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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

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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
Sponsor:
Information provided by (Responsible Party):
Jianbo Shi, First Affiliated Hospital, Sun Yat-Sen University

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.

Condition or disease Intervention/treatment Phase
Sinusitis Nasal Polyps Asthma Drug: Montelukast Drug: mometasone furoate nasal spray Phase 4

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  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Endoscopy

Arm Intervention/treatment
Active Comparator: mometasone furoate nasal spray
mometasone furoate nasal spray,200ug qd, 6 months
Drug: Montelukast
Other Name: singulair

Experimental: mometasone furoate nasal spray combined with montelukast
montelukast tablet,10mg,qd + mometasone furoate nasal spray, 200ug qd,6 months
Drug: Montelukast
Other Name: singulair

Drug: mometasone furoate nasal spray
Other Name: nasonex




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. Percentage of Participants with Decrease in sinus CT score (Lund-Mackay, scoring system) [ Time Frame: 6 months ]
    baseline, 6 months post-FESS

  3. 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

  4. 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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02110654


Contacts
Contact: Jianbo Shi, doctor 8602087333733 shijb@mail.sysu.edu.cn

Locations
China, Guangdong
the first affiliated hospital, Sun Yat-sen University Not yet recruiting
Guangzhou, Guangdong, China, 510080
Contact: Fenghong Chen, doctor    02086013560170816    chfhong@mail.sysu.edu.cn   
Principal Investigator: jianbo Shi, doctor         
Sponsors and Collaborators
First Affiliated Hospital, Sun Yat-Sen University
Investigators
Study Director: jianbo shi, doctor Ent department, the first affiliated hospital, Sun Yat-sen University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jianbo Shi, Deputy director of ENT department, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT02110654     History of Changes
Other Study ID Numbers: 20140329
First Posted: April 10, 2014    Key Record Dates
Last Update Posted: April 10, 2014
Last Verified: March 2014

Keywords provided by Jianbo Shi, First Affiliated Hospital, Sun Yat-Sen University:
chronic rhinosinusitis
asthma
montelukast
surgery
treatment outcomes

Additional relevant MeSH terms:
Asthma
Sinusitis
Nasal Polyps
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Polyps
Pathological Conditions, Anatomical
Montelukast
Mometasone Furoate
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Dermatologic Agents