CTRI/2017/06/008889
Completed
Phase 3
A Comparative, Two arm, Randomized, Double blind, Parallel group, Non- Crossover, Multicentric Clinical Study to evaluate Efficacy, Safety and Tolerability of Bilastine Tablet 20 mg as compared with Levocetirizine Tablet 5 mg for the Treatment of Allergic Rhinoconjunctivitis
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Allergic RhinoconjunctivitisHealth Condition 2: H108- Other conjunctivitis
- Sponsor
- Ajanta Pharma Ltd
- Enrollment
- 214
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Subjects of both genders with age \>\= 18 years and \<\= 65 years.
- •2\.Subjects with total IgE level \>\=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 \>\= 72 as sum of the six assessments in the last 3 days of the screening period;
- •oTotal Nasal Symptoms (TNSS): obstruction, rhinorrhoea, itching and sneezing
- •oTotal 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.
- •6\.Patients with Acute Bronchial Asthma will be included in the study (Diagnosed by Spirometry).
- •7\.Female patients of child bearing potential those are non\-pregnant and willing to use effective contraceptive method during participation in the study. If the subject is not already consuming Oral Contraceptives, they should opt for IUCD.
Exclusion Criteria
- •1\.Patients with hypersensitivity to H1\.
- •2\.Patients with H2 antihistamines within 3 days of randomization.
- •3\.Patients with systemic or intranasal corticosteroids within 4 weeks
- •4\.Patients with intranasal and systemic decongestants within 3 days of randomization to treatment will be excluded from the study
- •5\.Patients who had received allergen immunotherapy
- •6\.CNS acting agents (including antidepressants, sedatives, anxiolytics, hypnotics, opioids or neuroleptics) at any time will be also excluded.
- •7\.Patients who had undergone nasal surgery in the previous 6 months and patients with nasal polyps, large adenoids, significant deviation of the nasal septum, acute or chronic sinusitis, any injury or tumor in the nose.
- •8\.Patients with upper respiratory tract infection.
- •9\.Patients with Chronic/ Perennial Asthma
- •10\.Patients who are currently using beta blockers or corticosteroids
Outcomes
Primary Outcomes
Not specified
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