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

Acute Rhinosinusitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05639959
• Other study ID #: QA/CT/001
• Status: Completed
• Start date: September 10, 2022
• Est. completion date: November 6, 2022

Study information

• Verified date: November 2022
• Source: Saffron Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 6, 2022
• Est. primary completion date: November 6, 2022
• Gender: All
• Age group: 10 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Rhinosinusitis
• Sinusitis

Intervention

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

Locations

Country	Name	City	State
Pakistan	Saffron Pharmaceutical	Faisalabad	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Saffron Pharma

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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