Investigator Initiated Study to Evaluate Effect and safety of Bilazest (Bilastine 20mg) Tablets in Adult Patients with Allergic Rhinitis

Not Applicable

Completed

• Conditions: Health Condition 1: J988- Other specified respiratory disorders

• Registration Number: CTRI/2021/02/031161
• Lead Sponsor: I

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2022-02-10
• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 90

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

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

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)