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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05639959
Enrollment
20
Registered
2022-12-07
Start date
2022-09-10
Completion date
2022-11-06
Last updated
2022-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Rhinosinusitis

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.

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.

Interventions

DRUGMometasone Nasal 50 Mcg/Inh Nasal Spray

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

device can work properly for actuation during trials

Sponsors

Saffron Pharma
Lead SponsorINDUSTRY

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
10 Years to 50 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
congestion3 weeksThe 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.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026