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NCT Number: NCT02110654

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

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.

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Key information

Conditions

Sinusitis Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Infections Lung Diseases Lung Diseases, Obstructive Nasal Polyps Nose Diseases Otorhinolaryngologic Diseases Paranasal Sinus Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps Respiratory Hypersensitivity Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

the first affiliated hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

About this study

  • 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.
  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of chronic rhinosinusitis according to European position paper of rhinosinusitis and nasal polyps 2007
  • Diagnosis of asthma based on Global initiative for asthma 2012
  • All patients should provide informed consent prior to the study and agree to follow-up appointments.

Exclusion criteria

  • Immunodeficiency diseases, history of head and/or facial trauma, cancer or organ transplant recipients.
  • Pregnancy or lactation.
  • Uncontrolled bronchial asthma.
  • Acute respiratory tract infection within one month before the study.
  • Use of leukotriene receptor antagonist within 3 months before the enrollment.

Treatment and study plan

Montelukast

Drug

Other names: singulair

Mometasone Furoate Nasal spray

Drug

Other names: nasonex

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital, Sun Yat-Sen University

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Apr 10, 2014
Registry last updated
Nov 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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