Comparison of Daily Mometasone Furoate Nasal Spray Alone Versus a Combination With Montelukast for Treatment of Chronic Rhinosinusitis With Asthma After Functional Endoscopic Sinus Surgery
Condition: Sinusitis; Nasal Polyps; Asthma
MeSH terms: Sinusitis; Asthma; Nasal Polyps
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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
    

Intervention name(s): Montelukast; mometasone furoate nasal spray
Intervention type(s): Drug; Drug
Other intervention name(s): singulair; nasonex
Intervention MeSH terms: Mometasone Furoate; Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: There are two study groups listed as below.
Montelukast 10mg once daily + Mometasone furoate nasal spray 100 µg/per nostril once daily for 6 months.
Mometasone furoate nasal spray 100 µg/per nostril once daily for 6 months.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: chronic rhinosinusitis; asthma; montelukast; surgery; treatment outcomes