Efficacy and Safety of New Mometasone Furoate Nasal Spray Formulation in Acute Rhinosinusitis Patients: A Randomized Clinical Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy and Safety of New Mometasone Furoate Nasal Spray Formulation in Acute Rhinosinusitis Patients: A Randomized Clinical Trial

Conditions
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Acute Rhinosinusitis

Intervention / Treatment
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* Drug: Mometasone Nasal 50 Mcg/Inh Nasal Spray
* Device: Nasal spray


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children and adults of age (10-50) who had a diagnosis of rhinitis Ability and willingness to understand and provide informed consent. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Commercial product group<br>group who are taking commercial nasal spray products | Drug: Mometasone Nasal 50 Mcg/Inh Nasal Spray<br>* Mometasone furoate nasal spray effectively reduced total and individual symptoms scores in patients with allergic rhinitis.<br>* Other names: Hivate;Device: Nasal spray<br>* device can work properly for actuation during trials<br>|
| New formulation product group<br>who are taking new formulation nasal spray product with same strength | Drug: Mometasone Nasal 50 Mcg/Inh Nasal Spray<br>* Mometasone furoate nasal spray effectively reduced total and individual symptoms scores in patients with allergic rhinitis.<br>* Other names: Hivate;Device: Nasal spray<br>* device can work properly for actuation during trials<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| congestion | 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. | 3 weeks |