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
Overview[ - collapse ][ - ]
| Purpose | 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. |
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| Condition | Sinusitis Nasal Polyps Asthma |
| Intervention | Drug: Montelukast Drug: mometasone furoate nasal spray |
| Phase | Phase 4 |
| Sponsor | First Affiliated Hospital, Sun Yat-Sen University |
| Responsible Party | First Affiliated Hospital, Sun Yat-Sen University |
| ClinicalTrials.gov Identifier | NCT02110654 |
| First Received | March 31, 2014 |
| Last Updated | April 8, 2014 |
| Last verified | March 2014 |
Tracking Information[ + expand ][ + ]
| First Received Date | March 31, 2014 |
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| Last Updated Date | April 8, 2014 |
| Start Date | June 2014 |
| Estimated Primary Completion Date | June 2016 |
| Current Primary Outcome Measures | Percentage of Participants with Decrease in Nasal symptome Visual Analogue Scale (VAS) [Time Frame: 9 months] [Designated as safety issue: No]nasal symptoms include general symptom, congestion, rhinorrhea, olfactory loss and headache. |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief 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 |
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| 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 |
| 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 Type | Interventional |
| Study Phase | Phase 4 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment |
| Condition |
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| Intervention | Drug: Montelukast Other Names: singulairDrug: mometasone furoate nasal spray Other Names: nasonex |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Not yet recruiting |
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| Estimated Enrollment | 60 |
| Estimated Completion Date | June 2016 |
| Estimated Primary Completion Date | March 2016 |
| 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. |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Jianbo Shi, doctor 8602087333733 shijb@mail.sysu.edu.cn |
| Location Countries | China |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT02110654 |
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| Other Study ID Numbers | 20140329 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | First Affiliated Hospital, Sun Yat-Sen University |
| Study Sponsor | First Affiliated Hospital, Sun Yat-Sen University |
| Collaborators | Not Provided |
| Investigators | Study Director: jianbo shi, doctor Ent department, the first affiliated hospital, Sun Yat-sen University |
| Verification Date | March 2014 |
Locations[ + expand ][ + ]
| the first affiliated hospital, Sun Yat-sen University | Guangzhou, Guangdong, China, 510080 Contact: Fenghong Chen, doctor | 02086013560170816 | chfhong@mail.sysu.edu.cnPrincipal Investigator: jianbo Shi, doctor Not yet recruiting |
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