E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Aspirin-exacerbated respiratory disease (AERD), also known as Samter's triad or Widal's triad, comprises the triad of Asthma, chronic rhinosinusitis with nasal polyps (CRwNP) and nonsteroidal anti-inflammatory drug (NSAID) intolerance |
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E.1.1.1 | Medical condition in easily understood language |
allergic Asthma, chronic rhinosinusitis with nasal polyps and Aspirin intolerance |
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E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To test the efficacy of omalizumab in patients with AERD regarding intolerance of salicylic acid after 6 months. This will be evaluated by oral drug provocation testing with low dose salicylic acid after 6 months of omalizumab Treatment. |
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E.2.2 | Secondary objectives of the trial |
To analyze the effects before and after 6 months of omalizumab Treatment on blood-related and Skin-related biomarkers of patients with AERD:
-Serum ECP, total IgE, Tryptase
-peripheral blood eosinophils
-reduction in total nasal endoscopic polyp scores after 6 months of Treatment (TPSs)
-reduction of Sino-Nasal Outcome Test-20 (SNOT-20), which measures the quality of life of patients with chronic rhinosinusitis
-reduction of allergic Asthma measured by spiromety and asthma control score |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Signed and dated informed consent form
-Age 18-70 years
-Male or female
-Diagnosed with AERD
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E.4 | Principal exclusion criteria |
Pregnancy
Clinically significant abnormal laboratory values and active infection (Tbs, HIV, Hepatitis A/B/C)
History of malignancy or immunodeficiency |
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E.5 End points |
E.5.1 | Primary end point(s) |
The Primary endpoint is the efficacy of omalizumab in the treatment of patients with AERD regarding the intolerance of salicylic acid after 6 months of Treatment. This will be evaluated by oral drug provocation testing with low dose salicylic acid after 6 months of omalizumab Treatment. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
-Reduction of polyps after 6 months of treatment, this will be evaluated by an ENT specialist. The polyps will be evaluated on each side by means of nasal endoscopy and grated based on polyp size, resulting in scores of 0 to 4 (TPSs)
-Reduction of allergic Asthma, measured by spirometry and Asthma control score. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
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 | No |
E.8.1.1 | Randomised | No |
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 | No |
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 | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
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 | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 6 |