E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
allergic rhino-conjunctivitis |
allergisk høfeber |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Body processes [G] - Immune system processes [G12] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10039085 |
E.1.2 | Term | Rhinitis allergic |
E.1.2 | System Organ Class | 10038738 - Respiratory, thoracic and mediastinal disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10010744 |
E.1.2 | Term | Conjunctivitis allergic |
E.1.2 | System Organ Class | 10015919 - Eye disorders |
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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 |
We would like to evaluate the effect of Intralymphatic Immunotherpy (ILIT) on patients with rhinoconjunctivitis due to grass pollen allergy.
1. Is the clinical effect comparable to that of Subcutaneous Immunotherapy (SCIT) measured in BasoSCIT (funded by Lundbeck grant R32-A1482)
2. Does a booster injection after one year confer additional symptom relief
3. Can enumerating plasma cells one week after injection monitor ILIT?
4. Is the effect on Basophil activation (BAT EC50) a useful tool to document clinical effect?
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E.2.2 | Secondary objectives of the trial |
Establish a new method of immunotherapy, intralymphatic immunotherapy at the Allergy Center, Dept. of Respiratory Diseases, Aarhus University Hospital |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
We have planned to do a pilot-study, before starting the main study, to establish the technical procedures needed in the main study: intralymphatic injections, flow-cytometric cell investigation |
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E.3 | Principal inclusion criteria |
history of seasonal rhino-conjunctivitis during the grass pollen season
positive skin prick test for grass pollen extract
informed consent given |
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E.4 | Principal exclusion criteria |
severe comorbidity
uncontrolled asthma bronchiale
pregnancy |
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E.5 End points |
E.5.1 | Primary end point(s) |
- a significant decrease in allergic symptoms during grass pollen season
-a decrease in basophil sensitivity measured by basophil activation test (10 fold)
-detection of specific plasma cells one week after injections |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. during the grass pollen seasons in 2014 and 2015
2. 3 weeks after injections
3. 1 week after injections |
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E.5.2 | Secondary end point(s) |
-a possible positive effect of a booster injection after one year
-changes in specific immunoglobulins (IgE, IgX) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. season 2015
2. measurements performed througout the whole study, 2013-2015 |
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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 | No |
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 | 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 | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
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 | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |