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.
- Conditions
- Chronic Persistent AsthmaMedDRA version: 9.1Level: LLTClassification code 10003561Term: Asthma, unspecified
- Registration Number
- EUCTR2008-000193-21-GR
- Lead Sponsor
- Elpen Pharmaceutical Co. Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 42
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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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.
10.Pregnancy or lactation.
11.Women of childbearing potential who refuse to use contraception.
12.Allergy to the study medications and their excipients.
13.Any use of a ß-blocker, of a NSAID or an antiallergic/antihistaminic medication within 2 weeks prior to screening visit.
14.Any use of potent CYP3A4 inhibitors, including but not limited to ketoconazole, SSRIs and ritonavir within 2 weeks prior to screening visit.
15.Any use of nonpotassium-sparing diuretics (such as loop or thiazide diuretics) within 2 weeks prior to screening visit.
16.Any use of cromones, MAO inhibitors, tricyclic antidepressants, or drugs known to prolong the QTc interval within 2 weeks prior to screening visit.
17.Any investigational medication within 12 weeks prior to screening visit.
18.Record of previous non-compliance.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method