Adult patients with stable persistent asthma MedDRA version: 9.1 Level: LLT Classification code 10049106 Term: Asthma chronic
Conditions
Interventions
Trade Name: Serevent Accuhaler
Product Name: Serevent Diskus
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: SALMETEROL XINAFOATE
CAS Number: 94749083
Concentration unit: µg microgram(s)
C
Sponsors
mibe GmbH Arzneimittel
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All of the following criteria have to be met for inclusion of a subject in the study: - men or women aged between 18 and 65 years - written informed consent of patient - current diagnosis of persistent asthma according to generally acknowledged criteria - daily regimen of inhaled corticosteroids in a low daily dose of 200 to 400 µg budesonide or equivalent for 4 weeks at least prior to study entry - a forced expiratory volume in one second (FEV1) of less than 80% of the predicted value or personal best (if known) - documented FEV1-reversibility of at least 12% (or at least 200 ml) from the pre-bronchodilator value - capable of understanding the directions for device usage 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
Exclusion criteria
Exclusion criteria: Subjects are to be excluded from the study when one or more of the following conditions are met: - daily regimen of inhaled long-acting beta-agonists (LABA) like formoterol or salmeterol for 4 weeks at least prior to study entry - respiratory tract infection less than 6 weeks prior to study entry - acute asthma attack, which led to hospitalisation less than 1 month prior to study entry - smokers less than 6 weeks prior to study entry - medical history of cystic fibrosis or bronchiectasis - systolic blood pressure more than 160 mm Hg, diastolic blood pressure more than 95mm Hg and heart rate > 100 bpm - known hypersensitivity to salmeterol or any of the ingredients of the study medication - thyrotoxicosis, pheochromocytoma, idiopathic subvalvular aortic stenosis, hypertrophic obstructive cardiomyopathy, aneurysm or other severe cardiovascular disorders - patients with a history of diabetes mellitus and an unbalanced metabolic status - other clinically significant conditions that might compromise patient safety, patient compliance, interfere with evaluations or preclude completion of the trial - previous treatment within one month prior to the beginning of the study or concomitant treatment with substances which may decrease the efficacy of the test substance(s) or may lead to drug interactions, as for example: xanthine derivatives, diuretics, laxatives, beta-adrenergic blockers - abnormal 12-lead ECG at screening recorded after at least 5 min of rest in supine position - prolonged QTc interval more than 460 ms for females and more than 440 ms for males - female patients: pregnancy or lactation - history of alcohol and/or drug and/or substance abuse - unwilling or unable to provide informed consent or to participate satisfactorily for the entire trial period - current participation in another clinical study or former participation in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Comparison of lung function after Salmeterol 50 µg DPI or Serevent Diskus measured as FEV1 determined as change from start to end of treatment;Secondary Objective: additional lung function variables (FVC, FEV1/FVC, FEF25%, FEF25-75%) between start and end of treatment, peak expiratory flow rate during treatment, sum score of asthma symptoms cough, wheezing, and dyspnoea, as well as the number of nocturnal awakenings during treatment, use of rescue medication during treatment;Primary end point(s): Change from start of treatment period of 2,5h-AUC of FEV1, evaluated at time points of 0, 5, 10, 15, 30, 60, 90, 120 and 150 min after treatment | — |
Countries
Germany
Outcome results
None listed