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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02110654
• Other study ID #: 20140329
• Status: Completed
• Phase: Phase 4
• Start date: June 2014
• Est. completion date: November 1, 2020

Study information

• Verified date: November 2020
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 1, 2020
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Nasal Polyps
• Sinusitis

Intervention

Drug:
• Montelukast

• mometasone furoate nasal spray

Locations

Country	Name	City	State
China	the first affiliated hospital, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants with Decrease in Nasal symptome Visual Analogue Scale (VAS)	nasal symptoms include general symptom, congestion, rhinorrhea, olfactory loss and headache.	9 months
Secondary	Percentage of Participants with Decrease in nasal endoscopy score (Lund-Kennedy score)	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	9 months
Secondary	Percentage of Participants with Decrease in sinus CT score (Lund-Mackay, scoring system)	baseline, 6 months post-FESS	6 months
Secondary	Percentage of Participants with Increase in Asthma Control test (ACT)	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	9 months
Secondary	Number of Participants with Serious and Non-Serious Adverse Events	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	9 months