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 | 10003553 |
E.1.2 | Term | Asthma |
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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 the equivalence in terms of FEV1 between CHF1535 (beclometasone dipropionate plus formoterol, 400/24 µg daily) and an equipotent dose of Seretide® Diskus® (fluticasone plus salmeterol, 500/100 µg /daily) in asthmatic patients already controlled on fluticasone plus salmeterol, 500/100 µg /daily. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the efficacy of the two treatments in terms of pulmonary function, use of rescue medication, maintaining asthma control, to evaluate the safety profile through adverse events (AEs) and adverse drug reactions (ADRs) reporting, overnight urinary cortisol-creatinine ratio (OUCC), vital signs, and to assess treatment costs trough a cost minimisation analysis, comparing the total asthma-related direct medical costs and indirect costs in patients allocated to CHF1535 or to Seretide® Diskus®. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Written informed consent obtained 2. Adult male and female (equal to and between 18 and 65 years) 3. Clinical diagnosis of controlled asthma according to Global Strategy for Asthma Management and Prevention (GINA) revised version 2007 in the previous week before study entry: - no daytime symptoms (twice or less/week) - no limitations of activities - no nocturnal symptoms/awakenings - no need for reliever/rescue medications (twice or less/week) - lung function (FEV1) greater than or equal to 80% predicted or personal best (if known) 4. Patients treated with fluticasone 500 µg + salmeterol 100 µg daily for greater than or equal to 4 weeks 5. A co-operative attitude and ability to correctly use the device and to complete the diary cards |
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E.4 | Principal exclusion criteria |
1. Inability to carry out pulmonary function testing; 2. Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) as defined by the National Heart Lung and Blood Institute/World Health Organisation (NHLBI/WHO) Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines; 3. History of near fatal asthma; 4. Evidence of severe asthma exacerbation or symptomatic infection of the lower airways in the previous six months; 5. Three or more courses of oral corticosteroids or hospitalisation due to asthma during the previous 6 months; 6. Patients treated with long-acting Beta2-agonists (LABAs) other than salmeterol, anticholinergics, and leukotriene antagonists during the previous 4 weeks; 7. Current smokers or recent (less than one year) ex-smokers defined as smoking at least 15 packs/year; 8. Clinically significant or unstable concurrent disease : e.g. uncontrolled hyperthyroidism, uncontrolled diabetes mellitus or other endocrine disease; significant hepatic impairment; significant renal impairment; significant other pulmonary disease; cardiovascular disease; gastrointestinal disease; neurological disease; haematological disease, autoimmune disorders, that may interfere with patient?s safety, compliance, or study evaluations, according to the investigators opinion; 9. Patients with a serum potassium value below or equal to 3.5 mEq/L 10. Patients with QTc interval (Bazetts formula) higher than 450 msec at screening visit 1; 11. Cancer or any chronic diseases with prognosis < 2 years; 12. Female subjects: pregnant or with active desire to be pregnant, lactating mother or lack of efficient contraception in a subject with child-bearing potential (i.e. contraceptive methods other than oral contraceptives, IUD, tubal ligature). A pregnancy test in urine is to be carried out in women of a fertile age at screening 13. Significant alcohol consumption or drug abuse; 14. Patients treated with beta-blockers as regular use; 15. Patients treated with monoamine oxidase inhibitor, tricyclic antidepressants and Selective Serotonin Re-uptake Inhibitors (SSRIs), unless already taken at stable doses at the screening visit 16. Allergy, sensitivity or intolerance to study drugs and/or study drug formulation ingredients; 17. Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study; 18. Patients who received any investigational new drug within the last 12 weeks; 19. Patients with asthma exacerbations during the run-in period will also be excluded from the study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
pre-dose morning FEV1 measured at clinic visit 5 |
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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 | Yes |
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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | No |
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 | 11 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 60 |
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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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 | 10 |
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 | 10 |
E.8.9.2 | In all countries concerned by the trial days | 0 |