Health Condition 1: J988- Other specified respiratory disorders
Conditions
Interventions
None listed
Sponsors
NIL
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient willing and able to sign informed consent form. 2. Male & female patient between age group 18 years - 60 years 3. Patient with clinical history and presenting symptoms of Allergic Rhinitis who have not taken any medications for at least 2 weeks 4. Patient with no allergies to any of the ingredients of the study drug as per PI’s discretion 5. Patient willing to follow the protocols requirements
Exclusion criteria
Exclusion criteria: 1. Patient having hypersensitivity to Bilastine or any excipients of IP as per PI’s discretion 2. Patient with nasal polyps and deviation of the nasal septum or significant nasal tract structural malformation 3. Patient taking H1 or H2 antihistamines within 3 days to one week 4. Patient with acute or chronic sinusitis within 30 days of visit 1 5. Patient with a history of hypersensitivity to antihistamines, imidazole’s or lactose. 6. Patient taking corticosteroids during the last 4 weeks; loratadine or desloratadine during the last 10 days; anti-leukotrienes or ketotifen during the last 2 weeks; macrolides, imidazole, anticholinergics or decongestants during the last 3days; or immunotherapy within 2 years (unless taking a stable maintenance dose for 1 month) before entry into the study, any CNS acting agents including antidepressants,sedatives,anxiolytic,hypnotics, opioids or neuroleptics at any time 7. Patient with a history of alcohol and drug abuse 8. Patient with a history of smoking or tobacco use 9. Patient with any clinically significant condition (cardiovascular, neurological, upper respiratory tract infection or acute/chronic pulmonary disorder, severe asthma or malignant diseases) 10. Pregnant or nursing women 11. Patient who had participated in another trial within the previous 3 months 12. Patient with non-allergic rhinitis with different causes. 13. History of intranasal / eye surgeries within 3 months of Visit 1 14. Patient suffering from any other psychiatric illness or any other chronic disease which would interfere with trail assessments as per PI’s discretion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the effectiveness of Bilazest (Bilastine 20 mg) tablet, in relieving the symptoms of allergic rhinitis in different geographical locations of India in terms of TSSTimepoint: Change in total symptoms score (TSS) from baseline (Visit 1, D0) to Day 28 ( Visit 3, week 4) | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the effect of Bilazest (Bilastine 20 mg) tablet in terms of NSS and NNSSTimepoint: Change in NSS and NNSS scores from baseline Pre- medication to day 7 (intermediate visit) and day 28 (visit 3, week 4);To assess the effect of Bilazest (Bilastine 20 mg) tablet on Liver function , kidney function & ECGTimepoint: Change in the parameters for liver enzymes/ kidney function test/ ECG assessment from baseline to Day 28 (visit 3, week 4);To assess the effect of Bilazest (Bilastine 20 mg) tablet on Quality of life in AR patientsTimepoint: QOL assessed by the change in RQLQ (Rhino conjunctivitis quality of life questionnaire scores) from baseline (visit 1, Day 0) to day 7 (intermediate visit) and day 28 (visit 3, week 4);To assess the safety of Bilazest (Bilastine 20 mg) tablet in relieving the symptoms of allergic rhinitisTimepoint: Treatment emergent adverse event (TEAEs).;To evaluate the psychodynamic effects of Bilazest (Bilastine 20 mg) tablet on the CNS by Stanford Sleeping ScaleTimepoint: Change in Stanford sleeping scale scores from pre-dose to 2 hours post-dose on day 0 (baseline visit) | — |
Countries
India
Contacts
Public ContactMr Vairamuthu Ammaiyappam
IDD Research Solutions Pvt Ltd
Outcome results
None listed