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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mometasone Furoate Nasal Spray (MFNS) | Experimental | MFNS 200 mcg (2 sprays of 50 mcg in each nostril) once daily in the morning |
|
| Placebo | Placebo Comparator | Placebo nasal spray (2 sprays of 50 mcg in each nostril) once daily in the morning |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mometasone Furoate Nasal Spray | Drug | MFNS 200 mcg (2 sprays of 50 mcg in each nostril) once daily in the morning for up to 24 weeks or until relapse |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to relapse in polyp score after surgery | Assessment for relapse was performed at every study visit (up to 24 weeks of treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Signs and symptom scores | All study visits (up to 24 weeks of treatment) | |
| Quality of life, peak nasal inspiratory flow, olfaction threshold | Measured starting 1 week after treatment up to 24 weeks of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19289710 | Derived | 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. |
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| ID | Term |
|---|---|
| D009298 | Nasal Polyps |
| D005402 | Fistula |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D011127 | Polyps |
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| ID | Term |
|---|---|
| D000068656 | Mometasone Furoate |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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|
| Placebo | Drug |
|
|
| Adverse events | Throughout the whole study after the Screening period. |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |