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Topical and systemic steroids constitute the first choice in medical treatment for nasal polyps. This study aimed to evaluate the efficacy and safety of a short course of budesonide inhalation suspension via transnasal nebulization in the preoperative management of chronic rhinosinusitis with nasal polyposis. The second aim was to compare budesonide inhalation suspension with budesonide aqueous nasal spray and oral prednisone in nasal polyp treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| budesonide inhalation suspension | Experimental |
| |
| budesonide aqueous nasal spray | Active Comparator |
| |
| oral steroids | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| budesonide | Drug | 1mg/2ml Pulmicort Respules BIS twice daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical responses including 4 major symptoms(nasal obstruction, rhinorrhea, loss of smell,and headache/facial pain) | The primary efficacy outcome measure was the patients' assessment of four major symptoms improvement on an ordinal scaled visual analogue score of 0 to 10, where 0 indicates that no symptom is present and 10 signifies the presence of the most severe nasal obstruction, rhinorrhea, alteration in the sense of smell and headache/ facial pain. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Physicians' assessment of nasal polyp size reduction | the physicians' assessment of nasal polyp size reduction by endoscopic examination according to Kennedy score (0, no polyps; 1, polyps in the middle meatus, not reaching below the inferior border of the middle turbinate; 2, polyps reaching below the inferior border of the middle turbinate, but not below the inferior border of the inferior turbinate; 3, large polyps reaching below the inferior turbinate). Bilateral polyp grade was obtained as the sum of the individual grades for the left and right nasal cavities. A total score of 0-6 is possible. |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D019819 | Budesonide |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| budesonide |
| Drug |
nasal spray 256μg BID |
|
| Prednisone | Drug | oral prednisone 24mg QD |
|
| 2 weeks |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |