Comparative PK Study of 2 Fluticasone/Salmeterol 250/50 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 250/50 mcg and ADVAIR DISKUS® 250/50 mcg in Healthy Volunteers under Fasting Conditions
IRAS ID
193522
Contact name
Brendan Colgan
Contact email
Sponsor organisation
Lupin Inc
Eudract number
2015-004719-18
Duration of Study in the UK
0 years, 0 months, 25 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.
Many inhaled treatments are currently licensed for the treatment of both asthma and COPD. Newer generation treatments typically combine a beta2 agonist and a corticosteroid component which has been shown to improve treatment outcomes.
This study will compare the safety profiles and pharmacokinetics of 2 inhalers administering both fluticasone and salmeterol in a controlled environment after satisfactory training in using the inhaler devices.
The Sponsor is developing a generic formulation of fluticasone propionate (corticosteroid component) and salmeterol xinafoate (beta2 agonist component) DPI to be substitutable for the reference (RLD), ADVAIR DISKUS 250/50 mcg.
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.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
15/EE/0406
Date of REC Opinion
6 Jan 2016
REC opinion
Further Information Favourable Opinion