albuterol sulfate / Generic mfg. - LARVOL DELTA

Amneal has received permission from the Food and Drug Administration for albuterol sulfate inhalation aerosol (90 mcg per actuation). (Drug Store News) - "The product is the generic of Teva Respiratory’s ProAir HFA (albuterol sulfate inhalation aerosol)....Albuterol sulfate inhalation aerosol is indicated for the treatment or prevention of bronchospasm in adults and children 12 years of age and older with reversible obstructive airway disease."

ANDA • Respiratory Diseases

EDSAMS: ED-Initiated School-based Asthma Medication Supervision (clinicaltrials.gov) - P4 | N=13 | Completed | Sponsor: University of Arizona | N=90 ➔ 13

Enrollment change • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Late Breaking Abstract - Improved aerosol drug delivery during adult invasive mechanical ventilation with independent humidity control (ERS 2025) - "In a bench study setup, albuterol sulfate solution was nebulized into an adult IMV circuit with a vibrating-mesh nebulizer...Regional lung deposition simulations suggest that around 40% of the measured delivered dose would deposit in healthy lungs. In conclusion, we found that the delivered dose and thus the lung deposited dose can be improved significantly by enabling independent humidity control inside the adult IMV circuit during aerosol drug delivery."

Clinical • Late-breaking abstract

Preliminary investigation of concurrent aerosol delivery with the HAMILTON-HF90 system (ERS 2025) - " 2000 µg of Albuterol Sulphate was aerosolised with the Aerogen Solo vibrating mesh nebuliser (VMN) and Pro-X controller (Aerogen Ltd., Ire) placed in-line with the HAMILTON-HF90 (Hamilton Medical AG, CH) high flow system... The HAMILTON-HF90 high flow system with in-line Aerogen Solo VMN and Pro-X controller successfully delivered aerosol to the level of the trachea of an unassisted, spontaneously breathing adult nose- throat model."

Respiratory Diseases

Functional Studies of Novel Genes Mutated in Primary Ciliary Dyskinesia II: Genotype to Phenotype (clinicaltrials.gov) - P1 | N=27 | Completed | Sponsor: University of North Carolina, Chapel Hill | Recruiting ➔ Completed

Trial completion • Otorhinolaryngology • Respiratory Diseases

BE Study of Albuterol Sulfate Inhalation Aerosol 90 mcg Per Actuation in Patients With Stable Mild Asthma (clinicaltrials.gov) - P3 | N=120 | Completed | Sponsor: Cipla Ltd. | Not yet recruiting ➔ Completed

Trial completion • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Assessment of drug permeability using a small airway microphysiological system. (PubMed, Front Pharmacol) - "Insignificant nonspecific binding to the MPS was observed with albuterol sulfate, formoterol fumarate, and olodaterol hydrochloride (HCl), while fluticasone furoate showed significant nonspecific binding as only 6%-44% of the drug was recovered at 30 and 120 min, respectively. Taken together, the small airway MPS recapitulated relevant cell types and many morphological features in the lung. The apparent permeabilities measured indicated that albuterol sulfate and formoterol fumarate would be categorized as highly permeable, while olodaterol HCl would be categorized as a low permeable drug."

Journal

Mechanisms of Interferon Gamma-primed Mesenchymal Stromal Cells (MSCs) for Moderate-to-severe Persistent Asthma (clinicaltrials.gov) - P1 | N=1 | Terminated | Sponsor: Emory University | N=12 ➔ 1 | Recruiting ➔ Terminated; The study terminated due to funding ending.

Enrollment change • Trial termination • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Developing a Machine Learning Model That Uses Actively Measured Acoustic Resonance to Quantitate Response to Bronchodilators (ATS 2025) - " Participants (403 subjects: 123 COPD, 102 Asthma, 178 Healthy controls) wore the Sylvee active acoustic sensor on their chest as they performed a metronome breathing maneuver and underwent standard spirometry tests before and after nebulization using Albuterol sulfate... This study demonstrates the feasibility of using Sylvee sensor data and machine learning to identify patients' response to bronchoactive medications. This opens the possibility of using Sylvee as a non-invasive, affordable, and user-friendly alternative that can accurately monitor medication effects in a range of settings from the clinic to patients' homes. This will enable personalized treatment adjustments and enhance physicians' ability to deliver regular, real-time follow-up for patients."

Late-breaking abstract • Machine learning • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

Estimating the Greenhouse Gas Emissions of Outpatient Inhalers at Stanford Medicine (ATS 2025) - "The three most prescribed inhalers were albuterol sulfate, budesonide-formoterol, and fluticasone propionate; these metered-dose inhalers alone accounted for 92% of inhaler prescriptions and 90% of inhaler-related emissions over the study period. Metered-dose inhalers accounted for the majority of inhaler prescription orders and nearly all of the inhaler-related greenhouse gas emissions from selected Stanford Medicine outpatient clinics. The carbon equivalent emissions associated with metered-dose inhaler prescriptions at these clinics were equivalent to driving an average gasoline-powered passenger vehicle for 335,218 miles. While the increased use of propellant-free dry powder and soft mist inhalers may reduce the carbon footprint of respiratory care, individual prescribing decisions must be weighed against clinical and cost considerations."

Clinical • Immunology

A Performance Comparison of Three Nebulizers Delivering a Combination of Ipratropium/Albuterol Inhalation Solution (ATS 2025) - "This study aimed to compare three nebulizers by assessing in-vitro Fine Droplet Mass (FDM<4.7μm) and aerosol characteristics of a combination of ipratropium/albuterol over time. AeroEclipse® II BAN® Nebulizer (AE), AirLife™ Misty Fast™ (MF) and Circulaire® II (CA) devices (n=5) were filled with 1 DuoNeb® (ipratropium bromide 0.5 mg/ albuterol sulfate 3.0 mg) vial. All nebulizers showed consistent incremental increases in delivered doses of each medication minute by minute. The AeroEclipse® BAN® Nebulizer provided the highest FDM in substantially less time compared to the other nebulizers tested making this a reasonable option for recognizing a time savings by offering a timed treatment option. The effectiveness of small volume nebulizers can vary greatly, making it crucial to choose the right one to optimize drug delivery and achieve the best therapeutic outcomes."

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

Prediction of Myasthenia Gravis (MG) Crisis Events by a Machine Learning (ML) Algorithm (ISPOR 2025) - " Patients with MG crises at year 1 (n=332) were significantly ( P <0.05) more likely than those without MG crises at year 1 (n=7277) to be older at MG index date (mean±SD: 61.5±14.5 vs 57.1±14.8 years, respectively), have higher rates of comorbidities/symptoms (eg, shortness of breath [21.1% vs 9.3%], dysphagia [20.0% vs 9.0%]), and have certain prescription claims (eg, albuterol sulfate [11.7% vs 4.9%], amlodipine besylate [11.4% vs 5.6%]). This novel analysis using a ML algorithm identified several key patient-relevant characteristics, disease symptoms, and comorbidities that are risk factors for experiencing an MG crisis, and these results may help inform future treatment strategies to reduce the risk of MG crises."

Machine learning • CNS Disorders • Cough • Gastrointestinal Disorder • Myasthenia Gravis • Pulmonary Disease • Respiratory Diseases

Albuterol Digihaler in COPD Disease Management: A Real-World Study to Assess Digihaler Inhalation Parameters, Thresholds and Their Use to Identify Deterioration in Clinical Practice. (PubMed, Int J Chron Obstruct Pulmon Dis) - "Real-time rescue albuterol Digihaler (albuterol sulfate) results for peak inspiratory flow (PIF), rescue inhaler usage and inhalation volume (InV) were assessed in 20 COPD patients over 6 months...A combination of 3 alert thresholds was present in 59% of patients within the 2 weeks prior to a COPD exacerbation. Our study suggests that alert thresholds based on Digihaler device-measured physiologic parameters may have value in a predictive model for clinical deterioration in COPD."

Clinical • Journal • Real-world evidence • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Characterization of Bronchodilator Response in Children With Bronchiolitis Using Phenotypic and Genotypic Features (clinicaltrials.gov) - P3 | N=400 | Recruiting | Sponsor: Nemours Children's Clinic

New P3 trial • Pulmonary Disease • Respiratory Diseases

Impact of normal, obstructive, and restrictive breathing patterns on aerosol drug delivery with jet and mesh nebulizers in simulated spontaneously breathing adults. (PubMed, Can J Respir Ther) - "Albuterol sulfate (2.5 mg/3 mL) was delivered with jet (MistyMax 10) and mesh nebulizers (Aerogen Ultra)...Aerosol delivery with the mesh nebulizer was up to 3-fold more than the jet nebulizer regardless of the breathing pattern tested in this study (p < 0.05). This study highlights the necessity for tailored aerosol therapy strategies to optimize drug delivery in patients with different respiratory conditions.."

Journal

Quantification of Health Care Worker Model to Secondhand Exposure of Aerosols During Nebulization Treatment. (PubMed, Respir Care) - "A jet nebulizer delivered albuterol sulfate (15 mg/3 mL) in 2 consecutive sessions, totaling 30 mg in 30 min... The HCW models were exposed to fugitive aerosol particles during nebulization, with inhaled doses from 0.1% to 0.3%. Although exposure was low, further in vivo studies are needed to assess potential health risks with prolonged exposure."

Journal

A Study to Test if a Fixed-Dose Combination of Fluticasone Propionate/Albuterol Sulfate is Effective in Preventing Asthma Exacerbations (clinicaltrials.gov) - P3 | N=2196 | Recruiting | Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. | Active, not recruiting ➔ Recruiting

Enrollment open • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

A Study to Test if a Fixed-Dose Combination of Fluticasone Propionate/Albuterol Sulfate is Effective in Preventing Asthma Exacerbations (clinicaltrials.gov) - P3 | N=2196 | Active, not recruiting | Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. | Recruiting ➔ Active, not recruiting

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

Inhaled albuterol rapidly decreases whole blood potassium and increases plasma insulin concentrations, with peak effects 30 minutes after administration in cats. (PubMed, J Am Vet Med Assoc) - "In a prospective, randomized study between June 2023 and January 2024, 20 client-owned cats received albuterol sulfate at a low dose (90 µg) or high dose (360 µg)...Albuterol rapidly decreases blood potassium concentrations in part by stimulating endogenous insulin secretion in cats without dose-dependent effects or clinically meaningful changes in HR or glucose concentrations. Inhaled albuterol may be useful to decrease blood potassium concentrations in hyperkalemic cats."

Journal

Aerosol Delivery to Simulated Spontaneously Breathing Tracheostomized Adult Patients With Heated Humidified High Flow Oxygenation. (PubMed, Respir Care) - "Albuterol sulfate (2.5 mg/3 mL) was aerosolized via a vibrating mesh nebulizer in-line with HHHF (Airvo2)... During aerosol delivery via in-line placement of vibrating mesh nebulizer with HHHF in a tracheostomized model, the inhaled dose increased as flow decreased. Distal nebulizer placement resulted in higher inhaled doses than proximal placement with the tracheostomy adapter at all flows and with the tracheostomy collar at 15 L/min."

Journal

Optimization of Albuterol Delivery via Anesthesia Bag in Pediatric Critical Care. (PubMed, Pharmaceutics) - " Using a simulated pediatric lung model (ASL 5000) with the semi-open Mapleson anesthesia circuit, 2.5 mg/3 mL of albuterol sulfate solution was nebulized to a viral/bacterial filter (Respiguard 202)... Modifying the anesthesia breathing circuit significantly improved aerosol drug delivery efficiency. Our findings suggest that current clinical practices for nebulized drug delivery are inefficient and can be markedly improved with simple adjustments in nebulizer positioning and gas flow within the circuit."

Journal • Anesthesia • Critical care • Fatigue • Pediatrics

Pharmacodynamic Equivalence of the Test and Reference Metered Dose Inhalers (MDIs) Containing Albuterol Sulfate in Adult Patients with Stable Mild Asthma (clinicaltrials.gov) - P=N/A | N=148 | Recruiting | Sponsor: Intech Biopharm Ltd. | Trial completion date: Apr 2024 ➔ Jun 2025 | Trial primary completion date: Mar 2024 ➔ Jan 2025

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

Breathing Easy in Maricopa County, Arizona: Empowering K-12 Schools With a Novel Nurse Coaching Model to Facilitate Implementation of a County-Wide School-Based Stock Albuterol Inhaler Program. (PubMed, J Sch Nurs) - "To reduce chronic school absenteeism and morbidity and mortality among school-aged children, the prompt administration of albuterol sulfate in schools remains vital...Most events (78%) were compliant with the protocol for administering the stock inhaler to a student. These findings suggest that implementing a practice facilitation model is feasible and important for enhancing fidelity to program requirements."

Journal • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

A 3D Model of the Human Lung Airway for Evaluating Permeability of Inhaled Drugs. (PubMed, ACS Pharmacol Transl Sci) - "To understand how the characterized ALI quality attributes influenced the absorption of inhaled drugs through the epithelial-endothelial barrier, we measured the permeability and epithelial intracellular concentrations of albuterol sulfate (AL), formoterol fumarate (FO), and fluticasone furoate (FL). Due to its high lipophilicity, FL showed a higher intracellular concentration (17.4%) compared to AL and FO, but also a 73.1% loss of the compound over 3 h due to nonspecific binding, with a P app as low as 1.3 × 10-7 cm/s. While the model exhibited physiologically relevant properties, its utility in estimating the permeability of inhaled drugs may be drug-specific, warranting further optimization and study."

Journal

A Randomized, Double-Blind, Placebo-Controlled Trial on Efficacy and Safety of Fluticasone Propionate/Albuterol Sulfate Combination in Participants 12 Years and Older With Asthma (clinicaltrials.gov) - P3 | N=724 | Recruiting | Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases