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

Saffron Pharma

Status: Completed

Conditions: Acute Rhinosinusitis

Treatments: Device: Nasal spray; Drug: Mometasone Nasal 50 Mcg/Inh Nasal Spray

Study type: Observational

Funder types: Industry

Identifiers

NCT05639959

QA/CT/001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 10 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

20 participants in 2 patient groups

Commercial product group

Description:

group who are taking commercial nasal spray products

Treatment:

Drug: Mometasone Nasal 50 Mcg/Inh Nasal Spray

Device: Nasal spray

New formulation product group

Description:

who are taking new formulation nasal spray product with same strength

Treatment:

Drug: Mometasone Nasal 50 Mcg/Inh Nasal Spray

Device: Nasal spray