Patients suffering from allergic rhinoconjunctivitis MedDRA version: 16.1 Level: LLT Classification code 10001728 Term: Allergic rhinoconjunctivitis System Organ Class: 100000004853
Conditions
Sponsors
Lofarma S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary objective is to assess the efficacy of sublingual immunotherapy with the allergoid LAIS® Grass tablets by the total combined score (TCS) regarding the rhinoconjunctivitis total symptom score (RTSS) of the six rhinoconjunctivitis symptoms (sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes and the total rescue medication score (TRMS).;Timepoint(s) of evaluation of this end point: The peak of the grass pollen season, defined by those 30 consecutive days per centre with the highest local grass pollen counts, starting with at least “moderate” pollen concentrations (stage 2 according to Deutscher Wetterdienst Medizin-Meteorologie, http://www.dwd.de) in the nearest pollen count station in that region ;Main Objective: The primary objective is to assess the efficacy of sublingual immunotherapy with the allergoid LAIS®Grass tablets by the total combined score (TCS) taking in account the rhinoconjunctivitis total symptom score (RTSS) of the six rhinoconjunctivitis symptoms (sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes and the total rescue medication score (TRMS) for the peak of the grass pollen season.;Secondary Objective: -Total Combined Score (TCS) (entire pollen season) - 6 individual symptom scores of the Rhinoconjunctivitis Symptom Score (peak month and entire pollen season) - Total Rhinoconjunctivitis Symptom Score (entire pollen season) - Total Rescue Medication Score (entire pollen season) - Asthma symptoms + use of asthma rescue medication (entire pollen season) - clinical benefit of SLIT (reduction of rhinoconjunctivitis symptoms and rhinitis symptom control) - Mean improvement in allergic severity S in CPT (baseline and visit V4) - changes of the threshold allergen concentration for a positive response within CPT (baseline and V4) -The redness of the eye in CPT (assessed by a central observer) - The “well days”(entire pollen season, maximum symptom sc | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Total Combined Score (TCS) (entire pollen season) - 6 individual symptom scores of the Rhinoconjunctivitis Symptom Score (peak month and entire pollen season) - Total Rhinoconjunctivitis Symptom Score (entire pollen season) - Total Rescue Medication Score (entire pollen season) - Asthma symptoms + use of asthma rescue medication (entire pollen season) - clinical benefit of SLIT (reduction of rhinoconjunctivitis symptoms and rhinitis symptom control) - Mean improvement in allergic severity S in CPT (baseline and visit V4) - changes of the threshold allergen concentration for a positive response within CPT (baseline and V4) -The redness of the eye in CPT (assessed by a central observer) - The “well days”(entire pollen season, maximum symptom score of 2, no rescue medication) - Assessment of grass specific IgG4 - A global evaluation (entire pollen season) - Safety (physical examinations, adverse Events, safety laboratory data) - Rhinoconjunctivitis Quality of Life (RQLQ);Timepoint(s) of evaluation of this end point: The peak of the grass pollen season, defined by those 30 consecutive days per centre with the highest local grass pollen counts, starting with at least “moderate” pollen concentrations (stage 2 according to Deutscher Wetterdienst Medizin-Meteorologie, http://www.dwd.de) in the nearest pollen count station in that region | — |
Countries
Germany
Contacts
Public ContactCoordinating investigator
Institut für Med. Statistik, Informatik u. Epidemiologie
Outcome results
None listed