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

NCT05639959 | Completed DMC FDA Drug FDA Device

• 1 other identifier: QA/CT/001
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Rhinosinusitis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Commercial product group

group who are taking commercial nasal spray products

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

New formulation product group

who are taking new formulation nasal spray product with same strength

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

Interventions

Mometasone Nasal 50 Mcg/Inh Nasal Spray DRUG

Mometasone furoate nasal spray effectively reduced total and individual symptoms scores in patients with allergic rhinitis.

Also known as: Hivate

Commercial product group; New formulation product group

Nasal spray DEVICE

device can work properly for actuation during trials

Commercial product group; New formulation product group

Eligibility Criteria

• Age: 10 Years - 50 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Saffron Pharma: lead

Study Sites (1)

Saffron Pharmaceutical

Faisalabad, Punjab Province, 38000, Pakistan

Location

MeSH Terms

Interventions

Tobacco Use Cessation Devices

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 3 Weeks
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Yasir Mehmood

Study Record Dates

• First Submitted: November 27, 2022
• First Posted: December 7, 2022
• Study Start: September 10, 2022
• Primary Completion: November 6, 2022
• Study Completion: November 6, 2022
• Last Updated: December 7, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)