Efficacy and Safety of LAIS® in patients with allergic rhinoconjunctivitis to ragweed polle

Conditions: Patients with allergic rhinoconjunctivities to ragweed pollen with or without asthma
MedDRA version: 17.1Level: SOCClassification code 10021428Term: Immune system disordersSystem Organ Class: 10021428 - Immune system disorders
Therapeutic area: Body processes [G] - Immune system processes [G12]

Registration Number: EUCTR2014-004431-38-HU

Lead Sponsor: ofarma S.p.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 228

Inclusion Criteria

•Female or male patients aged 18-75 years with a physician diagnosed history of at least two years of ragweed pollen induced allergic rhinitis and/or allergic rhinoconjunctivitis with/without seasonal allergic controlled asthma (level I-II of Global Strategy for Asthma Management and Prevention, Global Initiative for Asthma).
•Clinically relevant sensitization to ragweed pollen.
•Positive clinical history of allergy due to ragweed pollen, proven by:
-Clinical symptoms appearing mostly related to ragweed allergens.
-Demonstration of a value of specific IgE to ragweed pollen (Amb a1> 2.5 KU/L) with ImmunoCAP test.
-Positive skin prick test for ragweed pollen (wheal diameter > 5mm, negative control < 2mm).
•Retrospective global symptoms score >8.
•Compliance and ability of the patient to complete a diary card for self-evaluation of the symptoms and anti-symptomatic medication.
•Availability to be present at the visits of the protocol for the duration of the study.
•Urinary negative pregnancy test (if women of childbearing age).
•Fertile women willing to use contraception.
•Women of childbearing potential that allow to use a highly effective method of birth control beginning to adopt at least one month prior to study enrollment and continuing to use it for the duration of the study.
•Signed and dated patient’s Informed Consent (subjects needed to be willing to give informed written consent and to adhere to dose and visit schedules).

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 28

Exclusion Criteria

•Simultaneous participation in other clinical trials.
•Patients who had used any investigational drugs within 30 days of screening.
•Previous immunotherapy with ragweed allergens or cross reacting allergens within the last 5 years.
•Ongoing immunotherapy with any allergen.
•Subjects who are unlikely to be able to complete the trial or likely to travel for extended periods during the season (not exposed or low exposition during the last week of August and the first and second week of September).
•Patients being in any relationship or dependency 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).
•Predominant perennial allergic rhinitis.
•Patients with clinically relevant sensitization to other overlapping seasonal aero-allergens (alternaria, parietaria, etc), occurring during the ragweed season, cannot be included. In addition, patients with clinically relevant sensitization to perennial allergens like mites and animal dander of cat or dog (if living at home).
•Sensitization to wormwood with demonstration of specific IgE for Art v1 > 2.5 KU/L with ImmunoCAP test.
•Severe asthma, uncontrolled asthma or requiring daily continuative treatment with medium/high inhaled corticosteroids or bronchodilators.
•Lung function with a FEV <70% of the predicted value and /or <70% of the individual optimum value.
•Severe atopic dermatitis.
•Infections of the oral cavity.
•Rhino-sinusitis, rhinitis medicamentosa, polyposis.
•Patients with already diagnosed galactose-intolerance, lactase-deficiency, glucose-galactose-malabsorption or other malabsorption syndromes.
•History of anaphylaxis.
•Active tuberculosis.
•Diagnosed multi-systemic chronic autoimmune diseases.
•Diagnosed chronic disease involving lung (COPD, emphysema, bronchiectasis), heart (i.e. severe hypertension, heart failure, coronary disease), nervous system, thyroid, liver, spleen, kidney.
•Immune deficiency (for example induced by immunosuppressive drugs).
•Malignancy.
•Alcohol abuse as well as drug and/or medication abuse.
•Patients treated with drugs contra-indicated during immunotherapy.
•Contra-indication for adrenalin (subjects who are unable to or would not comply with the use of self-injectable epinephrine or are at a greater risk of developing adverse reactions after its use, or who have a history of self-injectable epinephrine use was ineligible).
•Completed or ongoing long-term treatment with tranquilizer or psycho active drugs.
•Subject who is breast-feeding, pregnant, or intend to become pregnant.
•Subjects who have any clinically significant condition or situation that the investigator judges would interfere with participation or study evaluations