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
NCT02110654 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2020-11-23
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.
Conditions
- Sinusitis
- Nasal Polyps
- Asthma
Interventions
- DRUG
-
Montelukast
- DRUG
-
mometasone furoate nasal spray
Sponsors & Collaborators
-
First Affiliated Hospital, Sun Yat-Sen University
lead OTHER
Principal Investigators
-
jianbo shi, doctor · Ent department, the first affiliated hospital, Sun Yat-sen University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-06-30
- Primary Completion
- 2020-11-01
- Completion
- 2020-11-01
Countries
- China
Study Locations
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