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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Universitair Ziekenhuis Gent	Gent	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	14.09.2020

Trial locations

Investigated drugs:

Mometasone Furoate

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.

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 ID:

2024-516312-25-00

Protocol code:

AGO/2019/005

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

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