A clinical study of combination of Bilastine plus Montelukast in Patients with Allergic Rhinitis to know its effectiveness and side effects

Phase 3

Completed

• Conditions: Allergic rhinitis due to pollen,

• Registration Number: CTRI/2019/10/021567
• Lead Sponsor: Synokem Pharmaceuticals Ltd

Brief Summary

Thistrial is a multicentric, randomized, double blind,parallel group, comparative, phase III clinical study to evaluate the efficacy,safety and tolerability of FDC of Bilastine 20 mg plus Montelukast 10 mg TabletsVersus FDC of Levocetirizine 5 mg plus Montelukast 10 mg Tablets in patients withallergic rhinitis.

 After confirmingthe inclusion/exclusion criteria the subject will be randomized and providedwith study medication at randomization visit. Subjects will be provided with patientdiary at randomization visit, which need to be brought along with in eachsubsequent visit till the last visit. Follow up visits will be done on week 1/day7(±1), week 2/day 14(±1) and week 4/day 28(±2) (Final Visit) of treatment toassess efficacy, safety and tolerability.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-10
• Study Completion: 2019-12-28
• Last Update Posted: 2021-06-24

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

• Male or female patients aged between 18 and 65 years (both inclusive).
• 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.
• Patients with Total Nasal Symptom Score (TNSS) at baseline ≥ 4.
• Baseline TNSS will be defined as the mean of the 6 last assessments of the patient’s diary (3 last days before randomization).
• Patients with ability to understand and provide written informed consent form, which must have been obtained prior to screening.
• Patients willing to comply with the protocol requirements.

Exclusion Criteria

• Patients with hypersensitivity to either of the study medications or any of the ingredients of the formulation.
• Has clinical laboratory evaluations (including biochemistry and hematology) are not within the reference range for the testing laboratory and the results are deemed clinically significant by the investigator.
• Patients with Electrocardiographic abnormalities including conduction delay and an abnormal QTc interval.
• Patients with clinically significant impaired hepatic function.
• [SGOT & SGPT more than 2.5X the UNL and/or Total bilirubin more than 1.5X the UNL].
• Patients with abnormal eGFR (<60 mL/min/1.73 m2).
• Patients with Type 1 diabetes & Type 2 diabetes mellitus whose diabetes has not been stable and controlled for the previous three months and with HbA1c value greater than 8%.
• Female patients who are pregnant or lactating or planning to become pregnant during the study period.
• Females who are not ready to use acceptable contraceptive methods during the course of study.
• Patients with upper respiratory tract infections including cold and systemic infections within 3 weeks of baseline/screening visit.
• Patients who had initiation of allergen immunotherapy within previous 6 months.
• Patients with history of Rhinitis medicamentosa, non-allergic rhinitis or substantial structural nasal obstruction.
• Patients with the presence of nasal polyps or any clinically important nasal anomaly.
• Patients with the history of eye surgery or intranasal surgery within 3 months of baseline/screening visit.
• Patient with severe asthma requiring emergency room treatment within 1 month or hospitalization within 3 month before the trial.
• Patients with known case of HIV, Hepatitis B & C.
• Patients with medical history of Oncological Conditions since last 5 years.
• Patients with current evidence of clinically significant hematopoietic, cardiovascular, hepatic renal, neurologic, psychiatric, autoimmune disease, or other disease that precludes the patient’s participation in the study.
• Concurrent participation in another clinical trial or any investigational therapy within 90 days prior to signing informed consent.
• Currently taking prohibited medications(s) listed and inability/unwillingness to discontinue them for the entire study period.
• Suspected inability or unwillingness to comply with the study procedures.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	At Day 7, Day 14 & Day 28

Secondary Outcome Measures

Name	Time	Method
The change in Total nasal symptom score (TNSS) at the end of study as compared to baseline.	At Day 7, Day 14 & Day 28
The change in Total non-nasal symptom score (TNNSS) at the end of study as compared to baseline.	At Day 7, Day 14 & Day 28

Trial Locations

Locations (6)

Down Town Hospital Ltd.; 🇮🇳 Kamrup, ASSAM, India

Gandhi Medical College / Hospital; 🇮🇳 Hyderabad, TELANGANA, India

Government Medical College & Govt. General Hospital (Old RIMSGGH); 🇮🇳 Srikakulam, ANDHRA PRADESH, India

GSVM Medical College; 🇮🇳 Nagar, UTTAR PRADESH, India

Maharaja Agrasen Superspeciality Hospital; 🇮🇳 Jaipur, RAJASTHAN, India

Redkar Hospital and Research Centre; 🇮🇳 Goa, GOA, India

Down Town Hospital Ltd.

🇮🇳Kamrup, ASSAM, India

Dr Swapnav Borthakur

Principal investigator

9864038704

swapnav.borthakur@gmail.com