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Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Characterisation and intervention study in patients with long-term use of nasal decongestants.

This study aims to discover effective ways to help people who have been overusing nasal decongestant sprays. This overuse can make your nose feel even more blocked, a condition called rhinitis medicamentosa. The study is testing a different type of nasal spray called Mometasone. Researchers want to see if using Mometasone can help people completely stop using their old decongestant sprays. They are also looking at how many people stay off the decongestant sprays after stopping, and for how long. The study will check if peoples' symptoms improve, if their breathing through the nose gets better, and if their sleep and overall quality of life improve.

At a glance

Status
Ongoing, recruiting
Phase
Therapeutic use (Phase IV)
Sponsor
Universitair Ziekenhuis Gent
Enrolment target
135
Start
05 Sep 2024

What is this study about?

This study is for people who have been using nasal decongestant sprays much more than recommended for a long time. While these sprays can help in the short term, overusing them can actually make your nose feel even more blocked and stuffy – this is known as rhinitis medicamentosa. It can become a difficult cycle to break, as your nose relies on the spray to feel clear.

The main goal of this study is to see if a different type of nasal spray, called Mometasone, can help people break this cycle. Mometasone is a steroid nasal spray that works differently from decongestant sprays by reducing inflammation in the nose. Researchers want to find out how many people can successfully stop using their old decongestant sprays after starting Mometasone, and stay off them for a period of time. They are particularly interested in whether people can stop using decongestants for at least seven days in a row, and if they avoid going back to daily use later on.

The study will also look at several other factors. They will check if your overall nose symptoms improve, how easily you can breathe through your nose, and how your nasal passages look inside (using a small camera called an endoscope). They'll also ask about your sleep and how your nose problems affect your daily life and well-being. This information will help doctors understand if Mometasone is a good treatment option for breaking the cycle of decongestant overuse.

Key takeaways

  • This study aims to help people stop overusing nasal decongestant sprays.
  • It tests a different nasal spray called Mometasone.
  • The study wants to see how many people can successfully stop decongestant use and stay off it.
  • Participation involves using a nasal spray, keeping a diary, and clinic visits over 6 months.
  • It could improve your nasal health, breathing, and quality of life.

Who may be eligible?

To join this study, you need to be an adult, aged 18 years or older. Both men and women can take part. The most important thing is that you have been regularly using nasal decongestant sprays for a long time and are experiencing problems as a result. This means your nose feels persistently blocked or uncomfortable because of your decongestant use.

There might be other specific reasons why you can't join, which the study team will discuss with you. These could be related to other health conditions you might have or other medications you are taking. It's always important to share your full medical history with the study team.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Do you use nasal decongestant sprays regularly and for a long time?
  3. Do you feel your nose is blocked or uncomfortable because of this overuse?
  4. Are you able to attend clinic visits over a 6-month period?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the Mometasone nasal spray. The study team will guide you on how to use it. You'll be asked to keep a daily diary to record your symptoms and how much you use any nasal sprays. There will be several visits to the clinic over a period of 6 months. During these visits, the study team will check your symptoms, measure how well you can breathe through your nose, and may perform a nasal endoscopy (looking inside your nose with a small camera). They will also ask you to fill out questionnaires about your quality of life and sleep. The total duration of your participation in the study will be approximately 6 months.

Potential risks and benefits

Potential benefits could include learning how to manage your nasal symptoms without relying on decongestant sprays, improving your overall nasal health, and potentially better sleep and quality of life. As with any medication, Mometasone spray can have side effects, though these are usually mild and may include a dry or irritated nose, or occasional nosebleeds. The study team will explain all known side effects. You are free to withdraw from the study at any time and for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Unverified
    Belgium

Common questions

What is rhinitis medicamentosa?

It's when your nose gets more blocked and stuffy because you've been using decongestant nasal sprays too much or for too long.

What is Mometasone?

Mometasone is a type of steroid nasal spray that helps reduce swelling and inflammation in your nose, rather than just clearing it temporarily like decongestants.

Will I have to stop my current nasal spray immediately?

The study aims to help you stop your decongestant spray. The study team will guide you through this process, which might be gradual.

How long will the study last?

Your participation in the study will last for about six months.

What happens if I feel worse?

You should always tell the study team if you feel worse or have any concerns. You can leave the study at any time.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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