E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Allergic rhinitis and/or rhinoconjunctivitis with or without intermittent asthma. |
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E.1.1.1 | Medical condition in easily understood language |
Hay fever with or without asthma due to birch pollen. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10001728 |
E.1.2 | Term | Allergic rhinoconjunctivitis |
E.1.2 | System Organ Class | 10015919 - Eye disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10039776 |
E.1.2 | Term | Seasonal allergic rhinitis |
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 | LLT |
E.1.2 | Classification code | 10001705 |
E.1.2 | Term | Allergic asthma |
E.1.2 | System Organ Class | 10038738 - Respiratory, thoracic and mediastinal 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 |
To demonstrate superiority of Depiquick® Birch (1,000 DPP/mL) over Depiquick®-matching placebo (0 DPP/mL) with regard to efficacy of intraseasonal SIT as assessed by the combined symptom and medication score (SMS) for rhinitis/rhinoconjunctivitis on the basis of the primary tree pollen exposition time. |
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E.2.2 | Secondary objectives of the trial |
- SMS for rhinitis/rhinoconjunctivitis on the basis of all days with a certain median symptom score - Onset of action of intraseasonal specific short-term immunotherapy - Symptom score on the basis of the primary tree pollen exposition time - Symptom score on the basis of all days with a certain median symptom score - Medication score on the basis of the primary tree pollen exposition time - Medication score on the basis of all days with a certain median symptom score - Medication score by patients’ assessment - Health-related quality of life - Percentage of well days - Global evaluation of efficacy and tolerability |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Subject must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study related activity is performed. For adolescents (≥ 12 and < 18 years of age), a legal representative will sign the informed study consent. 2. Patients must be ≥ 12 and ≤ 70 years of age at visit 1 3. If visit 1 is conducted before the pollen season (no allergic symptoms): Patients must have a perception of disease activity during previous tree pollen seasons of at least 30 mm on a 100 mm visual analogue scale (VAS) 4. Patients must be capable to complete the eDiary on a daily basis from visit 2 to visit 8 (at the discretion of the investigator) 5. Patients must experience significant allergic symptoms (defined by symptom score ≥ 2) at visit 2 6. Patients must complain about allergic rhinitis and/or rhinoconjunctivitis symptoms for at least 2 years with or without intermittent asthma symptoms, caused by clinical sensitization against tree pollen 7. IgE-mediated sensitization has to be verified by: - suggestive medical history, and - specific IgE against birch pollen (CAP-RAST ≥ 2), and - a positive SPT to birch pollen (the SPT is considered positive if it results in a wheal diameter of at least 3 mm),
Special criteria for patients with co-allergies: For all patients with co-allergies as a result of sensitization against grass and/or weed pollen and/or perennial allergens (e.g. house dust mites, animal dander), all of the following inclusion criteria must be fulfilled: 8. Patients have to be asymptomatic against co-allergens such as grass or weed pollen, house dust mites, cat and dog 9. Specific CAP-RAST co-allergen < birch, as specified below: - Grass and house dust mites: specific CAP-RAST of < 2 with a difference to birch of ≥ 2 and a negative SPT - Cats and dogs: exposed to animal: specific CAP-RAST animal < birch with a difference to birch of ≥ 2 and an SPT wheal diameter co-allergen < birch; not exposed to animal: CAP-RAST animal < birch - All other co-allergens: difference in specific CAP RAST co-allergen to birch of ≥ 2 and an SPT wheal diameter co-allergen < birch 10. Patients not fulfilling inclusion criterion number 9 are eligible for the study if a negative provocation test(s) for the co-allergen(s) not fulfilling the co-allergy criteria is(are) available. The provocation test(s) must not be older than 12 months at visit 1. |
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E.4 | Principal exclusion criteria |
1. History of significant clinical manifestations of allergy as a result of sensitization against grass or weed pollen and perennial allergens (e.g. house dust mites). Patients are not allowed to enter the study: - with typical symptoms against co-allergens such as grass/weed pollen, house dust mites, cat and dog - with CAP-RAST co allergen ≥ birch (not applicable if negative provocation test for co-allergen not older than 12 months is available) 2. FEV1 or PEF value ≤ 80% of the predicted normal value (for PEF: highest result of 3 measurements) 3. Persistent asthma, according to the Global Initiative for Asthma (GINA) Guidelines 4. Acute or chronic inflammatory or infectious airway diseases including recurrent acute or chronic sinusitis and nasal polyposis 5. Chronic structural diseases of the lung (e.g. emphysema or bronchiectasis) 6. Diseases of the immune system including autoimmune and immune deficiencies 7. Any disease, which prohibits the use of adrenaline (e.g. hyperthyroidism) 8. Severe uncontrolled diseases that could increase the risk for the patients participating in the study, which include but are not limited to the following: cardiovascular insufficiency, any severe or unstable lung diseases, endocrine diseases, clinically significant renal or hepatic diseases, or hematological disorders 9. Any malignant disease during the previous 5 years 10. Any significant abnormal laboratory parameter or alteration in the vital signs that could increase the risk for the study patient 11. Alcohol, drug, or medication abuse within the past year 12. Severe psychiatric, psychological, or neurological disorders 13. Use of immunotherapy against birch or tree pollen within the last 5 years 14. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 halflives of enrollment, whichever is longer 15. Topical and systemic treatment with β-blockers 16. Treatment with substances interfering with the immune system within 1 week prior to Visit 2 17. Use of tranquillizers or psychoactive drugs within 1 week prior to Visit 1 18. Use of systemic corticosteroids within 4 weeks prior to Visit 1 19. Immunization with vaccines within 7 days prior to Visit 2 20. Any condition which could interfere with the study objectives 21. Patients with hypersensitivity to excipients (see Section 6.2) of the investigational medicinal product 22. Patients expected to be non-compliant and/or not co-operative 23. Patients who have already participated in this study 24. Patients who are employees of the institution, or 1st grade relatives, or partners of the investigator 25. Women ■ who are pregnant or breast feeding (pregnancy defined as the state of a female after conception and until the termination of gestation, confirmed by a positive urine pregnancy test. ■ who are menstruating and capable of becoming pregnant and not practicing a medically approved method of contraception (Pearl Index <1) during and up to at least 4 weeks after the end of treatment. A negative pregnancy test (urine) for all women and for girlsentering menarche is required with sufficient lead time before inclusion 26. Persons who are jurisdictionally or governmentally institutionalized |
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E.5 End points |
E.5.1 | Primary end point(s) |
- combined symptom and rescue medication score (SMS) over the primary exposition time |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
- daily during primary exposition time
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E.5.2 | Secondary end point(s) |
- combined symptom and rescue medication score (SMS) over the secondary exposition time - quality of life |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
- daily during secondary exposition time - visit 2, 4, 6, 7 |
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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.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 40 |
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 | Yes |
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 | 0 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 8 |
E.8.9.2 | In all countries concerned by the trial days | 0 |