E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated | |
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 2 actuations of FP 100 micrograms BID delivered through the Diskus(R) and 2 actuations of 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 moderate to severe asthma. |
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E.2.2 | Secondary objectives of the trial |
To compare safety and tolerability of 2 actuations of FP 100 micrograms BID delivered through the Diskus(R) to that of 2 actuations 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 moderate to severe persistent intensity that required asthma pharmacotherapy over the 6 months preceding the study. 3. Pharmacotherapy of bronchial asthma in a stable dosage for the past 4 weeks with budesonide 400 - 1,600 micrograms/day or equivalent dose of another ICS. 4. FEV1 >= 50 % predicted 5. FEV1 reversibility of >= 15 % or 200 ml within 15 to 30 minutes following inhalation of 2 puffs of 100 micrograms salbutamol.
At randomisation: 6. Asthma stability during the last 2 weeks confirmed by: - a current best FEV1 within +- 15 % of the best pre-dose FEV1 obtained at the previous visit, - use of rescue medication (salbutamol) not more than 4 times a day (at maximum 8 actuations), - no more than 2 night-time awakenings requiring salbutamol per week. 7. Adequate compliance (adequate completion of AM2+ assessments and administration of run-in medication to be checked by dose counter readings). 8. Pre-dose FEV1 >= 50 % predicted 9. Pre-dose FEV1 <= 80 % predicted, limited to group B patients who have been treated with a daily dose of 200 micrograms fluticasone throughout the run-in period only.
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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 of 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). 6. patients suffering from cataract or glaucoma.
Lack of suitability for the trial:
7. Mild persistent asthma defined by FEV1 > 80 % predicted, treated with low dose ICS monotherapy of 400 - 600 micrograms budesonide per day (or equivalent dose of another ICS) and no use of additional LABA. 8. Patients suffering from occupational asthma. 9. Acute bacterial or fungal respiratory infection or diagnosis of active or inactive lung tuberculosis. 10. Subjects whose inhaled glucocorticosteroid dosage and/or other antiasthmatic controller therapy had to be changed within the last 4 weeks prior to the study start. 11. Use of systemic or depot glucocortocosteroids within the last 6 months 12. 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. 13. Use of prohibited therapies as specified in chapter 6.3.1.1 of the study protocol 14. Neurological or psychiatric disease or therapy with anti-depressives or neuroleptics. 15. Malignant disease within the last 5 years. 16. Current smokers or smoking history > 10 pack-years (a pack-year is 20 cigarettes per day for one year). 17. Uncooperative patients not able to understand the instructions for use of inhalation devices or the electronic diaries. 18. Drug or alcohol abuse which would interfere with the subject´s proper completion of the protocol assignment. 19. Participation in another clinical study less than 2 months prior to or during this one.
Administrative reasons:
20. Lack of ability or willingness to give informed consent. 21. 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 | No |
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 |
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 | 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.8.5 | 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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Definition of the end of the trial is the last visit of the last patient |
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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 | 12 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 12 |