allergic rhinoconjunctivitis MedDRA version: 14.0 Level: LLT Classification code 10001728 Term: Allergic rhinoconjunctivitis System Organ Class: 10015919 - Eye disorders
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 controlled seasonal allergic asthma [From the Global Strategy for Asthma Management and Prevention, Global Initiative for Asthma (GINA) 2007.] • Clinically relevant sensitization to grass pollen. Patients with clinically relevant sensitization to other seasonal aero-allergens, for example ragweed, trees or rye may be included. However, patients with clinically relevant sensitization to perennial allergens like house dust mites, cats and dogs dander may not be included. • Positive clinical history of grass pollen induced allergic rhinitis, proven by o the majority of clinical symptoms appearing during the appropriate season for grass pollen, and o positive skin prick test, and o positive response to conjunctival provocation testing (CPT) with one of the three solutions. The conjunctival allergen challenge will be conducted with solutions containing 100, 1,000 and 10,000 AU/ml grass allergens CPT is considered positive if the response is stage II or higher. Stage Findings 0 no subjective or visible reaction I itching, reddening, foreign body sensation II stage I and in addition tearing, vasodilation of conjunctiva, bulbi III stage II and in addition vasodilation and erythema of conjunctiva tarsi, blepharospasm IV stage III and in addition chemosis, lid swelling • Signed and dated patient’s Informed Consent. 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 110 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: • Simultaneous participation in other clinical trials • Previous immunotherapy with grass allergens within the last 5 years • Ongoing immunotherapy • Patients being in any relationship or dependence with the sponsor and/or investigator Other reasons contra-indicating 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 • Predominant perennial allergic rhinitis • Partly controlled or uncontrolled asthma • Chronic asthma or emphysema, particularly with a FEV <70% of the predicted value • Chronic asthma or emphysema, particularly with a PEF <70% of the individual optimum value • Patients with Galactose-intolerance, Lactase-deficiency, Glucose-Galactose-malabsorption • Active tuberculosis • Generally inflammatory as well as severe acute and chronic inflammatory diseases • Irreversible secondary disorders at the target organ (e.g. emphysema, bronchoectasis) • Immune deficiency (for example induced by immunosuppressive drugs) • Physician diagnosed diseases of the liver, spleen, nervous system, thyroidal gland as well as rheumatic diseases, based on an autoimmune mechanism • Malignancy • Alcohol abuse • Patients treated with ß-blockers and/or other contra-indicated drugs • Locally applied ß-blockers (eye drops) are not allowed • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The efficacy of sublingual immunotherapy with the allergoid LAIS® Grass tablets will be assessed by the number of patients per treatment group with a change of the response threshold to induce a positive conjunctival provocation test (CPT), according to the evaluation defined by Riechelmann between the visits V1 and V4. The titrated conjunctival allergen challenge will be conducted with solutions containing 100, 1,000 and 10,000 AU/ml grass allergens. Change of the response threshold: For each of the four treatment groups the changes of the threshold allergen concentration for a positive CPT response will be compared. It is the aim of this trial to document that a large proportion of patients can be protected from reacting to their allergen by a 12 week course of SLIT. The protection is documented by an improved response threshold for a positive CPT. ;Secondary Objective: Physical examinations and the description of the adverse events (frequency, intensity, severity and duration of adverse events) during the treatment with LAIS® Grass tablets;Primary end point(s): The primary objective is to assess the efficacy of a sublingual immunotherapy with the allergoid LAIS® Grass tablets by the number of patients per treatment group with a change of the response threshold to induce a positive conjunctival provocation test (CPT), according to the evaluation defined by Riechelmann between the visits V1 and V4. The primary outcome parameter is the reaction to the conjunctival allergen challenge as documented in the CRF. In line with national and international guidelines the test will be considered positive, if the patient reacts with distinctive clinical symptoms to the application of the allergen. ;Timepoint(s) of evaluation of this end point: day 0 and day 84 of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): physical examinations and the description of the adverse events;Timepoint(s) of evaluation of this end point: Visit 1, Visit 2, Visit 3 and Visit 4 of the study | — |
Countries
Germany
Contacts
Public ContactCoordinating investigator
Institut für Med. Statistik, Informatik u. Epidemiologie
Outcome results
None listed