Clincosm LogoSign in Get a demo

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

Sponsor
Saffron Pharma (Industry)
Overall Status
Completed
CT.gov ID
NCT05639959
Collaborator
(none)
20
Enrollment
1
Location
1.9
Actual Duration (Months)
10.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
20 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Efficacy and Safety of New Mometasone Furoate Nasal Spray Formulation in Acute Rhinosinusitis Patients: A Randomized Clinical Trial
Actual Study Start Date :
Sep 10, 2022
Actual Primary Completion Date :
Nov 6, 2022
Actual Study Completion Date :
Nov 6, 2022

Arms and Interventions

Arm 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

    Outcome Measures

    Primary Outcome Measures

    1. congestion [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    10 Years to 50 Years
    Sexes Eligible for Study:
    All
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Saffron Pharmaceutical Faisalabad Punjab Pakistan 38000

    Sponsors and Collaborators

    • Saffron Pharma

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yasir Mehmood Mehmood, Dr Yasir Mehmood, Saffron Pharma
    ClinicalTrials.gov Identifier:
    NCT05639959
    Other Study ID Numbers:
    • QA/CT/001
    First Posted:
    Dec 7, 2022
    Last Update Posted:
    Dec 7, 2022
    Last Verified:
    Nov 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Sinusitis
    Mometasone Furoate

    Study Results

    No Results Posted as of Dec 7, 2022