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

Completed

• Conditions: Other specified respiratory disorders,

• Registration Number: CTRI/2021/02/031161

Brief Summary

This study is a prospective, Single Arm, Investigator Initiated Study to Evaluate Efficacy and Safety of Bilazest (Bilastine 20mg) Tablets in Adult Patients with Allergic Rhinitis. The rationale of the study is to observe and collect safety and effectiveness data on already approved and marketed Bilazest 20mg tablet containing Bilastine. If found to be successful, will provide an evidence to undertake a large-scale trials to improve long-term health outcomes for individuals with allergic rhinitis. Subjects will complete a screening visit (V1) to determine eligibility for the study based on Inclusion & Exclusion Criteria, medical history and safety measures. Study will be done approximately of 5 weeks (35 days) with 4 weeks (28 days) treatment period and 1 week (7 days) of follow

up period.The Primary Objective is 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 TSS.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-20
• Study Completion: 2022-10-02
• Last Update Posted: 2024-05-30

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

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

• 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.
• 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 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.
• 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 TSS	Change in total symptoms score (TSS) from baseline (Visit 1, D0) to Day 28 ( Visit 3, week 4)

Secondary Outcome Measures

Name	Time	Method
To assess the effect of Bilazest (Bilastine 20 mg) tablet on Quality of life in AR patients	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 evaluate the psychodynamic effects of Bilazest (Bilastine 20 mg) tablet on the CNS by Stanford Sleeping Scale	Change in Stanford sleeping scale scores from pre-dose to 2 hours post-dose on day
To assess the effect of Bilazest (Bilastine 20 mg) tablet on Liver function , kidney function & ECG	Change in the parameters for liver enzymes/ kidney function test/ ECG assessment from baseline to Day 28 (visit 3, week 4)
To assess the safety of Bilazest (Bilastine 20 mg) tablet in relieving the symptoms of allergic rhinitis	Treatment emergent adverse event (TEAEs).
To assess the effect of Bilazest (Bilastine 20 mg) tablet in terms of NSS and NNSS	Change in NSS and NNSS scores from baseline Pre- medication to day 7

Trial Locations

Locations (4)

Bhargava ENT Clinic; 🇮🇳 Mumbai, MAHARASHTRA, India

King Edward Memorial Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Mahatma Gandhi Medical College and Research institute; 🇮🇳 Pondicherry, PONDICHERRY, India

Medstar Speciality Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Bhargava ENT Clinic

🇮🇳Mumbai, MAHARASHTRA, India

Dr Samir K Bhargava

Principal investigator

9820055743

drsamirbhargava@yahoo.co.in