Balligavi

Researchers are evaluating the pharmacodynamic bioequivalence of two albuterol sulfate inhalers in adults with stable mild asthma. This study aims to compare a test albuterol sulfate inhaler with a reference inhaler (ProAir HFA or FDA authorized generic) using a methacholine bronchoprovocation challenge to assess bronchodilation effects. The trial uses a randomized, double-blind, double-dummy, crossover design to study patients aged 20 to 65 years with mild asthma who have stable disease and are on a stable inhaled medication regimen. The study involves administering single doses of the test and reference inhalers in a crossover manner. Patients receive at least three doses of the reference product (0, 90, 180 mcg albuterol) and two doses of the test product (0, 90 mcg albuterol). Placebo inhalers are also used in a double-dummy design. The potency of albuterol sulfate is measured by the change in the provocative concentration of methacholine that causes a 20% decrease in lung function (FEV1), known as PC20. Participants will undergo pulmonary function tests to measure lung function and airway responsiveness before and after dosing. The study monitors the PC20 concentration 15 minutes after dosing as the primary outcome. Subjects must correctly use metered dose inhalers and perform reproducible lung function tests. Safety assessments and informed consent are part of the participation process, which lasts through the single-dose treatment and testing periods.