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
NCT ID: NCT02110654
Last Updated: 2020-11-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
50 participants
INTERVENTIONAL
2014-06-30
2020-11-01
Brief Summary
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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
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* 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
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
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.
TREATMENT
SINGLE
Study Groups
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mometasone furoate nasal spray
mometasone furoate nasal spray,200ug qd, 6 months
Montelukast
mometasone furoate nasal spray combined with montelukast
montelukast tablet,10mg,qd + mometasone furoate nasal spray, 200ug qd,6 months
Montelukast
mometasone furoate nasal spray
Interventions
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Montelukast
mometasone furoate nasal spray
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
70 Years
ALL
No
Sponsors
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First Affiliated Hospital, Sun Yat-Sen University
OTHER
Responsible Party
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Jianbo Shi
Deputy director of ENT department
Principal Investigators
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jianbo shi, doctor
Role: STUDY_DIRECTOR
Ent department, the first affiliated hospital, Sun Yat-sen University
Locations
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the first affiliated hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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References
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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.
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.
Other Identifiers
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20140329
Identifier Type: -
Identifier Source: org_study_id