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.

Completed

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Key information

Conditions

Acute Rhinosinusitis

Age range

10 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Saffron Pharmaceutical

Faisalabad, Punjab Province, 38000, Pakistan

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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.

Treatment and study plan

Mometasone Nasal 50 Mcg/Inh Nasal Spray

Drug

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

Other names: Hivate

nasal spray

Device

device can work properly for actuation during trials

Primary outcomes

congestion

Time frame: 3 weeks

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.

Sponsors and collaborators

Lead sponsor

Saffron Pharma

Industry

Registry information

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2022
First posted: Dec 7, 2022
Registry last updated: Dec 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed