E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
mild to moderate persistent asthma |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Classification code | 10003553 |
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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 show therapeutic equivalence of fluticasone propionate (FP) 100 micrograms BID delivered through the Diskus(R) and FP 45 micrograms BID delivered through the Novolizer(R) (equivalent in terms of fine particle dose to nominal FP doses of 100 micrograms administered through the Diskus(R)) in patients with mild to moderate persistent asthma. |
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E.2.2 | Secondary objectives of the trial |
To show superiority of FP 45 micrograms BID delivered through the Novolizer(R) compared to placebo. To compare safety and tolerability of FP 100 micrograms BID delivered through the Diskus(R) to that of FP 45 micrograms BID delivered through the Novolizer(R). |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
At enrolment:
1. Male or female patients aged 18 to 75 years (inclusive) 2. Previously diagnosed bronchial asthma (for at least 6 months) of mild to moderate persistent intensity, baseline FEV1 > 60 % and <= 85 % of the value predicted for the patient´s age, height and sex. 3. FEV1 reversibility of >= 15 % or 200 ml within 15 to 30 minutes following inhalation of 2 puffs of 100 micrograms salbutamol. at randomisation: 4. Best FEV1 at visit V2 within +- 15 % of the best FEV1 obtained at screening (V1). |
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E.4 | Principal exclusion criteria |
Safety concerns:
1. Known hypersensitivity to FP, lactose or sympathomimetic drugs. 2. Pregnant or lactating female or female child-bearing potential not employing adequate contraception. 3. History of life-threatening asthma. 4. Exacerbation of bronchial asthma requiring hospitalisation during the last 6 months prior to this study. 5. Patients suffering from clinically significant renal, endocrine, haematological, hepatic, immunological, gastrointestinal, neurological, psychiatric, coronary artery or other cardiovascular disease (excluding secondary symptoms of asthma, e.g. right ventricular hypertrophy).
Lack of suitability for the trial:
6. Patients suffering from occupational asthma. 7. Acute bacterial or fungal respiratory infection or diagnosis of active or inactive lung tuberculosis. 8. Pre-treatment with inhaled glucocorticosteroids for the past 4 weeks. 9. Subjects with concomitant treatment or pre-treatment with systemic or depot glucocortocosteroids within the last 6 months prior to the start of the study. 10. Exposure to any cytochrome P450 (CYP) 3A4 inhibiting drug (e.g. ritonavir, ketoconazole, erythromycin, rifampicin etc.) within 14 days prior to study enrolment, except for regular use of oral hormonal contraceptives. 11. Use of prohibited therapies including long-acting inhaled or oral beta2-agonists, cromones, anticholinergic agents, methylxanthines, leukotriene antagonists, methotrexate, gold salts. 12. Neurological or psychiatric disease or therapy with anti-depressives or neuroleptics. 13. Malignant disease within the last 5 years. 14. Current smokers or smoking history > 10 pack-years (a pack-year is 20 cigarettes per day for one year). 15. Non-co-operative patients not able to understand the instructions for use of the devices or the electronic diaries. 16. Drug or alcohol abuse which would interfere with the subjects´proper completion of the protocol assignment. 17. Participation in another clinical study during or less than 2 months prior to this one.
Administrative reasons:
18. Lack of ability or willingness to give informed consent. 19. Anticipated non-availability for study visits/procedures. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Morning pre-dose FEV1 measurements obtained during visits (best of three readings fulfilling ATS criteria) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
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) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
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 | 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 |
partially double-blind, multinational, multicentre |
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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 | Yes |
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.8.5 | 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 | 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 | Information not present in EudraCT |
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 | 9 |
E.8.9.1 | In the Member State concerned days | |
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 | 9 |