E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
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 investigate the effect of 78 weeks omalizumab treatment on airway inflammation in moderate to severe allergic asthma patients with persistent symptoms and evidence of airway inflammation despite treatment with inhaled corticosteroids and long acting beta-agonists. The primary endpoint supporting this objective will be the number of sub-epithelial eosinophils following 78 treatment with omalizumab, compared to placebo, as assessed in bronchial biopsy samples. |
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E.2.2 | Secondary objectives of the trial |
To investigate the effect of 78 weeks omalizumab treatment on other markers of airway inflammation. The secondary endpoints supporting this objective will be the number of sub-epithelial mast cells and CD4+ T-lymphocytes following 78 treatment with omalizumab, compared to placebo, as assessed in bronchial biopsy samples. To investigate the effect of 78 weeks omalizumab treatment on airway remodeling. The secondary endpoint supporting this objective is the thickness of the lamina reticularis, compared to placebo, as assessed in bronchial biopsy samples. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Male or female (post menopausal or surgically steralized or using approved contraception) patients with moderate to severe allergic asthma with persistent symptoms depsite receiving an inhaled corticosteroids and long acting beta-agonist.
18-60 years of age, with >= 2% eosinophiila in induced sputum at both screening visits.
Body weight between 20 and 150kg, with a serum total IgE level between 30 and 700 IU/mL.
Patients must have a positive skin prick test or RAST test to at least one perennial aeroallergen documented within the past 2 years, to which the patient will be exposed on a regular basis.
FEV1 must be greater than or equal to 60% of the predicted value for the patient, which must be stable (within 10%) at the second screening visit and the randomization visit.
Patients must be receiving high dose inhaled corticosteroids (at least 800ug per day BDP or equivalent) and a regular inhaled long actin beta-agonist for at least 3 months prior to screening.
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E.4 | Principal exclusion criteria |
Current active smokers or patients with >= 10 pack-year smoking history.
Patients who have been treated for an asthma exacerbation during the 4 weeks prior to randomization.
Patients who have received omalizumab previously.
Patients with elevated serum IgE levels for reasons other than allergy.
Patients with a history of allergic reactions to local anaesthetics to be used during bronchoscopy, any clotting abnormality, history of chronic CO2 retention, and any patient who has been intubated because of the asthma.
Any patient with a current or historial condition that excludes the patient from undergoing bronchoscopy, as assessed by the investigator. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The number of tissue sub-epithelial eosinophils following 78 weeks treatment. |
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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 | Yes |
E.6.5 | Efficacy | Yes |
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 | Yes |
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) | No |
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 | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 5 |
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
|
Last visit of the past 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 | 3 |
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 | 3 |
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 |