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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-10

Study Completion Date

2022-11-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effectiveness of Mometasone Nasal Irrigation for Chronic Rhinosinusitis

NCT03705793

Chronic Rhinosinusitis (Diagnosis) Allergic Rhinosinusitis Chronic Eosinophilic Rhinosinusitis

COMPLETED PHASE4

Comparison of Daily Mometasone Furoate Nasal Spray Alone Versus a Combination With Montelukast for Treatment of Chronic Rhinosinusitis With Asthma After Functional Endoscopic Sinus Surgery

NCT02110654

Sinusitis Nasal Polyps Asthma

COMPLETED PHASE4

Efficacy and Safety of Mometasone Furoate Nasal Spray in Children With Adenoid Hypertrophy. SNORE Study (P05155)

NCT00552032

Adenoids Hypertrophy

COMPLETED PHASE3

A Study of the Effectiveness and Safety of Mometasone Furoate Nasal Spray (MFNS, SCH 032088) for the Treatment of Nasal Polyps (P05604)

NCT01386125

Nasal Polyps

COMPLETED PHASE3

Effectiveness and Safety of Once or Twice Daily Mometasone Nasal Spray Versus Amoxicillin Versus Placebo for Treatment of Acute Rhinosinusitis (Phase 3 Study)(Study P02692)

NCT00751075

Acute Rhinosinusitis

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Rhinosinusitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Commercial product group

group who are taking commercial nasal spray products

Mometasone Nasal 50 Mcg/Inh Nasal Spray

Intervention Type DRUG

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

Nasal spray

Intervention Type DEVICE

device can work properly for actuation during trials

New formulation product group

who are taking new formulation nasal spray product with same strength

Mometasone Nasal 50 Mcg/Inh Nasal Spray

Intervention Type DRUG

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

Nasal spray

Intervention Type DEVICE

device can work properly for actuation during trials

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mometasone Nasal 50 Mcg/Inh Nasal Spray

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

Intervention Type DRUG

Nasal spray

device can work properly for actuation during trials

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Hivate

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

10 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No