Patients: Allergic Rhinitis and allergic rhinoconjunctivitis in patients with seasonal allergy to grass pollen
Conditions
Interventions
Trade Name: 2LALERG
Product Name: Cytokins complexe and SNA®-ALERG Ref "2LALERG"
Pharmaceutical Form: Capsule
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Sublin
Sponsors
Labo'Life
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age =18 years, male and female - Symptomatic since at least two seasons and confirmed by positive skin test and/or the presence of IgE for grasses (prick test defined as positive if higher than or equal to half the negative control; IgE positive if at least class 3 (= 3.5 kU / L); these tests must have been performed at the latest at the first screening visit 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 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: - Patient with an acute exacerbation of allergic rhinitis - Patient with uncontrolled asthma - Immunotherapy received within the last two years - Patient with a known lactose intolerance - Patient taking nasal or bronchial inhaled corticosteroids on a long term basis (intermittent consumption during the season is permitted provided it is mentioned in the patient’s records)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to demonstrate the efficacy of 2L®ALERG versus placebo on the symptoms of allergic rhinitis and allergic rhino-conjunctivitis in patients with seasonal allergy to grass pollen.;Secondary Objective: The secondary objectives will be to compare the effect of 2L®ALERG versus placebo on: -Symptoms of allergy (not corrected by the use of rescue medication), -Use of rescue medication, -Evolution of the quality of life (QoL) using 3 daily specific questions included in the patient’s diary card: Did you sleep well? – Can you work normally? – How do you feel? -Safety (AEs and SAEs). ;Primary end point(s): The primary endpoint will be the area under the curve (AUC) of the overall score established according to the total 5 symptoms score (T5SS) and medication score (MS) according to time from the start of treatment until the end of the patient follow-up. The five symptoms (sneezing, rhinorrhoea, nasal pruritus, eye itching and tearing, and nasal obstruction) will be assessed daily by patients on a scale from 0 (no symptoms) to 3 (severe symptoms) giving a total score ranging from 0 to15. The rescue medications (RM) allowed in the first-line adjuvant treatment will be codified to establish a score. The allowed RM are the oral antihistamines (two points per day of use) or local treatment (nasal or eye; a point per day), and the ocular cromoglycate (one point per day). In case of failure or in case of insufficiency of rescue medications mentioned above, the nasal topical corticosteroids (one point per day of use) will be allowed. ;Timepoint(s) of evaluation of this end point: End of Study: September 2016 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints will be: - Total 5 symptoms score (T5SS) and individual scores of 5 symptoms - Consumption of rescue medications - Evaluation of the QoL: AUC (total score of 3 questions of QoL included in the diary card on the Y-axis, and time on X axis) during the entire follow-up period - Frequency, severity and causality relationship of AEs and SAEs. ;Timepoint(s) of evaluation of this end point: End of Study: September 2016 | — |
Countries
Belgium
Contacts
Public ContactClinical Trial Associate
ECSOR
Outcome results
None listed