Study on the efficacy and safety of three different doses of Lais Ambrosia tablets in patients with allergy to pollen of Ambrosia

Conditions: rhinoconjunctivitis allergic to ragweed pollen
MedDRA version: 14.1Level: PTClassification code 10054928Term: Allergy to plantsSystem Organ Class: 10021428 - Immune system disorders
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: EUCTR2011-004522-10-IT

Lead Sponsor: OFARMA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

-Signed Informed Consent -Male or female patients aged between 18 and 75 years with a documented history of at least two years of rhinitis and / or moderate to severe allergic rhinoconjunctivitis to ragweed pollen seasonal allergic asthma with or without controlled. -clinically relevant sensitization to ragweed pollen -Positive clinical history to ragweed pollen -Availability to attend the study visits requested by the protocol during the study participation -Negative Pregnancy Urinary test (if female in fertile age) -If woman is of fertile age, she has been using a highly efficacious method of birth control for at least one month before the study enrolment and agrees to continue the use for the entire duration of the study. -Capable to fully understand the protocol and be compliant to the instructions reported in the protocol itself. -Positive response to the TPN test.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

- Concomitant participation in other interventional clinical trials - Previous immunotherapy with ragweed allergen in the last 3 years. - Ongoing immunotherapy. - clinically relevant sensitization to other stagional aereous allergens such as Cupressacee, Graminacee, Parietaria, Artemisia, Betulacee, and/or to perennial allergens like house dust mites, cats and dogs dander. - 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 - Galactose-intolerance or malabsorption syndrome - Active tuberculosis - Generally inflammatory as well 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: to assess the efficacy and safety of treatment with sublingual specific immunotherapy (antiallergic vaccination) with allergoid monomeric ragweed (Ambrosia LAIS) in three different doses in patients with rhinoconjunctivitis to ragweed pollen;Secondary Objective: to document the safety of treatment with LAIS Ambrosia (incidence of adverse events);Primary end point(s): The efficacy of immunotherapy with sublingual tablets allergoid LAIS Ambrosia will be assessed through the measurement of individual variation in specific nasal provocation test (NPT) performed with Ambrosia Allerkin;Timepoint(s) of evaluation of this end point: - basal assesment before the randomization (same day of the first IMP administration)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Incidence of Adverse Events;Timepoint(s) of evaluation of this end point: Randomizzation visit (basal, pre-treatment),V2 after 30 +/- 2 dd since V1, V3 after 90 +/- 7 dd since V1 and V4 after 120 +/- 7 dd since V1.