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To investigate the usage of budesonide as an agent in the injection of Type 2 chronic rhinosinusitis with nasal polyps
this is a randomized controlled clinical trial where 3 groups with nasal polyps will be treated medically, Group A with oral corticosteroids, Group B with budesonide intrapolyp injection, Group C with placebo saline intrapolyp injection
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral steroid | Active Comparator | patients given prednisone 1 mg/kg for 3 days then tapered by 5mg daily for two weeks |
|
| Budesonide Intrapolyp injection | Experimental | patients given budesonide 0.5 mg/2ml intrapolyp injection once weekly for 5 consecutive weeks |
|
| Saline intrapolyp injection | Placebo Comparator | patients given 2ml normal saline intrapolyp injection once weekly for 5 consecutive weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Budesonide | Drug | after application of topical vasoconstrictor packs into both nasal cavities, using 1 cc 28 gauge needle sterile syringe, one pack of budesonide ampule 0.5 mg/2ml was injected into visible polyps on both cavities 1 ml in each cavity weekly for 5 consecutive weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Sino-Nasal Outcome Test "SNOT-22" Score | subjective method to assess the patient's quality of life "QOL" and the severity of the disease before and after treatment, The lower the score, The better the condition | 6 months |
| CT Lund Mackay | the radiological evaluation of patients with nasal polyps where each sinus was solitarily assigned a score from (0 to 2), where the Osteomeatal Complex was given only (0 or 2), each side was evaluated on its own and the sum of all sinuses was calculated. A combined score of 24 was the maximum. Investigators asked the patients for a CT scan before starting the treatment and 3 months after the completion of each treatment protocol | 6 months |
| Total nasal Polyp score "TNPS" | the clinical assessment of nasal polyps, the total nasal polyp score "TNPS" was used where polyp size was evaluated through endoscopy and given a score from (0 to 3). TNPS was calculated as the sum of the score on each side, and patients were assessed on regular visits before receiving treatment, 1 week after treatment, and after 3 months | 6 months |
| Serum IgE | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kafrelsheikh University hospital | Kafrelsheikh | Kafrelsheikh | 37458 | Egypt |
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| ID | Term |
|---|---|
| D019819 | Budesonide |
| D011241 | Prednisone |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Prednisone | Drug | patients given oral prednisone 1 mg/ kg with max. dose 70 mg/d divided into two doses for 3 days then tapered gradually for two weeks |
|
| Saline | Drug | saline intrapolyp injection |
|
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |