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Surgery plan
Drug treatment phase Three days after the surgery (FESS) described above, all patients will be assigned to the following two groups (30 patients each group) using random numbers generated by statistical software.
Follow up After the 6-month drug treatment phase, there are still a 3-month follow-up. Totally, there are 5 visits after FESS surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mometasone furoate nasal spray | Active Comparator | mometasone furoate nasal spray,200ug qd, 6 months |
|
| mometasone furoate nasal spray combined with montelukast | Experimental | montelukast tablet,10mg,qd + mometasone furoate nasal spray, 200ug qd,6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Montelukast | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Decrease in Nasal symptome Visual Analogue Scale (VAS) | nasal symptoms include general symptom, congestion, rhinorrhea, olfactory loss and headache. | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Decrease in nasal endoscopy score (Lund-Kennedy score) | Visit 1: baseline Visit 2:Day 31 post-FESS Visit 3: Day 61 post-FESS Visit 4: Day 91 post-FESS Visit 5: Day 181 post-FESS Visit 6: Day 271 post-FESS | 9 months |
| Percentage of Participants with Decrease in sinus CT score (Lund-Mackay, scoring system) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| jianbo shi, doctor | Ent department, the first affiliated hospital, Sun Yat-sen University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the first affiliated hospital, Sun Yat-sen University | Guangzhou | Guangdong | 510080 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29337030 | Derived | Hong H, Chen F, Sun Y, Yang Q, Gao W, Cao Y, Fan Y, Shi J, Li H. Nasal IL-25 predicts the response to oral corticosteroids in chronic rhinosinusitis with nasal polyps. J Allergy Clin Immunol. 2018 May;141(5):1890-1892. doi: 10.1016/j.jaci.2017.10.050. Epub 2018 Jan 11. No abstract available. | |
| 28870448 | Derived |
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There are two study groups listed as below.
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| mometasone furoate nasal spray | Drug |
|
|
baseline, 6 months post-FESS |
| 6 months |
| Percentage of Participants with Increase in Asthma Control test (ACT) | Visit 1: baseline Visit 2:Day 31 post-FESS Visit 3: Day 61 post-FESS Visit 4: Day 91 post-FESS Visit 5: Day 181 post-FESS Visit 6: Day 271 post-FESS | 9 months |
| Number of Participants with Serious and Non-Serious Adverse Events | Visit 1: baseline Visit 2:Day 31 post-FESS Visit 3: Day 61 post-FESS Visit 4: Day 91 post-FESS Visit 5: Day 181 post-FESS Visit 6: Day 271 post-FESS | 9 months |
| Chen F, Hong H, Sun Y, Hu X, Zhang J, Xu G, Zhao W, Li H, Shi J. Nasal interleukin 25 as a novel biomarker for patients with chronic rhinosinusitis with nasal polyps and airway hypersensitiveness: A pilot study. Ann Allergy Asthma Immunol. 2017 Oct;119(4):310-316.e2. doi: 10.1016/j.anai.2017.07.012. Epub 2017 Sep 1. |
| ID | Term |
|---|---|
| D012852 | Sinusitis |
| D009298 | Nasal Polyps |
| D001249 | Asthma |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010254 | Paranasal Sinus Diseases |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001982 | Bronchial Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C093875 | montelukast |
| D000068656 | Mometasone Furoate |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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