Publications by authors named "Michael DePietro"

Electronic inhalers provide information about patterns of routine inhaler use. During a 12-week study, 360 asthma patients using albuterol Digihaler generated 53,083 inhaler events that were retrospectively analyzed. A total of 41,528 (78%) of the recorded inhalation events were suitable for flow analysis (having a PIF ≥ 18 L/min and <120 L/min).

View Article and Find Full Text PDF

Background: Digital health tools have been shown to help address challenges in asthma control, including inhaler technique, treatment adherence, and short-acting β-agonist overuse. The maintenance and reliever Digihaler System (DS) comprises 2 Digihaler inhalers (fluticasone propionate/salmeterol and albuterol) with an associated patient App and web-based Dashboard. Clinicians can review patients' inhaler use and Digihaler inhalation parameter data to support clinical decision-making.

View Article and Find Full Text PDF

Purpose: Machine learning models informed by sensor data inputs have the potential to provide individualized predictions of asthma deterioration. This study aimed to determine if data from an integrated digital inhaler could be used to develop a machine learning model capable of predicting impending exacerbations.

Patients And Methods: 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).

View Article and Find Full Text PDF

Background: The albuterol Digihaler (albuterol 90 μg/dose) transmits data wirelessly to a smart device application, which synchronizes with a Digital Health Platform to store and transfer data to a web-based Dashboard. The Reliever Digihaler System (RDS) comprises the albuterol Digihaler, application, Digital Health Platform and Dashboard. This allows patients and health care professionals to review reliever inhaler usage and inhalation quality to aid clinical decision making.

View Article and Find Full Text PDF

Background: A variety of digital intervention approaches have been investigated for asthma therapy during the past decade, with different levels of interactivity and personalization and a range of impacts on different outcome measurements.

Objective: To assess the effectiveness of digital interventions in asthma with regard to acceptability and outcomes and evaluate the potential of digital initiatives for monitoring or treating patients with asthma.

Methods: We evaluated digital interventions using a scoping review methodology through a literature search and review.

View Article and Find Full Text PDF

Background: Reslizumab, an anti-IL-5 monoclonal antibody, is indicated as add-on maintenance treatment for adults with severe eosinophilic asthma.

Research Question: What are the real-world outcomes associated with reslizumab use in patients with severe eosinophilic asthma in a US clinical practice?

Study Design And Methods: In this retrospective study, patient-level data from adults treated with reslizumab were obtained from center- and panel-based medical chart reviews. Eligible patients had available medical records and treatment history for ≥ 6 months before initiation of reslizumab treatment (index date) to ≥ 7 months after reslizumab initiation.

View Article and Find Full Text PDF

Background: Attainment of asthma-specific US Healthcare Effectiveness Data and Information Set (HEDIS) quality measures may be associated with improved clinical outcomes and reduced economic burden.

Objective: We examined the relationship between the attainment of HEDIS measures asthma medication ratio (AMR) and medication management for people with asthma (MMA) on clinical and economic outcomes.

Methods: This retrospective claims database analysis linked to ambulatory electronic medical records enrolled US patients aged ≥5 years with persistent asthma between May 2015 and April 2017.

View Article and Find Full Text PDF

Background: Studies suggest that acute decreases in lung hyperinflation at rest improves cardiac function and increases lung vascular perfusion from decompression of a compromised heart. In those studies, changes in resting oxygen uptake induced by medications, an alternative explanation for compensatory increased cardiac function, were not explored.

Methods: This double-blind, multicenter, double-crossover study enrolled adults with chronic obstructive pulmonary disease, resting hyperinflation, and > 10% improvement in inspiratory capacity after 2 inhalations of budesonide/formoterol 160/4.

View Article and Find Full Text PDF

This study compared real-world patient-reported outcomes (PROs) measured by the Clinical COPD Questionnaire (CCQ), the London Chest Activities of Daily Living (LCADL) scale, and the Work Productivity and Activity Impairment (WPAI) questionnaire between individuals with COPD initiating LAMA/LABA fixed-dose combination (FDC) dual therapy versus either long-acting muscarinic antagonist (LAMA) or long-acting beta2-agonist (LABA) monotherapy. Individuals with COPD aged ≥40 years initiating a LAMA/LABA FDC dual therapy or a LAMA or LABA monotherapy (index date = first prescription date) between January 1, 2016 and December 31, 2016 were identified from a large US administrative claims database. Individuals were excluded if they were prescribed an inhaled corticosteroid (ICS) or ICS/LABA two months prior to the index date or were diagnosed with cystic fibrosis, idiopathic pulmonary fibrosis, or asthma.

View Article and Find Full Text PDF

Glypican-1 (GPC-1) has been recognized as biomarker of pancreatic cancer. Quantification of GPC-1 level is also pivotal to breast cancer and prostate cancer's patients. We hereby report the first biosensor for GPC-1 detection.

View Article and Find Full Text PDF

Background: Although asthma and chronic obstructive pulmonary disease (COPD) are clinically distinct diseases, they represent biologically diverse and overlapping clinical entities and it has been observed that they often co-occur. Some research and theorizing suggest there is a common comorbid condition termed asthma-chronic obstructive pulmonary disease overlap (ACO). However, the existence of ACO is controversial.

View Article and Find Full Text PDF

The objective of this study was to evaluate task performance and handling errors with soft mist inhalers (SMIs) or pressurized metered-dose inhalers (pMDIs) among patients with chronic obstructive pulmonary disease (COPD) experienced with, but not recently trained in, using these devices. This exploratory, noninterventional, simulated-use study (D5970R00004) assessed handling/usability of SMIs and pMDIs in inhaler-experienced patients with COPD (40-78 years; diagnosis ≥6 months). Patients received a device and instruction-for-use leaflet but no training and were recorded while performing tasks required for checking the device, priming, and dosing.

View Article and Find Full Text PDF

Background: Randomized clinical trials have shown long-acting mono bronchodilator therapy to be efficacious in improving lung function and dyspnea, while reducing exacerbations; however, less is known regarding the effectiveness in routine clinical practice. This study examined treatment patterns, rescue medication use, healthcare resource utilization and costs, and exacerbations in patients with chronic obstructive pulmonary disease (COPD) who initiated long-acting mono bronchodilator therapy in real-world settings.

Methods: This retrospective study used US claims data from adult patients with COPD initiating long-acting mono bronchodilator therapy between 1 January 2008 and 31 January 2015.

View Article and Find Full Text PDF

Chronic obstructive pulmonary disease (COPD) is characterized by chronic respiratory symptoms and airflow limitation, resulting from abnormalities in the airway and/or damage to the alveoli. Primary care physicians manage the healthcare of a large proportion of patients with COPD. In addition to determining the most appropriate medication regimen, which usually includes inhaled bronchodilators with or without inhaled corticosteroids, physicians are charged with optimizing inhalation device selection to facilitate effective drug delivery and patient adherence.

View Article and Find Full Text PDF

Background: The consistency of fixed airflow limitation status during treatment in patients with asthma is unknown.

Objective: The objective of this study was to determine the consistency of fixed airflow obstruction (FAO) status during treatment and effects on treatment response.

Methods: This post hoc analysis from a 12-week study (NCT00652002) assessed patients aged 12 years or more with moderate-to-severe asthma randomized to twice-daily budesonide/formoterol (BUD/FM) via pressurized metered-dose inhaler (pMDI) 320/9 μg, BUD pMDI 320 μg, FM 9 μg via dry-powder inhaler, or placebo.

View Article and Find Full Text PDF

Background: Budesonide is approved for delivery using a nebulized solution and dry-powder inhaler, but its use through a pressurized metered-dose inhaler (pMDI) in pediatric patients with asthma has not been determined.

Objective: To examine the efficacy and safety of 160 μg twice daily of budesonide through a pMDI vs placebo in children 6 to younger than 12 years with asthma and a demonstrated need for inhaled corticosteroids.

Methods: A 6-week, international, multicenter, double-blinded, parallel-group, phase 2 study randomized 304 pediatric patients (mean age, 9 years; 21.

View Article and Find Full Text PDF