AzTrials
AzTrials

SinusitisPhase 4NCT02110654

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 Phase 4 study testing Montelukast and mometasone furoate nasal spray in people with Sinusitis and Nasal Polyps, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Sinusitis, Nasal Polyps, Asthma
What is being tested?
Montelukast and mometasone furoate nasal spray
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteChina
Study dates
Jun 2014to 1 Nov 2020
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • the first affiliated hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510080

Other trials in China

About this study

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

  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.
Read the 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.
  1. 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
  1. 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
Being tested
Montelukast, mometasone furoate nasal spray
Keywords
chronic rhinosinusitis, asthma, montelukast, surgery, treatment outcomes
Medical subject headings
Sinusitis, Nasal Polyps, Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MontelukastDrug

    Also called singulair

  • mometasone furoate nasal sprayDrug

    Also called nasonex

Study groups in NCT02110654
Study groupRoleWhat they receive
mometasone furoate nasal sprayActive comparatormometasone furoate nasal spray,200ug qd, 6 months
Receives: Drug: Montelukast
mometasone furoate nasal spray combined with montelukastExperimentalmontelukast tablet,10mg,qd + mometasone furoate nasal spray, 200ug qd,6 months
Receives: Drug: Montelukast; Drug: mometasone furoate nasal spray

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants with Decrease in Nasal symptome Visual Analogue Scale (VAS)

    nasal symptoms include general symptom, congestion, rhinorrhea, olfactory loss and headache.

    Measured: 9 months

Secondary outcomes (4)

  1. 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

    Measured: 9 months

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

    baseline, 6 months post-FESS

    Measured: 6 months

  3. 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

    Measured: 9 months

  4. 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

    Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2014 (estimated)
  2. Study startJun 2014
  3. Primary completion1 Nov 2020
  4. Study completion1 Nov 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02110654
Sponsor's protocol ID
20140329
Status last verified
Nov 2020
First submitted
31 Mar 2014
Last updated
23 Nov 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 29337030

  • 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.

    PubMed 28870448

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Montelukast and mometasone furoate nasal spray in people with Sinusitis and Nasal Polyps, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants with Decrease in Nasal symptome Visual Analogue Scale (VAS) (time frame: 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02110654, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in