E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Adult patients with stable persistent asthma |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10049106 |
E.1.2 | Term | Asthma chronic |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Comparison of lung function after Salmeterol 50 µg DPI or Serevent Diskus measured as FEV1 determined as change from start to end of treatment |
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E.2.2 | Secondary objectives of the trial |
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 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last Patient Out will be the planned end of the trial |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 7 |
E.8.9.2 | In all countries concerned by the trial days | 0 |