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Research on Underlying Causes of Long-term Use of Nasal Decongestants and the Structured Withdrawal of the Decongestant

NCT04898764 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2026-01-28

No results posted yet for this study

Summary

Rhinitis medicamentosa (RM) is a form of non-allergic medication-induced rhinitis characterised by nasal congestion. This nasal congestion is the result of the overuse of intranasal decongestants which leads to rebound congestion when the medication wears off. This prompts the user of the nasal decongestant to administer more in order to obtain relief from the feeling of a blocked nose. Therefore, the patient ends up in a vicious cycle caused and temporarily relieved by the use of medication.The diagnosis of rhinitis medicamentosa depends greatly on the history of prolonged use of the nasal decongestant, since real diagnostic criteria have not yet been established. It is unclear if these patients suffer from an underlying (undetected and/or untreated) nasal condition which might have caused the patient to start using the nasal decongestant in the first place. Therefore, the aim of the first part of this study (Part A) is to characterize patients with long-term use of nasal decongestants to examine if an underlying nasal condition is present. The investigators will include healthy volunteers in part A of the study to be able to compare their test results with those of patients with long-term use of nasal decongestants and hence be able to detect differences.

Thus far, the treatment of RM has been the topic of debate. Several treatment regimens have been proposed in literature, but most study authors agree that it is essential to stop the overuse of the nasal decongestant either immediately or gradually to limit withdrawal symptoms. For this part of the study (Part B: intervention study), the investigators aim to reduce the long-term use of nasal decongestants based on a structured withdrawal programme comprising medication (nasal corticosteroid spray) and motivational interviewing. Only patients with long-term use of nasal decongestants are eligible to participate in this part of the study. They will be rescreened prior to inclusion into this part of the study.

Conditions

  • Rhinitis Medicamentosa

Interventions

DRUG

Mometasone Furoate

Mometasone furoate nasal spray suspension, 50µg/actuation

Sponsors & Collaborators

  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Philippe Gevaert, MD, PhD · Ghent University Hospital, Ghent, Belgium

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-21
Primary Completion
2025-04-30
Completion
2025-04-30

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04898764 on ClinicalTrials.gov