CTRI/2022/03/040760尚未招募3 期
A Multicenter, Randomized, Double-Blind, Active Controlled,Parallel-Group, Comparative,Phase III Clinical Study to Evaluate the Efficacy and Safety of FDC of Bilastine 10 mg plus Montelukast 4 mg orodispersible Tablets versus Bilastine 10 mg orodispersible Tablet and Montelukast 4 mg orodispersible Tablet monotherapy for the Treatment of Allergic Rhinitis.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
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. Male and female subjects between 6 to 12 years of age (both inclusive).
- •2.Subjects with symptoms of allergic rhinitis characterized by nasal congestion, rhinorrhoea, pruritus and sneezing.
- •3. Subjects with total IgE level >=75kU/L will be included.
- •4. Subjects having at least mild-to-moderate daytime nasal symptoms (namely, a minimum predefined 3-day cumulative score of 18 on the subject diary) before randomization.
- •5. Subjects who voluntarily give, IEC/IRB approved, signed written informed assent form and, the parent or legal guardian give signed informed consent form, as appropriate, to participate in this clinical investigation.
- •6. Subjects, and the parent or legal guardian, shall be willing and able to understand
- •and comply with the requirements of the study, administer the medication as instructed, return for the required treatment period visits, comply with therapy prohibitions, and be able to complete the study.
- •7. Subjects shall be in good health and free from any clinically significant disease, other than allergic rhinitis, that might interfere with the study evaluations.
- •8. Subjects willing to refrain from use of all other anti-allergic medications during the
- •14-day treatment period.
排除标准
- •1. Subjects with upper respiratory tract infections within 4 weeks prior to study entry.
- •2.Subjects with rhinitis related to anatomic problems (nasal polyps, large adenoids,significant deviation of the nasal septum, any injury or tumor in the nose etc).
- •3.Subjects with nasal surgery within 3 months prior to study entry.
- •4. Subjects with severe physical nasal obstruction or injury, nasal ulcers, asthma, rhinitis medicamentosa, congestive rhinitis, atrophic rhinitis, acute or chronic sinusitis, sinusitis with purulent nasal discharge, glaucoma, cataract, any psychiatric disorder, and bacterial or viral infection within 2 weeks of participation
- •in the study.
- •5. Subjects receiving astemizole within 3 months; oral or parenteral corticosteroids within 1 month; nasal or ophthalmic corticosteroids within 2 weeks; cetirizine, zafirlukast, oral or long-acting inhaled β-adrenergic agonists or inhaled anticholinergic agents within 1 week; terfenadine, loratadine, or fexofenadine
- •within 72 hours; oral or topical H1-receptor antagonists within 48 hrs; and short-acting antihistamines and decongestants within 24 hours prior to screening.
- •6.Subjects receiving antipruritic agents, NSAIDs and cold remedies within 3 days prior to the study entry.
- •7. Subjects with congestive heart failure, liver diseases, such as cirrhosis or chronic active hepatitis or cerebrovascular disorder within 3 months before informed consent.
- •8. Subjects with abnormal Liver Function Test with values more than 2.5 times the upper limit of normal.
- •9. Subjects with known case of Oncological Conditions.
- •10. Subjects with history of infection with HIV, Hepatitis B virus or Hepatitis C virus.
- •11. Subject with any clinically significant laboratory abnormalities at screening visit.
- •12. Suspected hypersensitivity to either of the study medications or any of the ingredients of the formulation.
- •13. Subjects with any other medical condition that might adversely impact the safety of the study participants or confound the study results.
- •14. Subjects having any condition that would compromise compliance with this protocol.
- •15. Subjects who have been treated with an investigational drug or investigational
- •device within a period of 4 weeks prior to study entry.
- •16. Currently taking prohibited concomitant medications(s) listed and inability/unwillingness to discontinue them for the entire study period.
- •17. Suspected inability or unwillingness to comply with the study procedures.
研究者
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