Status:
RECRUITING
Research on Underlying Causes of Long-term Use of Nasal Decongestants and the Structured Withdrawal of the Decongestant
Lead Sponsor:
University Hospital, Ghent
Conditions:
Rhinitis Medicamentosa
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 whic...
Detailed Description
The study comprises two parts: * Part A: Characterisation study (both healthy volunteers and patients with long-term use of nasal decongestants) * Part B: Intervention study (only patients with long-...
Eligibility Criteria
Inclusion
- Inclusion Criteria Healthy Volunteers (only included in part A of the study):
- Aged 18 years or older
- Sufficient knowledge of the Dutch language
- Exclusion Criteria Healthy Volunteers (only included in part A of the study):
- Subjective presence of nasal disease (i.e. the study subject indicates to experience any nasal symptoms, an occasional common cold not taken into account)
- Established diagnosis of a nasal disorder (e.g. allergy, nasal polyps, …) or a positive allergy test (skin prick test or blood test)
- Prior nasal surgery
- Asthma
- Use of an oral corticosteroid in the month prior to the screening visit
- Significant disease(s) that might interfere with the study, based on the judgement of the investigator
- 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
- Other medication used to treat nasal symptoms (intranasal corticosteroids, oral or intranasal antihistamines, oral decongestants …)
- History of rhinitis medicamentosa (either patient-reported long-term use of a nasal decongestant or a diagnosis of rhinitis medicamentosa)
- Pregnancy, trying to become pregnant (during the duration of the study) or breastfeeding
- Inclusion Criteria patients with long-term use of nasal decongestants: part A:
- Aged 18 years or older
- Daily use of a nasal decongestant for at least 6 months. Following ATC-codes are considered, when the spray or drops contain a nasal decongestant and the drug is thus intended for short-term use only: R01AA, R01AB, R01AD52, R01AD53
- Sufficient knowledge of the Dutch language
- Exclusion Criteria patients with long-term use of nasal decongestants: part A:
- Pregnancy, trying to become pregnant (during the duration of the study) or breastfeeding
- Use of an oral corticosteroid in the month prior to the screening visit
- Use of an oral decongestant in the week prior to the screening visit
- Significant disease(s) that might interfere with the study, based on the judgement of the investigator
- Inclusion Criteria patients with long-term use of nasal decongestants: part B:
- Aged 18 years or older
- Daily use of a nasal decongestant for at least 6 months.Following ATC-codes are considered, when the spray or drops contain a nasal decongestant and the drug is thus intended for short-term use only: R01AA, R01AB, R01AD52, R01AD53
- Sufficient knowledge of the Dutch language
- Exclusion Criteria patients with long-term use of nasal decongestants: part B:
- Pregnancy, trying to become pregnant (during the duration of the study) or breastfeeding
- Glaucoma
- Use of an oral corticosteroid in the month prior to the start of the intervention
- Use of an oral decongestant in the week prior to the start of the intervention
- Significant disease(s) that might interfere with the study, based on the judgement of the investigator
Exclusion
Key Trial Info
Start Date :
October 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT04898764
Start Date
October 21 2020
End Date
December 31 2025
Last Update
October 30 2024
Active Locations (1)
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1
Ghent University Hospital
Ghent, Belgium, 9000