A multicenter, randomized, double-blind, double-dummy, placebo-controlled, 3-way crossover, single dose study, comparing the efficacy and safety of the Fluticasone/Salmeterol combination administered with Elpenhaler®db (Rolenium®) versus the innovative one (Seretide Diskus®) in patients with asthma.

Elpen Pharmaceutical Co. Inc.0 sites42 target enrollmentJune 19, 2008

Overview

No summary available.

Registry

who.int

Start Date

June 19, 2008

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Study subjects are eligible for participation if they meet all of the following criteria:
•1\.Age 18\-65 male or female.
•2\.Clinical diagnosis of asthma of ? 6 months prior to screening visit.
•3\.FEV1 \= 50% and \= 80% predicted.
•4\.Airways obstruction reversibility of at least 12% FEV1 (and an absolute increase of at least 0\.2 lt) after 400µg of inhaled salbutamol.
•5\.Stable asthma for at least 4 weeks prior to screening visit.
•6\.Inhaled steroids (ICS) at a stable dose within the previous 30 days of screening visit and short acting ß2\-agonists on an as needed basis.
•7\.PIF 30 \- 90 lt/min.
•8\.Patients willing to collaborate at the study visits.
•9\.Signed and dated written informed consent.

•Patients who meet any of the following exclusion criteria are not eligible for enrolment into the study:
•1\.History of other pulmonary disease, such as COPD, tuberculosis, cystic fibrosis, bronchiectasis.
•2\.Asthma exacerbation or respiratory infection within the previous 4 weeks.
•3\.Hospitalization for acute asthmatic symptoms requiring parenteral steroids or oral steroid dose increase within the previous 30 days of screening visit.
•4\.Heavy smokers (\>10 cigarettes per day) or any smoking history \=10 pack years.
•5\.Change of asthma medication within the previous 4 weeks of screening visit.
•6\.Seasonal asthma alone or patients who are likely to have a major exacerbation of their asthma due to seasonal effects during the study period.
•7\.Unusual responsiveness to sympathomimetic amines.
•8\.History of ischemic heart disease, severe heart failure, myocardial infarction, tachyarrhythmias, cardiac arrhythmias, third degree atrioventricular block, decompensated heart failure, idiopathic subvalvular aortic stenosis, hypertrophic obstructive cardiomyopathy, severe hypertension, prolongation of the QTc\>0\.44s, aneurysm, convulsive disorders, thyrotoxicosis and pheochromocytoma.
•9\.Other severe acute or chronic medical or psychiatric condition, which in the opinion of the investigator may increase the risk of patient’s participation or may confound the study results.