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Mometasone Furoate Nasal Spray for Treatment of Nasal Polyposis After Surgery (Study P03218)

Primary Purpose

Nasal Polyps

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Mometasone Furoate Nasal Spray
Placebo
Sponsored by
Organon and Co
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasal Polyps focused on measuring functional, endoscopic, sinus, surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • At least 18 years of age
  • Bilateral nasal polyps
  • Fulfill criteria for polypectomy (be indicated for surgical - FESS - treatment)

Exclusion Criteria:

  • Polypectomy within the last 6 months
  • Unhealed nasal surgery/trauma
  • >5 previous polypectomies
  • Female of childbearing age who is pregnant, lactating, or not using active contraceptive methods
  • Nasal infection
  • Pulmonary tuberculosis
  • Cystic fibrosis, glaucoma, clinically significant cardiovascular, pulmonary, renal, hepatic, metabolic, hematological, or neurological disease
  • Immunocompromised
  • Rhinitis medicamentosa (rebound congestion following misuse of nasal decongestants)
  • Known hereditary mucociliary dysfunction
  • Significant nasal structure abnormalities
  • Asthmatic attack within the past 30 days
  • Asthmatic patients requiring >1000 mcg beclomethasone or equivalent
  • Asthmatic patients not stable on corticosteroid therapy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Mometasone Furoate Nasal Spray (MFNS)

    Placebo

    Arm Description

    MFNS 200 mcg (2 sprays of 50 mcg in each nostril) once daily in the morning

    Placebo nasal spray (2 sprays of 50 mcg in each nostril) once daily in the morning

    Outcomes

    Primary Outcome Measures

    Time to relapse in polyp score after surgery

    Secondary Outcome Measures

    Signs and symptom scores
    Quality of life, peak nasal inspiratory flow, olfaction threshold
    Adverse events

    Full Information

    First Posted
    August 5, 2008
    Last Updated
    February 7, 2022
    Sponsor
    Organon and Co
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00731185
    Brief Title
    Mometasone Furoate Nasal Spray for Treatment of Nasal Polyposis After Surgery (Study P03218)
    Official Title
    A Multi-center, Randomized, Double-blind, Placebo-controlled Study on Efficacy and Safety of Mometasone Furoate Nasal Spray (MFNS) in the Post Surgical Treatment of Nasal Polyposis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1, 2003 (Actual)
    Primary Completion Date
    September 1, 2005 (Actual)
    Study Completion Date
    September 1, 2005 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Organon and Co

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study was conducted to evaluate the effectiveness of mometasone nasal spray in preventing polyp relapse/symptom worsening in patients after surgical treatment of nasal polyps. Patients who met Screening eligibility underwent endoscopic sino-nasal surgery (FESS) on visit 2. Mometasone nasal spray or placebo was started about 2 weeks after surgery and continued for up to 24 weeks or until relapse.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Nasal Polyps
    Keywords
    functional, endoscopic, sinus, surgery

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    162 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Mometasone Furoate Nasal Spray (MFNS)
    Arm Type
    Experimental
    Arm Description
    MFNS 200 mcg (2 sprays of 50 mcg in each nostril) once daily in the morning
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo nasal spray (2 sprays of 50 mcg in each nostril) once daily in the morning
    Intervention Type
    Drug
    Intervention Name(s)
    Mometasone Furoate Nasal Spray
    Other Intervention Name(s)
    Nasonex, SCH 032088
    Intervention Description
    MFNS 200 mcg (2 sprays of 50 mcg in each nostril) once daily in the morning for up to 24 weeks or until relapse
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Other Intervention Name(s)
    Placebo (2 sprays of 50 mcg in each nostril) once daily in the morning for up to 24 weeks or until relapse
    Primary Outcome Measure Information:
    Title
    Time to relapse in polyp score after surgery
    Time Frame
    Assessment for relapse was performed at every study visit (up to 24 weeks of treatment)
    Secondary Outcome Measure Information:
    Title
    Signs and symptom scores
    Time Frame
    All study visits (up to 24 weeks of treatment)
    Title
    Quality of life, peak nasal inspiratory flow, olfaction threshold
    Time Frame
    Measured starting 1 week after treatment up to 24 weeks of treatment
    Title
    Adverse events
    Time Frame
    Throughout the whole study after the Screening period.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: At least 18 years of age Bilateral nasal polyps Fulfill criteria for polypectomy (be indicated for surgical - FESS - treatment) Exclusion Criteria: Polypectomy within the last 6 months Unhealed nasal surgery/trauma >5 previous polypectomies Female of childbearing age who is pregnant, lactating, or not using active contraceptive methods Nasal infection Pulmonary tuberculosis Cystic fibrosis, glaucoma, clinically significant cardiovascular, pulmonary, renal, hepatic, metabolic, hematological, or neurological disease Immunocompromised Rhinitis medicamentosa (rebound congestion following misuse of nasal decongestants) Known hereditary mucociliary dysfunction Significant nasal structure abnormalities Asthmatic attack within the past 30 days Asthmatic patients requiring >1000 mcg beclomethasone or equivalent Asthmatic patients not stable on corticosteroid therapy

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19289710
    Citation
    Stjarne P, Olsson P, Alenius M. Use of mometasone furoate to prevent polyp relapse after endoscopic sinus surgery. Arch Otolaryngol Head Neck Surg. 2009 Mar;135(3):296-302. doi: 10.1001/archoto.2009.2.
    Results Reference
    derived
    Available IPD and Supporting Information:
    Available IPD/Information Type
    CSR Synopsis
    Available IPD/Information URL
    http://www.merck.com/clinical-trials/policies-perspectives.html

    Learn more about this trial

    Mometasone Furoate Nasal Spray for Treatment of Nasal Polyposis After Surgery (Study P03218)

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