Comparative PK Study of 2 Fluticasone/Salmeterol 500/50 mcg Inhalers
Research type
Research Study
Full title
An Open-Label, Randomized, 2-Period, 2-Treatment Crossover Single-Dose Study to Compare the Pharmacokinetic and Safety Profiles Following 2 Inhalations of Fluticasone Propionate and Salmeterol Xinafoate Dry Powder Inhaler 500/50 mcg and ADVAIR DISKUS® 500/50 mcg in Healthy Volunteers under Fasting Conditions
IRAS ID
193671
Contact name
Brendan J Colgan
Contact email
Sponsor organisation
Lupin Inc
Eudract number
2015-004720-57
Duration of Study in the UK
0 years, 1 months, 2 days
Research summary
Asthma is a chronic inflammatory disease of the bronchial tract characterized by reversible airway obstruction and bronchial hyper-responsiveness. Chronic obstructive pulmonary disease (COPD) is a debilitating respiratory illness characterized by airflow limitation that is not fully reversible and that is usually both progressive and associated with an abnormal inflammatory response of the lungs to noxious particles or gases.
Fluticasone propionate is a synthetic trifluorinated corticosteroid with potent anti inflammatory activity. Inflammation is an important component of the pathophysiology of asthma and corticosteroids have been shown to inhibit multiple inflammatory cells and mediators involved in the pathophysiology of asthma. Salmeterol xinafoate is a selective LABA. The therapeutic use of a combination of inhaled corticosteroid and an inhaled LABA for the treatment of asthma has been well established, offering advantages in both lung function improvement, as well as important clinical outcomes over the individual components alone.
The Sponsor is developing a generic formulation of fluticasone propionate and salmeterol xinafoate DPI to be substitutable for the reference (RLD), ADVAIR DISKUS 500/50 mcg.
REC name
HSC REC A
REC reference
15/NI/0238
Date of REC Opinion
7 Dec 2015
REC opinion
Further Information Favourable Opinion