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

Nasal Polyps Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00731185
• Other study ID #: P03218
• Status: Completed
• Phase: Phase 3
• Start date: September 1, 2003
• Est. completion date: September 1, 2005

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: September 1, 2005
• Est. primary completion date: September 1, 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nasal Polyps

Intervention

Drug:
• Mometasone Furoate Nasal Spray
MFNS 200 mcg (2 sprays of 50 mcg in each nostril) once daily in the morning for up to 24 weeks or until relapse
• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to relapse in polyp score after surgery		Assessment for relapse was performed at every study visit (up to 24 weeks of treatment)
Secondary	Signs and symptom scores		All study visits (up to 24 weeks of treatment)
Secondary	Quality of life, peak nasal inspiratory flow, olfaction threshold		Measured starting 1 week after treatment up to 24 weeks of treatment
Secondary	Adverse events		Throughout the whole study after the Screening period.