A study comparing SAL/FP PulmoJet inhaler to Seretide Diskus® inhaler
Research type
Research Study
Full title
A Randomised, Double Blind, Single Dose, Crossover Study, in Subjects with Mild to Moderate Asthma, to Compare the Pharmacodynamic (Bronchodilator) Responses of 12.5/250 μg and 50/250 μg Salmeterol/Fluticasone Propionate (SAL/FP) Delivered Via a Novel Dry Powder Inhaler Device PulmoJet® Versus the Seretide Diskus® 50/250
IRAS ID
172892
Contact name
Mohammed Haq
Contact email
Sponsor organisation
Sanofi-Aventis AG
Eudract number
2014-005047-40
Duration of Study in the UK
0 years, 8 months, 0 days
Research summary
Asthma is a serious public health problem throughout the world, affecting about 300 million people of all ages. When uncontrolled, asthma can place severe limitations on daily life, and is sometimes fatal.
The Sponsor, Sanofi-Aventis AG is developing a new inhaler called PulmoJet SAL/FP®, which contains fluticasone propionate (FP) and salmeterol (SAL) (referred to as the “study drug” throughout the remainder of this document). This study drug should provide long-term relief in the treatment of asthma.
Salmeterol is a substance, which dilates (opens) the airway tubes called bronchi (bronchodilator). It is a so-called long acting β-2-adrenoceptor agonist (short: β2 agonist) that is capable to activate the receptors of the airway muscles. This causes the muscles surrounding the bronchi to relax, the airways dilate and the breathing becomes easier.
Fluticasone propionate is a so-called inhaled corticosteroid. This means that the drug has anti inflammatory effects and decrease the hypersensitivity of the airways.
A specific combination of both of these drugs is already marketed in several European countries, e.g. under the name Seretide® Diskus® in the UK and Bulgaria and under the name Viani® Diskus® in Germany, respectively.
Unlike the already approved treatments with this combination of drugs, this new product is distinguished by a new inhalation device, the PulmoJet SAL/FP® inhaler.
The results obtained from previous clinical studies indicate that PulmoJet SAL/FP® is safe and well tolerated.
This clinical study will aim to show that the bronchodilator effect of the salmeterol component of PulmoJet SAL/FP® and the salmeterol component of the marketed products are similar when tested in patients with asthma. This study will compare the study drug to a similar product already on the market, namely Seretide® Diskus® referred to as the “comparator drug”.
Approximately 120 participants with mild to moderate asthma participating in this study at approximately 10 study centres throughout the United Kingdom (UK), Germany and Bulgaria.
REC name
London - Harrow Research Ethics Committee
REC reference
15/LO/0411
Date of REC Opinion
30 Mar 2015
REC opinion
Further Information Favourable Opinion