Randomized, double-blind, parallel group, multicenter study to evaluate theefficacy and safety of four doses of depigmented glutaraldehyde polymerized birch pollen allergenic extract (Depigoid® Birch) in patients with allergic rhinitis and/or rhinoconjunctivitis with or without intermittent asthma

• Conditions: Allergic rhinitis and/or rhinoconjunctivitis, with or without intermittent asthma, causedby birch pollen.; MedDRA version: 9.1Level: LLTClassification code 10001723Term: Allergic rhinitis; MedDRA version: 9.1Level: LLTClassification code 10039097Term: Rhinoconjunctivitis

• Registration Number: EUCTR2008-008448-26-LT
• Lead Sponsor: ETI Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06-12
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

Patients will be eligible for inclusion into the study only if all of the following criteria
are met:
1. Patients have provided an appropriately signed and dated informed consent prior to any study specific examination,
2. Patients must be = 18 and = 70 years of age at Visit 1,
3. Patients must have a perception of disease activity of at least 30 mm on a 100 mm
visual analogue scale (VAS),
4. Patients must have an FEV1 or PEF value > 80% of the predicted normal value, (for PEF: highest result of 3 measurements),
5. 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 birch pollen,
6. IgE-mediated sensitization has to be verified by:
• suggestive medical history, and
• specific IgE against birch pollen (CAP-Rast = 2), and
• a positive skin prick test (SPT) to birch pollen (the SPT is considered positive
if it results in a wheal diameter of at least 3 mm and at least the size of
histamine reference), and
• a positive conjunctival provocation test (CPT) with a birch pollen concentration
of 10,000 SQ-units/mL. Ten minutes after applying the drop, 4 symptom
categories (eye redness, weeping, itching or burning, nose dripping or blockage)
will be assessed and scored from 0 to 3 (0 = absent, 1 = mild,
2 = moderate, 3 = severe). The CPT is evaluated as positive if a sum score
of 5 is reached (21). The following concentrations will be applied: 100, 330,
1,000, 3,300 and 10,000 SQ-units/mL.

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:

7. Patients do not suffer from typical symptoms against co-allergens,
8. Specific CAP-RAST against co-allergens (perennial allergens) < CAP-RAST against
birch pollen (the difference has to be = 2), patients with co-allergens against animal dander can be randomized even if the CAP RAST is = 2, but must not be exposed to the specific allergen.

9. Result of SPT against co-allergens < result of SPT against birch pollen.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

A patient will not be eligible for inclusion in this study if any of the following criteria
are met:
1. Acute and chronic conjunctivitis,
2. Infectious conjunctivitis,
3. 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),
4. Symptoms due to co-allergies,
5. Persistent asthma, according to the Global Initiative for Asthma (GINA) Guidelines (see Section 7.9.1),
6. Acute or chronic inflammatory or infectious airway diseases including recurrent
acute or chronic sinusitis,
7. Chronic structural diseases of the lung (e.g. emphysema or bronchiectasis),
8. Diseases of the immune system including autoimmune and immune deficiencies,
9. Any disease, which prohibits the use of adrenaline (e.g. hyperthyroidism),
10. 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,
11. Any malignant disease during the previous 5 years,
12. Any significant abnormal laboratory parameter or alteration in the vital signs that
could increase the risk for the study patient,
13. Alcohol, drug, or medication abuse within the past year,
14. Severe psychiatric, psychological, or neurological disorders,
15. Use of immunotherapy against birch pollen within the
last 5 years,
16. Topical and systemic treatment with ß-blockers,
17. Treatment with substances interfering with the immune system within 1 week prior to Visit 2,
18. Use of tranquillizers or psychoactive drugs within 1 week prior to Visit 1,
19. Use of systemic corticosteroids within 3 months prior to Visit 1,
20. Immunization with vaccines within 7 days prior to Visit 2,
21. Patients with hypersensitivity to excipients of the investigational medicinal
product,
22. Patients expected to be non-compliant and/or not co-operative,
23. Participation in any other clinical study within 30 days prior to Visit 2,
24. Patients who have already participated in this study,
25. Patients who are employees of the institution, or 1st grade relatives, or partners of the investigator,
26. Any donation of germ cells, blood, organs, or bone marrow during the course of
the study,
27. Patients who are not contractually capable,
28. Nursing (lactating) women or a positive pregnancy test at Visit 1. In general,
women of childbearing potential should be using highly effective contraception to
participate in clinical studies. A highly effective method of birth control is defined
as one which results in a low failure rate (i.e., less than 1% per year) when used
consistently and correctly, such as implants, injectables, combined oral
contraceptives, some IUDs, sexual abstinence or vasectomised partner.
29. Persons who are jurisdictionally or governmentally institutionalized.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified