Health Condition 1: J309- Allergic rhinitis, unspecified
Conditions
Interventions
Intervention1: Fixed dose combination of Bilastine 20 mg and Montelukast 10 mg tablets: 1 tablet administered 1 hour before meals or 2 hours after taking meals
Administered Orally, Once daily for 28 d
Sponsors
Hetero Labs Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult male or female patients with age of 18 to 65 years and willing to give written, signed, and dated informed consent to participate in the study 2. Patients with documented and/or clinical history of Allergic Rhinitis (AR), for at least 1 year prior to the study inclusion 3. Patients with moderate to severe baseline 12-hour nasal symptom score 4. Females of childbearing potential who are sexually active must agree to use adequate contraception 5. Clinical laboratory evaluations (including clinical chemistry, hematology, and complete urinalysis) within the reference range
Exclusion criteria
Exclusion criteria: 1. Patients who have non-allergic rhinitis (vasomotor, infectious, drug-induced) 2. Patients who had undergone nasal surgery within the previous 6 months. 3. Patients with nasal polyps, significant deviation of the nasal septum or significant nasal tract structural malformation 4. Patients with a history of acute or chronic sinusitis, asthma or any other condition that can interfere with the aim of the study. 5. Patients with Upper respiratory tract infections within 3 weeks prior to the study 6. Patients planning to travel outside of the study area during the course of the study 7. Patients who will be operating heavy machinery or need to drive motor vehicles as an essential part of their profession 8. Patients with HIV infection, chronic hepatitis B, or hepatitis C Infection 9. Currently participating in another investigational study or has participated in an investigational study within 30 days prior to Screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in mean total symptoms score (TSS)Timepoint: Day 0 (D0) to Day 28 (D28) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in mean individual symptom scoresTimepoint: Day 0 (D0) to Day 7 (D7), Day 14 (D14) and Day 28 (D28);Change in mean nasal symptom score (NSS) and non-nasal symptom score (NNSS)Timepoint: Day 0 (D0) to Day 7 (D7), Day 14 (D14) and Day 28 (D28);Change in mean overall assessment of discomfort due to Allergic rhinitisTimepoint: Day 0 (D0) to Day 14 (D14) and Day 28 (D28);Change in mean total symptoms score (TSS)Timepoint: Day 0 (D0) to Day 7 (D7) and Day 14 (D14);Investigators global clinical impression (CGI)Timepoint: Day 14 (D14) and Day 28 (D28) | — |
Countries
India
Contacts
Public ContactDr SD Sinha
Hetero Labs Limited
Outcome results
None listed