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

Organon

Status and phase

Completed

Phase 3

Conditions

Nasal Polyps

Treatments

Drug: Mometasone Furoate Nasal Spray

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00731185

P03218

Details and patient eligibility

About

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.

Enrollment

162 patients

Sex

All

Ages

18+ years old

Volunteers

No 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