An Open labeled phase IV clinical trial to assess the safety and tolerability of Ebastine (10 mg) and Phenylephrine (10 mg) FDC as short duration therapy, in patients with allergic rhinitis

Sterling Lab0 个研究点目标入组 145 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. Diagnosis of mild and moderate-severe intermittent allergic rhinitis ( <= 4 days per week AND <= 4 weeks)
•2. Able to provide informed consent to participate in the study
•3. 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).
•4. TSS baseline score of at least 5 both on screening and randomization day (based on investigator assessment)
•5. Treatment naive for current episode of allergic rhinitis [if patient has already consumed any medication for the current episode, then a wash-out of about 6-7 days to be given before administering study medication

•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

发起方

Sterling Lab