1. objectives. To compare the efficacy and the safety of mometasone furoate nasal spray (MFNS; Nasonex 200μg, daily) alone versus a combination with montelukast (singulair 10mg, daily) in chronic rhinosinusitis (CRS) with asthma after functional endoscopic sinus surgery (FESS) for improvement the clinical control of CRS 2. the clinical hypotheses. The investigators hypothesize that postoperative combined montelukast and MFNS can better improve clinical control of CRS concomitant with asthma after FESS compared with MFNS alone. 3. study design This study is a 9-month randomized, open-label, controlled interventional study.
1. Surgery plan * Pre-operation: Patients enrolled in the study will complete assessment and specimen collection on the first day, then followed by 1 week drug therapy with prednisone (30 mg once daily) and MFNS(200ug, once daily). * FESS: For patients with no surgical contraindications, FESS will be performed. Bilateral nasal cavities will be filled with swelling sponges postoperatively. The stuffing will be removed on postoperative day 2. The patients will be discharged on day 3 after surgery. * Other treatment: All patients will receive nasal irrigation (normal saline 500 mg twice daily) from postoperative day 3 until day 30. Asthma will be treated as the guidance of professors from the Department of Respiratory Medicine in the investigators hospital. 2. 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. * Experimental group: Montelukast (10mg, once daily) and MFNS (200μg, once daily) for 6 months * Control group: MFNS (200μg, once daily) for 6 months 3. 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. * 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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
50
the first affiliated hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Percentage of Participants with Decrease in Nasal symptome Visual Analogue Scale (VAS)
nasal symptoms include general symptom, congestion, rhinorrhea, olfactory loss and headache.
Time frame: 9 months
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
Time frame: 9 months
Percentage of Participants with Decrease in sinus CT score (Lund-Mackay, scoring system)
baseline, 6 months post-FESS
Time frame: 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
Time frame: 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
Time frame: 9 months
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