E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 | 10003555 |
E.1.2 | Term | Asthma bronchial |
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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 |
To demonstrate that that asthma control can be maintained with less than half the dose of inhaled corticosteroid and with less medical costs and that Foster™ is equivalent to the reference medication in maintaining the control of asthma |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Written informed consent obtained - Age between 18 and 65 years, limits included; - Clinical diagnosis of moderate persistent asthma for at least 6 months, according to GINA revised version 2005 guidelines and considering current treatment; - Male or female; - Forced expiratory volume (FEV1) or peak expiratory flow rate (PEFR) ³ 80% of the predicted normal value; - Treated with fluticasone 1000 mcg + salmeterol 100 mcg daily for at least 4 weeks at a stable dose; - Reporting no nocturnal symptoms or awakenings, no exacerbations, no limitations of activities, symptoms in ≤ 2 days and use of rescue medication ≤ 2 days per week, in the last 4 weeks; - Exhibiting a co-operative attitude and ability to be trained to correctly use the study devices and to complete the diary cards.
At the end of run in period (Week 8+0; Visit 3), patients will be recruited into the treatment period and randomized to treatment if they meet the following criterion: - asthma is controlled 1 in each of the last 4 weeks of run-in (no nocturnal symptoms or awakenings; no exacerbations; no limitations of activities; symptoms in £2 days; use of rescue medication ≤ 2 days; morning PEF ≥ 80% of predicted in every day) confirmed by reviewing the diary cards. |
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E.4 | Principal exclusion criteria |
- Inability to carry out pulmonary function testing; - Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) as defined by the NHLBI/WHO's GOLD guidelines;4 - Current smokers or recent (less than one year) ex-smokers with a smoking history of ≥ 10 pack/years; - History of near fatal asthma; - Evidence of symptomatic infection of the airways in the previous 8 weeks; - Three or more courses of oral corticosteroids or hospitalisation due to asthma during the previous 6 months; - Patients treated with anticholinergics and antihistamines during the previous 2 weeks, with topical or intranasal corticosteroids and leukotriene antagonists during the previous 4 weeks; - History or current evidence of heart failure, coronary artery disease, myocardial infarction, severe hypertension, cardiac arrhythmias; - Diabetes mellitus; - PTCA or CABG during the previous six months; - Patients with an abnormal QTc interval value in the ECG test, defined as >450 msec in males or > 470 msec in females; - Other haemodynamic relevant rhythm disturbances (including atrial flutter or atrial fibrillation with ventricular response, bradicardia (£55 bpm), evidence of atrial-ventricular (AV) block on ECG of more than 1st degree; - Clinically significant or unstable concurrent diseases: uncontrolled hyperthyroidism, significant hepatic impairment, poorly controlled pulmonary (tuberculosis, active mycotic infection of the lung), gastrointestinal (e.g. active peptic ulcer), neurological or haematological autoimmune diseases; - Cancer or any chronic diseases with prognosis <2 years; - Pregnant or lactating females or females of childbearing potential, who are not making use of an effective contraceptive method. A pregnancy test will be performed at screening in women of childbearing potential; - History of alcohol or drug abuse; - Patients treated with monoamine oxidase inhibitors, tricyclic antidepressants or beta-blockers as regular use; - Allergy, sensitivity or intolerance to study drugs and/or study drug formulation ingredients; - Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study; - Patients who received any investigational new drug within the last 12 weeks; - Patients who have been previously enrolled in this study.
At the end of run in period (Week 8+0; Visit 3), patients will not be randomized to treatment if they do not completely meet the definition of "controlled asthma". These subjects will be considered screening failures and will not count against the planned number to be recruited. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primaryvariable is the morning PEF as mesured at home by the patient. The measurement is attempted three times, before drug administration, and the beast (the largest) result obtained is recorded in diary card. For the assessment of result, the mean morning PEFof the last two weeks of the run-in period, and the change is considered.
For a measurement to be considered valid, at least 10/14 measurement in two weeks shell be available, and not less then 4/7 measurements for each of the 2 weeks considered. |
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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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 76 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 8 |