Journal of Pharmacovigilance

Bronchoprovocation study of Albuterol inhalation on asthma patients: A Pharmacodynamic Bioequivalence Study

6^th Pharmacovigilance Congress

September 28-30, 2016 Toronto, Canada

Nailesh Patel and Rashmin Patel

Department of Pharmacology, S.K. Patel College of Pharmaceutical Education and Research, Ganpat University, Mehsana, Gujarat, India.

Posters & Accepted Abstracts: J Pharmacovigil

Abstract:

Objective: The main objective of the study is to determine the clinical endpoints bioequivalence between Test and Reference Albuterol inhalation formulation & to find out the superiority of test over placebo. Methods: The study was conducted in asthma patients of either gender with methacholine challenge. Patients with known surgical histories, known and suspected cases of allergies and pregnant woman�??s were excluded from this study. Total 260 patients were included. The design of the study was single-dose, double-blind, double dummy, randomized, crossover study with washout of at least 24 hours. Result: Post-dose PC20 or PD20, which are the provocative concentration or dose, respectively, of the methacholine challenge agent required to reduce the forced expiratory volume in one second (FEV1) by 20% following administration of differing doses of albuterol (or placebo) by inhalation is 15.84±0.02. The 20% reduction in FEV1 is determined relative to the saline FEV1 measured before the placebo or albuterol administration. A significant dose-effect relationship was present (p < 0.0001). Deviation from parallelism of the test and reference dose-response curves (p = 0.95) and differences in overall mean response between the two formulations (p = 0.68) were not significant. The calculated 90% CI was 78.86-144.87% for FEV1. There were no serious adverse events observed during the study. Conclusion: The 90% CI for the relative bioavailability (F) falls within the defined bioequivalence limit, i.e., 67.00-150.00%. Hence, it is concluded that Albuterol test formulation is bioequivalent to reference Albuterol formulation.

Biography :

Dr. Nailesh Patel is working at S.K. Patel College of Pharmaceutical Education and Research, Ganpat University, Mehsana, Gujarat, India.

Email: ptlnailesh@yahoo.co.in