Efficacy and Safety of New Mometasone Furoate Nasal Spray Formulation in Acute Rhinosinusitis Patients: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- congestion
研究概览
简要总结
Seasonal and perennial allergic rhinitis, acute rhino sinusitis, and nasal polyposis are examples of common inflammatory disorders of the airway that significantly reduce patient health and quality of life. Intranasal corticosteroids are advised as part of treatment plans for each of these illnesses since they help to reduce inflammation and thus symptoms.
Objective In order to assess the effectiveness and safety of a new nano formulation of Mometasone furoate nano-nasal spray (FM-NNS) for the treatment of allergic rhinitis. Mometasone Furoate Nano-nasal spray (FM-NNS) was compared with commercial available nasal spray named as MFNS.
详细描述
Background Seasonal and perennial allergic rhinitis, acute rhino sinusitis, and nasal polyposis are examples of common inflammatory disorders of the airway that significantly reduce patient health and quality of life. Intranasal corticosteroids are advised as part of treatment plans for each of these illnesses since they help to reduce inflammation and thus symptoms.
Objective In order to assess the effectiveness and safety of a new nano formulation of Mometasone furoate nano-nasal spray (FM-NNS) for the treatment of allergic rhinitis. Mometasone Furoate Nano-nasal spray (FM-NNS) was compared with commercial available nasal spray named as MFNS.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 10 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children and adults of age (10-50) who had a diagnosis of rhinitis
- •Ability and willingness to understand and provide informed consent.
排除标准
- •Known current pregnancy.
- •Current hospitalization.
- •Unable to complete online questionnaires or adhere to study requirements.
- •Kidney failure or dialysis; severe liver disease or cirrhosis.
- •Any parathyroid conditions.
- •Known current pregnancy.
- •History of SARS-CoV-2 infection.
研究组 & 干预措施
Commercial product group
group who are taking commercial nasal spray products
干预措施: Mometasone Nasal 50 Mcg/Inh Nasal Spray (Drug)
Commercial product group
group who are taking commercial nasal spray products
干预措施: Nasal spray (Device)
New formulation product group
who are taking new formulation nasal spray product with same strength
干预措施: Mometasone Nasal 50 Mcg/Inh Nasal Spray (Drug)
New formulation product group
who are taking new formulation nasal spray product with same strength
干预措施: Nasal spray (Device)
结局指标
主要结局
congestion
时间窗: 3 weeks
The primary end outcomes were change from baseline in the subject's congestion and/or blockage score averaged throughout the first month of treatment and change from baseline in the physician's assessment of Allergic rhinitis.
次要结局
未报告次要终点
研究者
Yasir Mehmood Mehmood
Dr Yasir Mehmood
Saffron Pharma