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

Phase 4

Completed

• Conditions: Nasal Polyps; Asthma; Sinusitis
• Interventions: Drug: Montelukast; Drug: mometasone furoate nasal spray

• Registration Number: NCT02110654
• Lead Sponsor: First Affiliated Hospital, Sun Yat-Sen University

Brief 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

Study Timeline

• Study First Submitted: 2014-03-31
• Study First Submitted QC: 2014-04-08
• Study First Posted: 2014-04-10
• Study Start: 2014-06
• Status Verified: 2020-11
• Primary Completion: 2020-11-01
• Study Completion: 2020-11-01
• Last Update Submitted: 2020-11-19
• Last Update Posted: 2020-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Diagnosis of chronic rhinosinusitis according to European position paper of rhinosinusitis and nasal polyps 2007
2. Diagnosis of asthma based on Global initiative for asthma 2012
3. All patients should provide informed consent prior to the study and agree to follow-up appointments.

Exclusion Criteria

1. Immunodeficiency diseases, history of head and/or facial trauma, cancer or organ transplant recipients.
2. Pregnancy or lactation.
3. Uncontrolled bronchial asthma.
4. Acute respiratory tract infection within one month before the study.
5. Use of leukotriene receptor antagonist within 3 months before the enrollment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mometasone furoate nasal spray	Montelukast	mometasone furoate nasal spray,200ug qd, 6 months
mometasone furoate nasal spray combined with montelukast	Montelukast	montelukast tablet,10mg,qd + mometasone furoate nasal spray, 200ug qd,6 months
mometasone furoate nasal spray combined with montelukast	mometasone furoate nasal spray	montelukast tablet,10mg,qd + mometasone furoate nasal spray, 200ug qd,6 months

Primary Outcome Measures

Name	Time	Method
Percentage of Participants with Decrease in Nasal symptome Visual Analogue Scale (VAS)	9 months	nasal symptoms include general symptom, congestion, rhinorrhea, olfactory loss and headache.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants with Decrease in nasal endoscopy score (Lund-Kennedy score)	9 months	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
Percentage of Participants with Decrease in sinus CT score (Lund-Mackay, scoring system)	6 months	baseline, 6 months post-FESS
Percentage of Participants with Increase in Asthma Control test (ACT)	9 months	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
Number of Participants with Serious and Non-Serious Adverse Events	9 months	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

Trial Locations

Locations (1)

the first affiliated hospital, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China