A study, which aims to evaluate the efficacy and safety of LAIS® Birch-Alder tablets in patients suffering from allergic inflammation of the conjunctiva and rhinitis caused by birch polle

• Conditions: Patients suffering from allergic rhinoconjunctivitis; MedDRA version: 17.1Level: LLTClassification code 10001728Term: Allergic rhinoconjunctivitisSystem Organ Class: 100000004853; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2013-002129-43-DE
• Lead Sponsor: ofarma S.p.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08-12
• Last Update Posted: 6 October 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•Female or male patients aged 18–75 years with a history of at least two years of tree pollen induced allergic rhinitis and/or allergic rhinoconjunctivitis with or without seasonal controlled allergic asthma [From the Global Strategy for Asthma Management and Prevention, Global Initiative for Asthma (GINA) 2012. Available from: http://www.ginasthma.org]
•Clinical sensitization to tree pollen. Patients with sensitization to perennial allergens like mites, cats and dogs may be included, in the case that these sensitizations are not clinically relevant during the evaluation season
•Positive clinical history of tree pollen, proven by:
-the majority of clinical symptoms appearing during the appropriate season for tree,
-specific IgE reactivity to tree pollen CAP-radioallergoabsorbent test (CAP-RAST) = 2 (0.70 kU/L)
-positive screening Skin Prick Test (wheal diameter > 3 mm, negative control < 2 mm)
-Positive response to conjunctival provocation testing with at least 10,000 SQ-E/ml of tree allergens at both visits V0 AND V1. The conjunctival allergen challenge will be conducted with solutions containing 100, 1,000 and 10,000 SQ-E/ml tree allergens.
Additionally the difference in reacting concentration at visits V0 and V1 must not exceed one step of allergen concentration. Otherwise the test will be considered as irregular and the patient must be excluded.
In the case that there is a difference between the reactive concentrations at visit V0 and V1 the higher concentration will be assumed as baseline reactivity.
•planned antiallergic or antiasthmatic treatment with the following drugs: local Levocabastine (eye), Loratadine (oral), Beclomethasone (nasal) or inhaled corticosteroids with long-acting ß2-agonists
•Compliance and ability of the patient to complete a diary card for self-evaluation of the symptoms and antisymptomatic medication
•Signed and dated patient’s Informed Consent

Special criteria for patients with co-sensitizations: for all patients with co-sensitizations all of the following inclusion criteria must be fulfilled:
•Patients do not suffer from typical symptoms against coseasonal prevalent allergens
•Specific CAP-RAST results to coseasonal prevalent allergens less than the CAP-RAST result to tree pollen (the difference has to be = 1), the patients with coseasonal prevalent allergies against animal dander must not be exposed to the specific allergen
•The result of the Skin Prick Test against co-allergens is less than the result of the Skin Prick Test against tree

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 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

•Simultaneous participation in other clinical trials
•Previous immunotherapy with birch-alder allergens or cross-reacting allergens within the last 5 years
•Ongoing immunotherapy for any allergen
•Patients being in any relationship or dependency with the sponsor and/or investigator
•Other reasons contraindicating an inclusion into the trial according to the investigator’s estimation (e.g. poor compliance, inability of the patient to understand study documents and instructions)
•Existing or intended pregnancy, lactation and/or lack of adequate contraceptive protection (see Annex XX.3)
•Predominant perennial allergic rhinitis
•Partly controlled or uncontrolled asthma
•Chronic asthma or emphysema, particularly with a FEV <70% of the predicted value and/or PEF <70% of the individual optimum value
•Infections of the oral cavity with severe symptoms
•Patients with Galactose-intolerance, Lactase-deficiency, Glucose-Galactose-malabsorption
•Patients with nasal abnormalities and/or polyps
•Active tuberculosis
•Generally inflammatory as well severe acute and chronic inflammatory diseases
•Immune deficiency (for example induced by immunosuppressive drugs)
•Auto-immune disorders
•Physician diagnosed diseases of the liver, spleen, nervous system, thyroidal gland as well as rheumatic diseases, based on an autoimmune mechanism
•Malignancy
•Alcohol abuse as well as drug and/or medication abuse
•Contra-indication for adrenalin (for example, acute or chronic symptomatic coronary heart disease, severe hypertension, hyperthyroidism)
•Completed or ongoing long-term treatment with tranquilizer or psycho active drugs
•Completed or ongoing treatment with anti-IgE-antibody
•Patients treated with contra-indicated drugs.

Study & Design

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