Status:
COMPLETED
Dose Finding Study for Depigoid Birch: 4 Doses in Patients With Allergic Rhinitis/Rhinoconjunctivitis +-Asthma
Lead Sponsor:
Leti Pharma GmbH
Collaborating Sponsors:
Laboratorios LETI SL (Study Medication)
Pierrel Research Europe GmbH
Conditions:
Allergic Rhinitis and/or Rhinoconjunctivitis +- Asthma
Immunotherapy, Allergen
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Specific immunotherapy for subcutaneous application: Dose finding study to evaluate the correct dose. 4 concentrations of a birch pollen allergen extract are applied in this study. Duration of therap...
Detailed Description
This is a dose finding study and no therapeutic study. Patients will receive in 4-weekly intervals 5x injections of 0,5 ml of a solution of modified birch pollen extract outside the pollen season. The...
Eligibility Criteria
Inclusion
- Patients have provided an appropriately signed and dated informed consent prior to any study specific examination,
- Patients must be ≥ 18 and ≤ 70 years of age at Visit 1,
- Patients must have a perception of disease activity of at least 30 mm on a 100 mm visual analogue scale (VAS),
- Patients must have an FEV1 or PEF value \> 80% of the predicted normal value (for PEF: highest result of 3 measurements),
- 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,
- 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 and at least the size of histamine reference), and
- a positive CPT with a birch pollen concentration of up to 10,000 SQ-units/mL.
- Special criteria for patients with co-allergies
- Patients do not suffer from typical symptoms against co-allergens,
- Specific CAP-RAST against co-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 difference is \< 2, but must not be exposed to the specific allergen,
- Result of SPT against co-allergens \< result of SPT against birch pollen.
Exclusion
- Acute and chronic conjunctivitis,
- Infectious conjunctivitis,
- 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),
- Symptoms due to co-allergies,
- Persistent asthma, according to the Global Initiative for Asthma (GINA) Guidelines,
- Acute or chronic inflammatory or infectious airway diseases including recurrent acute or chronic sinusitis,
- Chronic structural diseases of the lung (e.g. emphysema or bronchiectasis),
- Diseases of the immune system including autoimmune and immune deficiencies,
- Any disease, which prohibits the use of adrenaline (e.g. hyperthyroidism),
- 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,
- Any malignant disease during the previous 5 years,
- Any significant abnormal laboratory parameter or alteration in the vital signs that could increase the risk for the study patient,
- Alcohol, drug, or medication abuse within the past year,
- Severe psychiatric, psychological, or neurological disorders,
- Use of immunotherapy against birch pollen within the last 5 years,
- Topical and systemic treatment with β-blockers,
- Treatment with substances interfering with the immune system within 1 week prior to Visit 2,
- Use of tranquillizers or psychoactive drugs within 1 week prior to Visit 1,
- Use of systemic corticosteroids within 3 months prior to Visit 1,
- Immunization with vaccines within 7 days prior to Visit 2,
- Patients with hypersensitivity to excipients of the investigational medicinal product,
- Patients expected to be non-compliant and/or not co-operative,
- Exposure to any investigational drug within one month or 6 half lives,
- Patients who have already participated in this study,
- Patients who are employees of the institution, or 1st grade relatives, or partners of the investigator,
- Any donation of germ cells, blood, organs, or bone marrow during the course of the study,
- Patients who are not contractually capable,
- Nursing (lactating) women or a positive pregnancy test at Visit 1.
- Persons who are jurisdictional or governmentally institutionalized.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
344 Patients enrolled
Trial Details
Trial ID
NCT01144429
Start Date
June 1 2010
End Date
May 1 2011
Last Update
June 8 2011
Active Locations (39)
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1
Dermatology Weber
Augsburg, Germany, 86163
2
Licca Klinik Dermatologie
Augsburg, Germany, 86179
3
Allergie-Centrum-Charité
Berlin, Germany, 10117
4
Klinische Froschung Berlin Mitte
Berlin, Germany, 10117