A study which aims at evaluating the efficacy and safety of LAIS® Grass tablets in patients suffering from g from allergic inflammation of the conjunctiva and rhinitis which are caused by grass polle

Phase 1

• Conditions: Patients suffering from allergic rhinoconjunctivitis; MedDRA version: 16.1Level: LLTClassification code 10001728Term: Allergic rhinoconjunctivitisSystem Organ Class: 100000004853; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2012-004916-79-DE
• Lead Sponsor: ofarma S.p.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11-19
• Last Update Posted: 8 January 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Female or male patients aged 18–75 years with a history of at least two years of grass 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 grass 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 grass pollen, proven by:
- the majority of clinical symptoms appearing during the appropriate season for grass,
- specific IgE reactivity to grass pollen: CAP-RAST results to Phl p1 or Phl p5b = class 2 (0.70 kU/L) AND CAP-RAST results to Phl p1 or Phl p5b > CAP-RAST results Phl p7 or Phl p12
- positive screening skin prick test (wheal diameter > 3 mm, negative control < 2 mm),
- positive response to conjunctival provocation testing (CPT) with at least 10.000 SQ-E/ml of allergenes at both visits V0 and V1.
- planned antiallergic or antiasthmatic treatment with the following drugs: local Levocabastine (eye), Loratadine (oral), Budesonide (nasal) or inhaled corticosteroids with long-acting beta2-agonists.
• Retrospective Total Symptom Score (RRTSS) during the previous grass pollen season greater than or equal to 8
• 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 caused by co-allergens during the grass-pollen season e.g. patients with sensitization to animal dander are not exposed to the specific allergen
• Specific IgE to perennially prevalent co-allergens (animal dander, house dust mites) or the co-seasonally prevalent co-allergen alternaria are less (the difference has to be at least 1 CAP RAST class less (= 1) than sIgE to grass pollen (Phl p1 or Phl p5b)
• The result of the skin prick test to perennially prevalent co-allergens allergens (animal dander, house dust mites) or to the seasonally prevalent co-allergen alternaria is less than the result to grass 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 160
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 grass allergens or cross-reacting allergens within the last 5 years,
• Ongoing immunotherapy with any allergen
• Patients being in any relationship or dependence 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