PeriodicalId":14940,"journal":{"name":"Journal of Aerosol Medicine and Pulmonary Drug Delivery","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2025-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144553641","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}