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

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 Overview

• Status: Completed
• Conditions: Acute Rhinosinusitis
• Intervention / Treatment: Drug: Mometasone Nasal 50 Mcg/Inh Nasal Spray; Device: Nasal spray

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 Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Faisalabad, Punjab, Pakistan, 38000
      • Saffron Pharmaceutical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Ages Eligible for Study: 10 Years to 50 Years older Sexes Eligible for Study: All Accepts Healthy Volunteers: No Children and adults of any age who had a diagnosis of rhinitis sicca, symptoms of dry nose brought on by the use of specific drugs, or who were receiving concurrent treatment for allergies or rhinosinusitis were eligible for the study

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Saffron Pharma

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2022
• Primary Completion (Actual): November 6, 2022
• Study Completion (Actual): November 6, 2022

Study Registration Dates

• First Submitted: November 27, 2022
• First Submitted That Met QC Criteria: November 27, 2022
• First Posted (Estimate): December 7, 2022

Study Record Updates

• Last Update Posted (Estimate): December 7, 2022
• Last Update Submitted That Met QC Criteria: November 27, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Sinusitis; Anti-Inflammatory Agents; Dermatologic Agents; Anti-Allergic Agents; Mometasone Furoate
• Other Study ID Numbers: QA/CT/001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No