Clinical trial NCT02110654: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sinusitis
Nasal Polyps
Asthma
Keywords: chronic rhinosinusitis
asthma
montelukast
surgery
treatment outcomes
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2014-04-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There are two study groups listed as below.

1. Montelukast 10mg once daily + Mometasone furoate nasal spray 100 µg/per nostril once daily for 6 months.
2. Mometasone furoate nasal spray 100 µg/per nostril once daily for 6 months.
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants with Decrease in Nasal symptome Visual Analogue Scale (VAS)
timeFrame: 9 months
Secondary outcomes:
measure: Percentage of Participants with Decrease in nasal endoscopy score (Lund-Kennedy score)
timeFrame: 9 months
measure: Percentage of Participants with Decrease in sinus CT score (Lund-Mackay, scoring system)
timeFrame: 6 months
measure: Percentage of Participants with Increase in Asthma Control test (ACT)
timeFrame: 9 months
measure: Number of Participants with Serious and Non-Serious Adverse Events
timeFrame: 9 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: the first affiliated hospital, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Ent department, the first affiliated hospital, Sun Yat-sen University
name: jianbo shi, doctor
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.