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Characterisation and intervention study in patients with long-term use of nasal decongestants.
EU CTIS ID: 2024-516312-25-00
What this study is testing
Primary objective: To evaluate the effectiveness (success rate) of a standardized, structured withdrawal plan based on Mometasone combined with motivational interviewing to reduce overuse of nasal decongestants. Co-primary objective: To evaluate the relapse rates of patients with former nasal decongestant overuse.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Part A-healthy volunteers: Aged 18 years or older
- Part A-healthy volunteers: Sufficient knowledge of the Dutch language
- Part A and B- participants with overuse of nasal decongestants: Aged 18 years or older
- Part A and B- participants with overuse of nasal decongestants: Daily use of nasal decongestant for at least 6 months
- Part A and B- participants with overuse of nasal decongestants: Sufficient knowledge of the Dutch language
You likely can't join if
- Part A-healthy volunteers: Subjective presence of nasal disease (i.e. the study subject indicates to experience any nasal symptoms, an occasional common cold not taken into account)
- Part A-healthy volunteers: Pregnancy, trying to become pregnant (during the duration of the study) or breastfeeding
- Part A - participants with overuse of nasal decongestants: Pregnancy, trying to become pregnant (during the duration of the study) or breastfeeding
- Part A - participants with overuse of nasal decongestants: Use of an oral corticosteroid in the month prior to the screening visit (T-2)
- Part A - participants with overuse of nasal decongestants: Use of an oral decongestant in the week prior to the screening visit (T-2)
- Part A - participants with overuse of nasal decongestants: Significant disease(s) that might interfere with the study, based on the judgement of the investigator
See the full eligibility criteria
- Part A-healthy volunteers: Aged 18 years or older
- Part A-healthy volunteers: Sufficient knowledge of the Dutch language
- Part A and B- participants with overuse of nasal decongestants: Aged 18 years or older
- Part A and B- participants with overuse of nasal decongestants: Daily use of nasal decongestant for at least 6 months
- Part A and B- participants with overuse of nasal decongestants: Sufficient knowledge of the Dutch language
- Part A-healthy volunteers: Subjective presence of nasal disease (i.e. the study subject indicates to experience any nasal symptoms, an occasional common cold not taken into account)
- Part A-healthy volunteers: Pregnancy, trying to become pregnant (during the duration of the study) or breastfeeding
- Part A - participants with overuse of nasal decongestants: Pregnancy, trying to become pregnant (during the duration of the study) or breastfeeding
- Part A - participants with overuse of nasal decongestants: Use of an oral corticosteroid in the month prior to the screening visit (T-2)
- Part A - participants with overuse of nasal decongestants: Use of an oral decongestant in the week prior to the screening visit (T-2)
- Part A - participants with overuse of nasal decongestants: Significant disease(s) that might interfere with the study, based on the judgement of the investigator
- Part B- participants with overuse of nasal decongestants: Pregnancy, trying to become pregnant (during the duration of the study) or breastfeeding
- Part B- participants with overuse of nasal decongestants: Glaucoma
- Part B- participants with overuse of nasal decongestants: Use of an oral corticosteroid in the month prior to the start of the intervention (T1)
- Part B- participants with overuse of nasal decongestants: Use of an oral decongestant in the week prior to the start of the intervention (T1)
- Part B- participants with overuse of nasal decongestants: Significant disease(s) that might interfere with the study, based on the judgement of the investigator
- Part A-healthy volunteers: Established diagnosis of a nasal disorder (e.g. allergy, nasal polyps, …) or a positive allergy test (skin prick test or blood test)
- Part A-healthy volunteers: Prior nasal surgery
- Part A-healthy volunteers: Asthma
- Part A-healthy volunteers: Use of an oral corticosteroid in the month prior to the screening visit (T-2)
- Part A-healthy volunteers: Significant disease(s) that might interfere with the study, based on the judgement of the investigator.
- Part A-healthy volunteers: Current use of a nasal decongestant, more than two episodes of 7 days use of a nasal decongestant in the previous year or less than two episodes of 7 days use (in the previous year) but last use less than a month prior to the screening visit (T-2)
- Part A-healthy volunteers: Other medication used to treat nasal symptoms (intranasal corticosteroids, oral or intranasal antihistamines, oral decongestants…)
- Part A-healthy volunteers: History of rhinitis medicamentosa (either patient-reported long-term use of a nasal decongestant or a diagnosis of rhinitis medicamentosa)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.