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

Completed

• Conditions: Acute Rhinosinusitis
• Interventions: Drug: Mometasone Nasal 50 Mcg/Inh Nasal Spray; Device: Nasal spray

• Registration Number: NCT05639959
• Lead Sponsor: Saffron Pharma

Brief Summary

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

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.

Study Timeline

• Study Start: 2022-09-10
• Status Verified: 2022-11
• Primary Completion: 2022-11-06
• Study Completion: 2022-11-06
• Study First Submitted: 2022-11-27
• Study First Submitted QC: 2022-11-27
• Last Update Submitted: 2022-11-27
• Study First Posted: 2022-12-07
• Last Update Posted: 2022-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Children and adults of age (10-50) who had a diagnosis of rhinitis
2. Ability and willingness to understand and provide informed consent.

Exclusion Criteria

1. Known current pregnancy.
2. Current hospitalization.
3. Unable to complete online questionnaires or adhere to study requirements.
4. Kidney failure or dialysis; severe liver disease or cirrhosis.
5. Any parathyroid conditions.
6. Known current pregnancy.
7. History of SARS-CoV-2 infection.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Commercial product group	Nasal spray	group who are taking commercial nasal spray products
New formulation product group	Mometasone Nasal 50 Mcg/Inh Nasal Spray	who are taking new formulation nasal spray product with same strength
New formulation product group	Nasal spray	who are taking new formulation nasal spray product with same strength
Commercial product group	Mometasone Nasal 50 Mcg/Inh Nasal Spray	group who are taking commercial nasal spray products

Primary Outcome Measures

Name	Time	Method
congestion	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.

Trial Locations

Locations (1)

Saffron Pharmaceutical; 🇵🇰 Faisalabad, Punjab, Pakistan