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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

Sponsored by First Affiliated Hospital, Sun Yat-Sen University

About this trial

Last updated 5 years ago

Study ID

20140329

Status

Completed

Type

Interventional

Phase

Phase 4

Placebo

No

Accepting

18-75 Years
18 to 70 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 5 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

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.

No

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.