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

Organon and Co162 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

162

Conditions

Nasal Polyps

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

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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 Outcomes

Signs and symptom scores

Time frame: All study visits (up to 24 weeks of treatment)

Quality of life, peak nasal inspiratory flow, olfaction threshold

Time frame: Measured starting 1 week after treatment up to 24 weeks of treatment

Adverse events

Time frame: Throughout the whole study after the Screening period.

Data from ClinicalTrials.gov

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