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

Study Overview
=================
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.

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

Conditions
-----------------
Nasal Polyps

Intervention / Treatment
-----------------
* Drug: Mometasone Furoate Nasal Spray
* Drug: Placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mometasone Furoate Nasal Spray (MFNS)<br>MFNS 200 mcg (2 sprays of 50 mcg in each nostril) once daily in the morning | Drug: Mometasone Furoate Nasal Spray<br>* MFNS 200 mcg (2 sprays of 50 mcg in each nostril) once daily in the morning for up to 24 weeks or until relapse<br>* Other names: SCH 032088;|
| Placebo Comparator: Placebo<br>Placebo nasal spray (2 sprays of 50 mcg in each nostril) once daily in the morning | Drug: Placebo<br> <br> * Other names: Placebo (2 sprays of 50 mcg in each nostril) once daily in the morning for up to 24 weeks or until relapse;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
functional, endoscopic, sinus, surgery