A parallel group, randomized, double blind, multicentric, active controlled, phase III study comparing the safety and efficacy of Ebastine 10 mg with Montelukast 10 mg versus Ebastine 10mg in allergic rhinitis

Micro Labs Limited0 个研究点目标入组 541 人开始时间: 待定最近更新: 2021年11月24日

研究概览

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•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 [ <18 years, consent from parent/legally authorized representative must also to be obtained in addition to the consent from the patient)
•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.]

•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

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