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

Study Overview
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Brief Summary
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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 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. study design This study is a 9-month randomized, open-label, controlled interventional study.

Detailed Description
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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. 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 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

Official Title
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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: a 9-month Randomized, Open-label, Controlled Study

Conditions
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Sinusitis, Nasal Polyps, Asthma

Intervention / Treatment
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* Drug: Montelukast
* Drug: mometasone furoate nasal spray


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of chronic rhinosinusitis according to European position paper of rhinosinusitis and nasal polyps 2007 Diagnosis of asthma based on Global initiative for asthma 2012 All patients should provide informed consent prior to the study and agree to follow-up appointments. Exclusion Criteria: Immunodeficiency diseases, history of head and/or facial trauma, cancer or organ transplant recipients. Pregnancy or lactation. Uncontrolled bronchial asthma. Acute respiratory tract infection within one month before the study. Use of leukotriene receptor antagonist within 3 months before the enrollment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: mometasone furoate nasal spray<br>mometasone furoate nasal spray,200ug qd, 6 months | Drug: Montelukast<br> <br> * Other names: singulair;|
| Experimental: mometasone furoate nasal spray combined with montelukast<br>montelukast tablet,10mg,qd + mometasone furoate nasal spray, 200ug qd,6 months | Drug: Montelukast<br> <br> * Other names: singulair;Drug: mometasone furoate nasal spray<br> <br> * Other names: nasonex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic rhinosinusitis, asthma, montelukast, surgery, treatment outcomes