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

Phase 3

Completed

• Conditions: Nasal Polyps
• Interventions: Drug: Placebo; Drug: Mometasone Furoate Nasal Spray

• Registration Number: NCT00731185
• Lead Sponsor: Organon and Co

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-09-01
• Primary Completion: 2005-09-01
• Study Completion: 2005-09-01
• Study First Submitted: 2008-08-05
• Study First Submitted QC: 2008-08-07
• Study First Posted: 2008-08-08
• Status Verified: 2022-02
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 162

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo nasal spray (2 sprays of 50 mcg in each nostril) once daily in the morning
Mometasone Furoate Nasal Spray (MFNS)	Mometasone Furoate Nasal Spray	MFNS 200 mcg (2 sprays of 50 mcg in each nostril) once daily in the morning

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Signs and symptom scores	All study visits (up to 24 weeks of treatment)
Adverse events	Throughout the whole study after the Screening period.
Quality of life, peak nasal inspiratory flow, olfaction threshold	Measured starting 1 week after treatment up to 24 weeks of treatment