E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Rhinitis and/or rhinoconjunctivitis with or without allergic asthma caused by clinical relevant sensitization against tree pollen. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10039083 |
E.1.2 | Term | Rhinitis |
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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 |
Comparison of the efficacy and tolerability of Depigoid with tree pollen extract ver-sus placebo in a subcutaneous immunotherapy over 2 pollen periods for patients with rhinitis and/or rhinoconjunctivitis with or without allergic asthma caused by clini-cal relevant sensitization against tree pollen. The main parameter in this study is the symptom load during the predefined pollen season. It is defined as the time weighted area under the curve of the daily symptom load including all days of the pollen season. The daily symptom load is the sum of the daily rescue medication score and the daily symptom severity score. The detailed method for calculating the rescue medication score and the symptom severity score will be defined in the blinded data review meeting and documented in the statistical analysis plan. |
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E.2.2 | Secondary objectives of the trial |
· Symptom score · Medication score · Specific antibody concentration (IgG4, IgE) · Pollencount for different time intervals · Nasal provocation test · Adverse events · Quality of life
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patients of both gender aged from 18 up to 65 years 2. Prior to study specific examinations the patient has to give his/her written informed consent 3. Patient’s perception of disease activity of at least 30 mm on a 100 mm visual analogue scale (VAS) 4. FEV1 or PEF > 70% of predicted normal value under normal conditions 5. The patients have to suffer from allergic complaints (rhinitis and/or rhinoconjunctivitis with or without allergic asthma) caused by clinical sensitization against tree pollen. The IgE mediated sensitization has to be verified by · Suggestive medical history · A positive skin prick test LETI for tree pollen, resulting in a wheal diameter of at least 3 mm > negative control reaction or '++' versus histamine · Specific IgE >=1 (CAP-RAST)
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E.4 | Principal exclusion criteria |
1. Pregnant or lactating women 2. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, unless they meet the following definition of postmenopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL or are using one or more of the following acceptable methods of contraception: a) surgical sterilization (e.g., bilateral tubal ligation, hysterectomy) b) hormonal contraception (implantable, patch, oral) c) double-barrier methods (any double combination of: IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap) Acceptable methods of contraception may include total abstinence at the discretion of the investigator in cases where the age, career, lifestyle, or sexual orientation of the patient ensures compliance. Periodic abstinence (e.g., calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception. Reliable contraception should be maintained throughout the study and for 30 days after study drug discontinuation.
3. Clinical relevant manifestation -defined as positive suggestive history within the last 12 months checked by a comprehensive questionnaire of symptoms, confirmed by a positive skin prick test (wheal diameter of at least 3 mm > negative control reaction or '++' versus histamine) as well as by specific IgE (RAST I or higher) -of the following allergies: · A perennial allergy against house dust mites (Dermatophagoides pteronyssinus or D. farinae), animal epithelia (of cats or dogs) or mould · A seasonal allergy against grasses (included rye) or weeds 4. Participation in an immunotherapy with comparable extracts within the last five years 5. Participation in another clinical trial within the last 3 months prior to this study 6. Smokers with a manifested bronchopathy 7. Alcohol or drug abusers 8. Persons, who are obviously not compliant 9. Patients, who are employees at the investigational site, relative or spouse of the investigator
Patients with other known concomitant diseases: 10. Acute tuberculosis 11. Acute and chronic inflammatory or infectious diseases (incl. target organ) 12. Advanced secondary changes at the target organ (e.g. emphysema or bronchiectasis) 13. Immunopathological diseases (e.g. of the liver, kidney, the nervous system, thyroid gland, rheumatic diseases) in which autoimmune mechanisms play a role 14. Immune deficiencies 15. Uncontrolled asthma, defined as FEV1 or PEF ≤ 70% of predicted normal value 16. Treatment with b-blockers 17. Malignancies during the last 5 years 18. Any disease which prohibits the use of adrenaline (e.g. hyperthyroidism) 19. Serious psychiatric/psychological disturbances 20. Concomitant treatment with substances interfering with the immune system
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E.5 End points |
E.5.1 | Primary end point(s) |
The main parameter in this study is the symptom load during the predefined pollen season. It is defined as the time weighted area under the curve of the daily symptom load including all days of the pollen season. The daily symptom load is the sum of the daily rescue medication score and the daily symptom severity score. The detailed method for calculating the rescue medication score and the symptom severity score will be defined in the blinded data review meeting and documented in the statistical analysis plan. |
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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 | No |
E.6.4 | Safety | Yes |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 40 |
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
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | |
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 | 10 |