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Population Pharmacokinetic Study involving different formulations of Salbutamol

Population Pharmacokinetic Study involving different formulations of Salbutamol

Nuno Filipe de Sousa Vale

OncoPharma Research Group, Center for Health Technology and Services Research (CINTESIS), Rua Doutor Plácido da Costa, 4200-450 Porto, Portugal CINTESIS@RISE, Faculty of Medicine, University of Porto, Alameda Professor Hernâni Monteiro, 4200-319 Porto, Portugal Department of Community Medicine, Health Information and Decision (MEDCIDS), Faculty of Medicine, University of Porto, Rua Doutor Plácido da Costa, 4200-450 Porto, Portugal

30 May 2023

Asthma is a common inflammatory disease of the lungs, whose prevalence has been increasing over the years, due to risk factors being more present in our daily lives. Asthma treatment, in addition to avoiding exposure to asthma attack-triggering factors, involves prescribing medication to relieve symptoms. Salbutamol is a short-acting β2-adrenergic agonist (SABA), used for the quick relief of asthma symptoms, namely bronchoconstriction (narrowing of the airways caused by tightening of the bronchi muscles, reducing airflow) that occurs in asthmatic events, which exists in different formulations. However, the Global Initiative for Asthma guidelines no longer recommend salbutamol monotherapy, due to the multiple studies that have emerged associating salbutamol with an increased worsening of symptoms and death. Clinical practice has not met the proposed guidelines and salbutamol continues to be prescribed for asthma symptom relief. The World Health Organization appoints salbutamol as one of the most effective and safe drugs, however, the idea of safety can be challenged. This drug has many reported adverse effects. Therefore, Precision Medicine has been increasingly important as it identifies the best treatment for the patient. Pharmacological simulation studies have contributed greatly to the advancement in this area and, in particular, to extend the knowledge of the pharmacokinetic (PK) profile of a drug, that is, understanding the behavior of a drug (how it is absorbed, distributed, metabolized and eliminated) in the body over a period of time. Studies of the PK profile of Salbutamol used in clinical practice in its various formulations have not been reported in the population. The purpose of this project is to develop a PK study of the different Salbutamol formulations, considering relevant characteristics of asthma patients, and contributing to the selection and adjustment of the optimal treatment for an individual with a particular set of characteristics. Optimization of the dose regimen of Salbutamol will also be performed so that adverse effects are minimized and, consequently, salbutamol treatment issues are addressed.

[{ "PostingID": 4671, "Title": "GSK-200921", "Description": "An open-label, randomised, cross-over, two cohort, single dose study in healthy volunteers to evaluate the Unit Dose Dry Powder Inhaler (UD-DPI) for the delivery of salbutamol and to compare the pharmacokinetic profile with the MDI and Diskus presentations." }]

Statistical Analysis Plan