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
|ClinicalTrials.gov Identifier: NCT02110654|
Recruitment Status : Unknown
Verified March 2014 by Jianbo Shi, First Affiliated Hospital, Sun Yat-Sen University.
Recruitment status was: Not yet recruiting
First Posted : April 10, 2014
Last Update Posted : April 10, 2014
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Sinusitis Nasal Polyps Asthma||Drug: Montelukast Drug: mometasone furoate nasal spray||Phase 4|
- 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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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 Start Date :||June 2014|
|Estimated Primary Completion Date :||March 2016|
|Estimated Study Completion Date :||June 2016|
Active Comparator: mometasone furoate nasal spray
mometasone furoate nasal spray,200ug qd, 6 months
Other Name: singulair
Experimental: mometasone furoate nasal spray combined with montelukast
montelukast tablet,10mg,qd + mometasone furoate nasal spray, 200ug qd,6 months
Other Name: singulair
Drug: mometasone furoate nasal spray
Other Name: nasonex
- Percentage of Participants with Decrease in Nasal symptome Visual Analogue Scale (VAS) [ Time Frame: 9 months ]nasal symptoms include general symptom, congestion, rhinorrhea, olfactory loss and headache.
- Percentage of Participants with Decrease in nasal endoscopy score (Lund-Kennedy score) [ Time Frame: 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) [ Time Frame: 6 months ]baseline, 6 months post-FESS
- Percentage of Participants with Increase in Asthma Control test (ACT) [ Time Frame: 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 [ Time Frame: 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02110654
|Contact: Jianbo Shi, email@example.com|
|the first affiliated hospital, Sun Yat-sen University||Not yet recruiting|
|Guangzhou, Guangdong, China, 510080|
|Contact: Fenghong Chen, doctor 02086013560170816 firstname.lastname@example.org|
|Principal Investigator: jianbo Shi, doctor|
|Study Director:||jianbo shi, doctor||Ent department, the first affiliated hospital, Sun Yat-sen University|