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 | 10001705 |
E.1.2 | Term | Allergic 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 a reduction in innate immune response (assessed by priming marker A17 on blood neutrophils) in subjects with asthma treated with the salmeterol/fluticasone propionate combination product (SFC) 50/250 mcg bd compared to a treatment with fluticasone propionate (FP) 500 mcg bd alone (week 0 - week 24) |
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E.2.2 | Secondary objectives of the trial |
To evaluate whether there is a dose dependent reduction in the innate immune response (assessed by priming marker A17 on blood neutrophils) by comparing FP 250 mcg bd and FP 500 mcb bd (week 0 - week 12) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion criteria for entry into the run-in period: 1. Male or female subjects ≥18 years ≤ 50 years 2. Allergic asthma: positive skin prick test for at least one aeroallergen or RAST 3. Documented history of asthma according to GINA guidelines for a period of at least 6 months 3. Subjects who have received regular treatment with FP at a dose of 250 mcg bd or equivalent with or without a LABA for at least 4 weeks before start of the run-in period, at a constant dose 4. Subjects with history of recurrent episodes of wheezing, breathlessness, chest tigthness and/or coughing in the previous year 5. Subjects who are able to use a DISKUS inhaler 6. Subjects who are able to perform reproducible lung function tests at Visit 1 (variation FEV1 smaller than 5% between the two best measurements)
Inclusion criteria for entry into the treatment period: 1. Subjects with an FEV1% of predicted bigger than 70% 2. ACT score smaller then 25 after the run-in period 3. Negative pregnancy urine test when of child bearing potential |
|
E.4 | Principal exclusion criteria |
Exclusion criteria for entry into the run-in period: 1. Subjects who have been hospitalised for their asthma within 4 weeks of visit 1 2. Subjects who had an acute upper respiratory tract infection within 4 weeks or a lower respiratory tract infection within 4 weeks prior to visit 1 3. Subjects who received oral, parental, or depot corticosteroids within 4 weeks prior to visit 1 4. Subjects who have a known respiratory disorder other than asthma and/or systemic/thoracic abnormalities which influence normal lung function 5. Subjects who hae received any investigational drugs within 4 weeks of visit 1 6. Subjects with a known or suspected hypersensitivity to inhaled steroids, beta2-agonists or lactose 7. Subjects who use any medication that significantly inhibits the cytochrome P450 subfamily enzyme CYP3A4, including ritonavir, ketoconazole, itraconazole and erythromycin 8. Subjects who concurrently participate in another clinical study 9. Subjects who have previously been randomised in this study 10. Subjects who have currently smoke or subjects who smoked in the last 6 months prior to the study 11. Subjects with hepatic impairment or other significant disease.
Exclusion criteria for entry into the treatment period: 1. Any change in their run-in asthma medication 2. Non-compliance with the run-in medication (smaller than 70%) |
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E.5 End points |
E.5.1 | Primary end point(s) |
Mean change in neutrophil priming in blood as assessed by marker A17 |
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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 | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
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) | 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 | 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 | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 0 |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |