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 | Completed Phase 4 DMC

• 1 other identifier: 20140329
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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. 3.study design This study is a 9-month randomized, open-label, controlled interventional study.

Conditions

Sinusitis; Nasal Polyps; Asthma

Keywords

chronic rhinosinusitis; asthma; montelukast; surgery; treatment outcomes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Percentage of Participants with Decrease in nasal endoscopy score (Lund-Kennedy score)

  9 months

• Percentage of Participants with Decrease in sinus CT score (Lund-Mackay, scoring system)

  6 months

• Percentage of Participants with Increase in Asthma Control test (ACT)

  9 months

• Number of Participants with Serious and Non-Serious Adverse Events

  9 months

Study Arms (2)

mometasone furoate nasal spray

ACTIVE COMPARATOR

mometasone furoate nasal spray,200ug qd, 6 months

Drug: Montelukast

mometasone furoate nasal spray combined with montelukast

EXPERIMENTAL

montelukast tablet,10mg,qd + mometasone furoate nasal spray, 200ug qd,6 months

Drug: Montelukast; Drug: mometasone furoate nasal spray

Interventions

Montelukast DRUG

Also known as: singulair

mometasone furoate nasal spray; mometasone furoate nasal spray combined with montelukast

mometasone furoate nasal spray DRUG

Also known as: nasonex

mometasone furoate nasal spray combined with montelukast

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

the first affiliated hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

Related Publications (2)

• Hong H, Chen F, Sun Y, Yang Q, Gao W, Cao Y, Fan Y, Shi J, Li H. Nasal IL-25 predicts the response to oral corticosteroids in chronic rhinosinusitis with nasal polyps. J Allergy Clin Immunol. 2018 May;141(5):1890-1892. doi: 10.1016/j.jaci.2017.10.050. Epub 2018 Jan 11. No abstract available.

  PMID: 29337030 DERIVED

• Chen F, Hong H, Sun Y, Hu X, Zhang J, Xu G, Zhao W, Li H, Shi J. Nasal interleukin 25 as a novel biomarker for patients with chronic rhinosinusitis with nasal polyps and airway hypersensitiveness: A pilot study. Ann Allergy Asthma Immunol. 2017 Oct;119(4):310-316.e2. doi: 10.1016/j.anai.2017.07.012. Epub 2017 Sep 1.

  PMID: 28870448 DERIVED

MeSH Terms

Conditions

Sinusitis; Nasal Polyps; Asthma

Interventions

montelukast; Mometasone Furoate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• jianbo shi, doctor

  Ent department, the first affiliated hospital, Sun Yat-sen University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy director of ENT department

Model Details: There are two study groups listed as below. 1. Montelukast 10mg once daily + Mometasone furoate nasal spray 100 µg/per nostril once daily for 6 months. 2. Mometasone furoate nasal spray 100 µg/per nostril once daily for 6 months.

Study Record Dates

• First Submitted: March 31, 2014
• First Posted: April 10, 2014
• Study Start: June 1, 2014
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2020
• Last Updated: November 23, 2020

Record last verified: 2020-11

Locations

CN (1)