Population Pharmacokinetic Study involving different formulations of Salbutamol

Lead Investigator: Nuno Filipe de Sousa Vale, University of Porto
Title of Proposal Research: Population Pharmacokinetic Study involving different formulations of Salbutamol
Vivli Data Request: 9280
Funding Source: None
Potential Conflicts of Interest: None

Summary of the Proposed Research:

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 bronchospasm 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 risk of exacerbations and mortality. 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. 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.

Requested Studies:

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.
Data Contributor: GlaxoSmithKline
Study ID: NCT01984086
Sponsor ID: 200921