None listed
Conditions
Interventions
Mometasone Furoate in Nasal Spray Type of group
Subjects will receive 200 mg QD Mometasone Furoate in Nasal Spray for 4 months and will be evaluated by determining signs and symptoms, rhinoscopy, nasal function, laboratory analysis, and safety assessments.
Group name:Mometasone Furoate in Nasal Spray Type of group
Subjects will receive 200 mg BID Mometasone Furoate in Nasal Spray for 4 months and will be evaluated by determining signs and symptoms, rhinoscopy, nasal function, laboratory analysis, and safety assessments.
Sponsors
SCHERING PLOUGH RESEARCH INSTITUTE,
Eligibility
Inclusion criteria
Inclusion criteria: 1. The subjects must present a diagnosis of bilateral nasal polyps both at the Selection Visit and at the Start Visit. 2. The subjects should present clinically significant nasal congestion / obstruction, with an instant morning score> 2 in each of the last seven days of the initial two-week period. 3. The subjects must have a good state of health and not suffer from any clinically significant disease that could interfere with the chronogram or study procedures, or that could compromise the subject´s safety.
Exclusion criteria
Exclusion criteria: • Patients with a history of allergic rhinitis park / in the last two years. • Patients who have undergone nasal or sinus surgery in the last 6 months. • Patients with presumed fibrotic nasal polyposis. 6. Subjects to whom three or more nasal surgeries have been performed. • Patients with complete (or almost complete) nasal obstruction. • Patients presenting acute sinusitis or concurrent nasal infection, or who have had a nasal infection in the two weeks prior to the Screening Visit. • Patients hypersensitive to corticosteroids, or allergic to aspirin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:They will be evaluated by determining signs and symptoms, rhinoscopies, nasal function, laboratory analysis, and safety assessments. Measure:Efficacy and safety of two doses of MFNS in the treatment of nasal polyps. Timepoints:Day 8, Month 1. Month 2, Month 3 and Month 4. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Not contemplated Measure:Not contemplated Timepoints:Not contemplated | — |
Countries
Peru
Contacts
Public ContactJorge Timoteo
SCHERING PLOUGH DEL PERU S.A.
Outcome results
None listed