NCT05639959

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: Saffron Pharma · Industry
• Sex: All
• Age: 10 Years – 50 Years
• Healthy volunteers: —

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.

Conditions

• Acute Rhinosinusitis

Interventions

Type	Name	Description
DRUG	Mometasone Nasal 50 Mcg/Inh Nasal Spray	Mometasone furoate nasal spray effectively reduced total and individual symptoms scores in patients with allergic rhinitis.
DEVICE	Nasal spray	device can work properly for actuation during trials

Timeline

• Start date: 2022-09-10
• Primary completion: 2022-11-06
• Completion: 2022-11-06
• First posted: 2022-12-07
• Last updated: 2022-12-07

Locations

1 site across 1 country: Pakistan

Regulatory

• FDA-regulated drug study
• FDA-regulated device study