A Clinical Trial to evaluate Efficacy and Safety of Bilastine Tablet 20 mg Vs. Levocetirizine Tablet 5 mg for the Treatment of Allergic Rhinoconjunctivitis

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2017
INTERVENTION: Intervention1: Bilastine Tablet 20 mg: One Tablet to be taken orally once daily 1 to 2 hours before meal for 28 days Control Intervention1: Levocetirizine Tablet 5 mg: One Tablet to be taken orally once daily 1 to 2 hours before meal for 28 days. CONDITION: Allergic Rhinoconjunctivitis PRIMARY OUTCOME: Mean change in TSS (Total Symptom Score) of Allergic Rhinoconjunctivitis after 28 days treatment with Bilastine Tablets 20 mg Vs. Levocetirizine Tablets 5 mg.‐‐‐‐‐‐Timepoint: Mean change in TSS (Total Symptom Score) of Allergic Rhinoconjunctivitis after 28 days treatment with Bilastine Tablets 20 mg Vs. Levocetirizine Tablets 5 mg. SECONDARY OUTCOME: 1. QOL (Quality of Life) assessed by the RQLQ (Rhinoconjunctivitis Quality of Life Questionnaire‐‐‐‐‐‐Timepoint: Day 7, Day 14, Day 21 and Day 28 INCLUSION CRITERIA: 1. Subjects of both genders with age â?¥ 18 years and â?¤ 65 years. 2. Subjects with total IgE level â?¥75kU/L will be included. 3. Subjects with absolute eosinophil count value of 80 cells/ml will be included. 4. All patients will additionally require to have a minimum reflective Total nasal symptom (TNSS) score and Total Non‐nasal symptoms (Non â?? TNSS) of â?¥ 72 as sum of the six assessments in the last 3 days of the screening period; o Total Nasal Symptoms (TNSS): obstruction, rhinorrhoea, itching and sneezing o Total Non‐nasal symptoms (Non ‐TNSS): ocular itching, lacrimation, itching of ears and/or palate and ocular redness Each of these symptoms will be assessed over the preceding 12 hours, twice daily, graded on a pre‐determined severity scale of 0‐3 to Total nasal symptom (TNSS) score and Total Non‐nasal symptoms (Non â?? TNSS). 5. Freshly diagnosed subject will be included in the study
Epistemonikos ID: a6c14db5865dc7c8231e3545a1f026a5dd407ee1
First added on: Dec 20, 2022