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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00731185

Enrollment

162

Registered

2008-08-08

Start date

2003-09-01

Completion date

2005-09-01

Last updated

2024-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasal Polyps

Keywords

functional, endoscopic, sinus, surgery

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.

Interventions

DRUGMometasone Furoate Nasal Spray

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

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Time to relapse in polyp score after surgery	Assessment for relapse was performed at every study visit (up to 24 weeks of treatment)

Secondary

Measure	Time frame
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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026