Mometasone Furoate Nasal Spray for Treatment of Nasal Polyposis After Surgery (Study P03218)
Primary Purpose
Nasal Polyps
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Mometasone Furoate Nasal Spray
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Nasal Polyps focused on measuring functional, endoscopic, sinus, surgery
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Mometasone Furoate Nasal Spray (MFNS)
Placebo
Arm Description
MFNS 200 mcg (2 sprays of 50 mcg in each nostril) once daily in the morning
Placebo nasal spray (2 sprays of 50 mcg in each nostril) once daily in the morning
Outcomes
Primary Outcome Measures
Time to relapse in polyp score after surgery
Secondary Outcome Measures
Signs and symptom scores
Quality of life, peak nasal inspiratory flow, olfaction threshold
Adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00731185
Brief Title
Mometasone Furoate Nasal Spray for Treatment of Nasal Polyposis After Surgery (Study P03218)
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2003 (Actual)
Primary Completion Date
September 1, 2005 (Actual)
Study Completion Date
September 1, 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organon and Co
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasal Polyps
Keywords
functional, endoscopic, sinus, surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
162 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mometasone Furoate Nasal Spray (MFNS)
Arm Type
Experimental
Arm Description
MFNS 200 mcg (2 sprays of 50 mcg in each nostril) once daily in the morning
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo nasal spray (2 sprays of 50 mcg in each nostril) once daily in the morning
Intervention Type
Drug
Intervention Name(s)
Mometasone Furoate Nasal Spray
Other Intervention Name(s)
Nasonex, SCH 032088
Intervention Description
MFNS 200 mcg (2 sprays of 50 mcg in each nostril) once daily in the morning for up to 24 weeks or until relapse
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo (2 sprays of 50 mcg in each nostril) once daily in the morning for up to 24 weeks or until relapse
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Signs and symptom scores
Time Frame
All study visits (up to 24 weeks of treatment)
Title
Quality of life, peak nasal inspiratory flow, olfaction threshold
Time Frame
Measured starting 1 week after treatment up to 24 weeks of treatment
Title
Adverse events
Time Frame
Throughout the whole study after the Screening period.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Citations:
PubMed Identifier
19289710
Citation
Stjarne P, Olsson P, Alenius M. Use of mometasone furoate to prevent polyp relapse after endoscopic sinus surgery. Arch Otolaryngol Head Neck Surg. 2009 Mar;135(3):296-302. doi: 10.1001/archoto.2009.2.
Results Reference
derived
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis
Available IPD/Information URL
http://www.merck.com/clinical-trials/policies-perspectives.html
Learn more about this trial
Mometasone Furoate Nasal Spray for Treatment of Nasal Polyposis After Surgery (Study P03218)
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