CTRI/2014/02/004439已完成3 期
A randomized, single blind, comparative, three way crossover clinical studyto evaluate the efficacy and safety of a novel nasal spray (FDC of Azelastine hydrochloride and Mometasone furoatemonohydrate) compared to its individual components Azelastinehydrochloride 137 mcg and Mometasone furoate monohydrate 50 mcgnasal sprays in patients suffering from perennial Allergic Rhinitis.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Cipla Ltd
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. An Ethics committee approved Informed Consent Form signed and
- •dated by subject and or LAR before screening procedures.
- •2. Subjects of either sexes between 18 and 55 years of age with at least
- •1 positive response to air allergen in skin prick test at screening and a
- •history of perennial allergic rhinitis.
- •3. Subjects presenting with moderate to severe symptoms of perennial
- •allergic rhinitis (nasal and/or ocular)
- •4. In the opinion of the investigator, subject able to comply with
- •requirements of Protocol.
排除标准
- •1. Subjects with history of severe physical nasal obstruction or injury,
- •nasal ulcers, nasal polyps, significant deviated nasal septum, recent
- •nasal surgery, asthma, COPD, rhinitis medicamentosa, acute or
- •chronic sinusitis, glaucoma, cataract, any psychiatric disorder,
- •adrenal insufficiency and contact lens wearers.
- •2. Subjects with bacterial, viral or fungal infection within 2 weeks prior to
- •screening visit.
- •3. Subjects with known hypersensitivity to all study medicines
- •4. Subjects with history of alcohol or drug abuse
- •5. Subjects who have participated in clinical trial in past 30 days
- •6. Pregnant or lactating mothers or planning to become pregnant
- •7. Any clinically significant lab values as per investigators discretion
- •8. Subjects suffering from significant uncontrolled disease of any body
- •9. Use of anti-allergic immunotherapy or biologicals within past 2 years
研究者
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