Health Condition 1: null- Allergic Rhinitis classified according to the International guidelines of ARIA
Conditions
Interventions
Intervention1: Fixed dose combination of Ebastine & Montelukast: Ebastine is a 2nd generation anti-histaminic used in the treatment of allergic rhinitis. Montelukast is a leukotriene receptor antagoni
Sponsors
Micro Labs Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Males and females of 12 â?? 65 years (inclusive) 2. Diagnosis of mild and moderate-severe persistent allergic rhinitis ( >= 4 days per week AND >= 4 weeks) 3. Able to provide informed consent to participate in the study (If minor [ 4. Ability to understand study procedures and to comply with them for the entire length of the study including able to record symptom scores in a diary (literate patients). 5. TSS baseline score of at least 5 after mean of 3 scores (based on investigator assessment) 6. Treatment naive for current episode of allergic rhinitis [If patient has already consumed more than 3 daysâ?? doses of oral antihistamines for the current episode, then a wash-out of about 6-7 days to be given before administering study medication based on investigator discretion and patient willingness; if the patient consumes 1-2 doses of OTC cold medications for symptomatic relief, washout is not given.]
Exclusion criteria
Exclusion criteria: 1. Asthma patients 2. Subjects with a current history of frequent, clinically significant sinusitis or chronic purulent postnasal drip. 3. Subjects who, in the opinion of the investigator, are dependent on nasal, oral or ocular decongestants, nasal topical antihistamines or nasal steroids. 4. Any illness requiring steroid by any route. 5. Urticaria, Vasomotor rhinitis, Rhinitis medicamentosa. 6. Subjects who have, in the opinion of the investigator or designee, clinically significant nasal structural abnormalities, including large nasal polyps or marked septum deviation, that significantly interferes with nasal air flow. 7. Pregnancy or lactation. 8. Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements. 9. Use of any other investigational drug in the last 90 days. 10. Subjects known to have an idiosyncratic reaction to any of the ingredients in IMP. 11. Subject with clinically significant abnormal vital sign or laboratory value that precludes participation. 12. Subjects with current evidence of clinically significant hematopoietic, cardiovascular, hepatic, renal, neurologic, psychiatric, autoimmune disease, or other disease that preclude the subjects participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Objective: To compare the efficacy of Ebastine 10 mg plus Montelukast 10 mg with Ebastine 10 mg in decreasing the symptoms of allergic rhinitis for the first two weeks Primary efficacy endpoint: Change from baseline in the Total Symptom Score to the end of first two weeks of treatmentTimepoint: 2 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Objective: To compare safety of Ebastine 10 mg plus Montelukast 10 mg with Ebastine 10 mg when used for treatment of allergic rhinitis for 6 wks Secondary efficacy endpoints: Rhinoconjuctivitis QOL scale Comparing sedation between 2 groups using VAS Safety endpoint: Comparison of safety parameters between Ebastine 10 mg plus Montelukast 10 mg and Ebastine 10 mg using lab parameters and adverse event profile as volunteered by patients and evaluated by the investigatorTimepoint: 6 weeks | — |
Countries
India
Contacts
Public ContactL Manjunath Reddy
Micro Labs Limited
Outcome results
None listed