Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study of Mometasone Nasal Spray Treatment for Patients with Rhinitis Medicamentosa (Nasal Decongestant Dependency)

Fast replyRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on rhinitis medicamentosa, a condition where the nose becomes congested due to overuse of nasal decongestant sprays. The research aims to evaluate the effectiveness of a treatment plan that helps patients stop using nasal decongestants through a combination of mometasone furoate nasal spray and supportive counseling.

The treatment involves using mometasone furoate, a type of steroid nasal spray, as part of a structured plan to help patients reduce and eventually stop their dependence on decongestant nasal sprays. The study will monitor patients for 12 weeks during the treatment phase and continue following up with them to check if they maintain their progress.

Throughout the study, patients will be asked to keep track of their nasal symptoms and breathing ability. The study will measure how well patients can breathe through their nose, assess their quality of sleep, and examine the inside of their nose to monitor any changes. The research team will also evaluate how many patients successfully stop using decongestant sprays and whether they maintain this improvement over time.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Your participation begins with an evaluation of your current nasal decongestant use, which must have been daily for at least 6 months

    Medical staff will perform a nasal endoscopy examination to assess your nasal passages

    You will complete several questionnaires about your nasal symptoms and sleep quality

  2. Step 2

    Starting intervention

    You will begin using Mometasone nasal spray according to a structured withdrawal plan

    You will need to maintain a daily diary to track your symptoms

    Weekly measurements of your Peak Nasal Inspiratory Flow (PNIF) will be recorded at home

  3. Step 3

    12-week intervention period

    Regular assessment of your nasal symptoms using the Rhinitis Control Assessment Test (RCAT)

    Tracking of your nasal breathing capacity through hospital PNIF measurements

    Evaluation of your quality of life using specific questionnaires

    Assessment of your nasal symptoms using a visual scale

  4. Step 4

    Success evaluation

    The goal is to achieve complete withdrawal from nasal decongestants, defined as 7 consecutive days without use

    Your nasal symptoms and overall progress will be evaluated

  5. Step 5

    6-month follow-up

    Final assessment to check if you have maintained withdrawal from nasal decongestants

    Evaluation for any relapse, defined as returning to daily nasal decongestant use for more than 7 consecutive days

    Final measurements of nasal function and symptom assessment

Who can join the trial?

6 criteria

  • Must be 18 years of age or older
  • Must be able to understand and communicate in Dutch language fluently
  • For participants with nasal decongestant overuse:
    • Must have been using nasal decongestant sprays or drops daily for at least 6 months (these are medications that help clear stuffy nose)
    • Both men and women can participate in the study
    • Must be willing to participate in either:
      • Part A as a healthy volunteer
      • Part A or B as someone who overuses nasal decongestants

Who cannot join the trial?

13 criteria

  • Age under 18 years or over 65 years
  • Current pregnancy or breastfeeding
  • Presence of anatomical nasal defects (structural problems in the nose)
  • History of nasal surgery within the past 6 months
  • Current diagnosis of severe allergic rhinitis (serious allergic nose inflammation)
  • Active nasal infection or sinusitis (infection of the sinuses)
  • Use of systemic corticosteroids (anti-inflammatory medications taken as pills or injections) within the past month
  • Diagnosis of other serious medical conditions that could affect nasal symptoms
  • Current participation in other clinical trials
  • Known allergy or sensitivity to mometasone (the study medication)
  • Inability to follow study procedures or attend scheduled visits
  • History of chronic rhinosinusitis (long-term inflammation of nose and sinuses)
  • Severe psychiatric disorders that could interfere with study participation
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Mometasone

    is a corticosteroid nasal spray that helps reduce inflammation in the nasal passages. It works by decreasing swelling and irritation in the nose, making it easier to breathe. In this trial, it is used as part of a withdrawal plan to help patients who have become dependent on nasal decongestants.

  • Nasal decongestants

    are medications that provide temporary relief from nasal congestion by shrinking swollen blood vessels in the nasal passages. While effective for short-term use, these medications can lead to dependence when used for extended periods, which is why this study focuses on helping patients reduce their overuse of these products.

What is already known about the treatment

Mometasone – A prescription nasal corticosteroid spray that works by reducing inflammation in the nasal passages to help relieve allergy and congestion symptoms. It belongs to the class of corticosteroid medications and acts by suppressing the activity of various inflammatory cells and reducing the production of inflammatory substances in the nasal tissue. The medication is particularly effective in treating rhinitis medicamentosa (rebound congestion from overuse of decongestant nasal sprays) and is used as part of a structured withdrawal plan to help patients stop using over-the-counter decongestant sprays. When used as directed, it typically begins working within 12 hours and reaches its full effect after a few days of regular use. Note: Since no other specific medications are mentioned in the trial data, I've only provided a description for Mometasone, which is explicitly mentioned in the trial objective.

Investigated diseases

Rhinitis Medicamentosa - A condition that occurs due to prolonged use of nasal decongestant sprays, typically lasting more than 5-7 days. It is characterized by a rebound nasal congestion that develops as a result of overusing topical decongestants. The condition creates a cycle where the person experiences increasingly severe nasal congestion when the decongestant wears off, leading to more frequent use of the spray. Over time, the nasal tissues become less responsive to the decongestant, requiring more frequent applications to achieve the same effect. The nasal mucosa may become swollen, red, and chronically congested.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516312-25-00Protocol codeAGO/2019/005Estimated enrolment135 patientsSponsorUniversitair Ziekenhuis Gent

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).