NCT00731185

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2003

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

August 5, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 8, 2008

Completed
Last Updated

August 15, 2024

Status Verified

February 1, 2022

Enrollment Period

2 years

First QC Date

August 5, 2008

Last Update Submit

August 13, 2024

Conditions

Nasal Polyps

Keywords

functionalendoscopicsinussurgery

Outcome Measures

Primary Outcomes (1)

  • Time to relapse in polyp score after surgery

    Assessment for relapse was performed at every study visit (up to 24 weeks of treatment)

Secondary Outcomes (3)

  • Signs and symptom scores

    All study visits (up to 24 weeks of treatment)

  • Quality of life, peak nasal inspiratory flow, olfaction threshold

    Measured starting 1 week after treatment up to 24 weeks of treatment

  • Adverse events

    Throughout the whole study after the Screening period.

Study Arms (2)

Mometasone Furoate Nasal Spray (MFNS)

EXPERIMENTAL

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

Drug: Mometasone Furoate Nasal Spray

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Mometasone Furoate Nasal SprayDRUG

MFNS 200 mcg (2 sprays of 50 mcg in each nostril) once daily in the morning for up to 24 weeks or until relapse

Also known as: Nasonex, SCH 032088
Mometasone Furoate Nasal Spray (MFNS)
PlaceboDRUG
Also known as: Placebo (2 sprays of 50 mcg in each nostril) once daily in the morning for up to 24 weeks or until relapse
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 19289710DERIVED

MeSH Terms

Conditions

Nasal PolypsFistula

Interventions

Mometasone Furoate

Condition Hierarchy (Ancestors)

Nose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2008

First Posted

August 8, 2008

Study Start

September 1, 2003

Primary Completion

September 1, 2005

Study Completion

September 1, 2005

Last Updated

August 15, 2024

Record last verified: 2022-02