Badanie bioekwiwalencji inhalatora z flutikazonem propionianem i salmeterolem xinafoate u zdrowych ochotników z astmą lub POChP

Bronchial asthma is a condition where the airways become narrow and inflamed, making breathing difficult. Chronic obstructive pulmonary disease is a long‑term lung disease that also causes airflow limitation. Both diseases are often treated with an inhaler that contains a steroid to reduce inflammation and a long‑acting bronchodilator to keep the airways open. The steroid used in this type of inhaler is fluticasone propionate and the bronchodilator is salmeterol xinafoate. The medication is delivered as an inhalation powder that is breathed in through the mouth.

The aim of the study is to find out whether a new inhaler product provides the same amount of medicine in the body as the already approved product ADVAIR DISKUS. Healthy adult volunteers will receive a single dose of each inhaler on separate occasions while fasting, with a break between the two administrations, and will stay in the clinic for observation.

During the visit, blood samples will be taken to see how much of the drug reaches the bloodstream and for how long it stays there, and safety checks such as vital signs and lung function will be performed. The study does not involve any change in the volunteers’ usual health status and any adverse reactions will be treated immediately.