A clinical study to assess the effect of Bilastine and Montelukast Tablets for the treatment of allergic rhinitis patients.
- Conditions
- Health Condition 1: J301- Allergic rhinitis due to pollen
- Registration Number
- CTRI/2023/10/058571
- Lead Sponsor
- Exemed Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
1. Male or female patients aged between 18 and 65 years (both inclusive).
2. Patients with a history of allergic rhinitis, a positive skin prick test or radio allegro sorbent test (RAST) to at least one relevant allergen and active symptoms of allergic rhinitis at screening or baseline visit.
3. Patients with visual analogue scale (VAS) score of 5 or more for total nasal symptoms and/or severe ocular symptoms at screening or baseline visit.
4. Women of childbearing potential (WOCBP) must be using an acceptable method of contraception to avoid pregnancy throughout the study. WOCBP must have a negative urine pregnancy test at screening / baseline visit.
5. Patients with ability to understand and provide written, dated and signed informed consent form, which must have been obtained prior to screening.
6. Patients willing to comply with all the protocol requirements.
1. Patients with hypersensitivity to either of the study medications or any of the ingredients of the formulation.
2. Patients with electrocardiographic abnormalities including conduction delay and an abnormal QTc interval.
3. Patients with upper respiratory tract infections including cold and systemic infections within 3 weeks of baseline or screening visit.
4. Patients with history of renal, hepatic, gastrointestinal tract, cardiovascular, respiratory, haematological, endocrine or neurological diseases.
5. Patients with clinically significant impaired hepatic function (SGOT and SGPT more than 2.5X the UNL) or renal dysfunction (serum creatinine = 2.5 mg/dL).
6. Patients who had initiation of allergen immunotherapy within previous 6 months.
7. Patients with history of rhinitis medicamentosa, non-allergic rhinitis or substantial structural nasal obstruction.
8. Patients with history of nasal polyps or any clinically important nasal anomaly.
9. Patients with history of acute and/or chronic sinusitis within 30 days of baseline or screening visit.
10. Patients with history of eye surgery or intranasal surgery within 3 months of baseline or screening visit.
11. Patient with severe asthma requiring emergency room treatment within 1 month or hospitalization within 3 months before the trial.
12. Female patients who are pregnant or breast-feeding or expecting to conceive within the projected duration of the study.
13. Female patients who are of childbearing potential and who are neither surgically sterilized nor willing to use reliable contraceptive methods (like hormonal, barrier methods or intrauterine device).
14. Patients with uncontrolled hypertension with sitting systolic BP = 160 mmHg and/or diastolic BP = 100 mmHg at screening.
15. Patients with a history of any malignancy.
16. Patients with known case of infection with hepatitis B, hepatitis C or HIV.
17. Patients with concurrent participation in another clinical trial or any investigational therapy within 30 days prior to screening visit.
18. Patients currently taking prohibited medications(s) listed and inability/unwillingness to discontinue them for the entire study period.
19. Suspected inability or unwillingness to comply with the study procedures.
20. Patients with any condition which, in the judgment of the Investigator, may render the patient unable to complete the study or which may pose a significant risk to the patient.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean change in visual analogue scale (VAS) score from baseline to end of the study visit for total nasal symptoms.Timepoint: At Baseline Visit (Visit 1) and <br/ ><br>End of the Study Visit (Visit 5 / Day 28).
- Secondary Outcome Measures
Name Time Method Adverse events & serious adverse events <br/ ><br>reported during the study.Timepoint: Throughout the study.;Changes in clinical laboratory parameters from baseline to end of the study visit.Timepoint: At Baseline Visit (Visit 1) and <br/ ><br>End of the Study Visit (Visit 5 / Day 28).;Mean change in total nasal symptom score (TNSS) from baseline to end of the study visit.Timepoint: At Baseline Visit (Visit 1) and <br/ ><br>End of the Study Visit (Visit 5 / Day 28).;Mean change in total symptom score [TSS is the sum of total nasal symptom score (TNSS) and total non-nasal symptom score (TNNSS)] from baseline to end of the study visit.Timepoint: At Baseline Visit (Visit 1) and <br/ ><br>End of the Study Visit (Visit 5 / Day 28).;Mean change in total non-nasal symptom score (TNNSS) from baseline to end of the study visit.Timepoint: At Baseline Visit (Visit 1) and <br/ ><br>End of the Study Visit (Visit 5 / Day 28).