Health Condition 1: J309- Allergic rhinitis, unspecified
Conditions
Interventions
Intervention1: FDC of Bilastine 10 mg plus Montelukast 4 mg Oral Suspension: Patients will be advised to take 5 mL of oral suspension once a day orally one hour before or two hours after meals around
Sponsors
Synokem Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged between 6 and 11 years (both inclusive). 2. Patients with a history of allergic rhinitis, a positive skin prick test to at least one relevant allergen and active symptoms of allergic rhinitis at study entry. 3. Patients with elevated serum IgE levels ( >100 IU/mL) at screening or baseline visit. 4. Patients with Total Nasal Symptom Score (TNSS) at screening or baseline � 4. 5. Written informed assent or oral consent from the patient, legally acceptable representative or parent and able to follow study procedures.
Exclusion criteria
Exclusion criteria: 1. Patients with hypersensitivity to either of the study medications or any of the ingredients of the formulation. 2. Patients with Electrocardiographic abnormalities including conduction delay and an abnormal QTc interval. 3. Patients with upper respiratory tract infections including cold and systemic infections within 3 weeks of baseline/screening visit. 4. Patients with history of renal, hepatic, gastrointestinal tract, cardiovascular, respiratory, haematological, endocrine or neurological diseases. 5. Patients with clinically significant impaired hepatic function [SGOT & SGPT more than 2.5X the UNL]. 6. Patients who had initiation of allergen immunotherapy within previous 6 months. 7. Patients with history of Rhinitis medicamentosa, non-allergic rhinitis or substantial structural nasal obstruction. 8. Patients with history of nasal polyps or any clinically important nasal anomaly. 9. Patients with history of acute and/or chronic sinusitis within 30 days of baseline/screening visit. 10. Patients with history of eye surgery or intranasal surgery within 3 months of baseline/screening visit. 11. Patient with severe asthma requiring emergency room treatment within 1 month or hospitalization within 3 month before the trial. 12. Concurrent participation in another clinical trial or any investigational therapy within 90 days prior to screening visit. 13. Currently taking prohibited medications(s) listed and inability/unwillingness to discontinue them for the entire study period. 14. Suspected inability or unwillingness to comply with the study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in Total Symptom Score [(TSS is the sum Total nasal symptom score (TNSS) and Total Non-Nasal symptom score (TNNSS)] at the end of study as compared to baseline.Timepoint: At Day 1, Day 7 and Day 14. | — |
Secondary
| Measure | Time frame |
|---|---|
| The assessment of safety of patients [comparison of incidence of treatment emergent adverse event (TEAE)].Timepoint: Throughout the study.;The assessment of tolerability of investigational product will be based on incidence of AEs and SAEs and changes in laboratory values.Timepoint: AE & SAE - Throughout the study. Laboratory Values - Day 1 and Day 14.;The change in Total nasal symptom score (TNSS) at the end of study as compared to baseline.Timepoint: At Day 1, Day 7 and Day 14.;The change in Total non-nasal symptom score (TNNSS) at the end of study as compared to baseline.Timepoint: At Day 1, Day 7 and Day 14. | — |
Countries
India
Contacts
Public ContactSurender Kumar Arora
Clinwave Research Pvt. Ltd.
Outcome results
None listed