Understanding and Managing Long-term Use of Nasal Decongestants
Characterisation and Intervention Study in Patients with Long-term Use of Nasal Decongestants
PHASE4 · University Hospital, Ghent · NCT04898764
This study is trying to help people who have become dependent on nasal decongestants by testing a new nasal spray treatment to see if it can improve their symptoms and help them stop using decongestants.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 135 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Ghent (other) |
| Locations | 1 site (Ghent) |
| Trial ID | NCT04898764 on ClinicalTrials.gov |
What this trial studies
This study investigates rhinitis medicamentosa, a condition caused by the overuse of nasal decongestants leading to rebound congestion. It consists of two parts: the first part characterizes patients with long-term decongestant use, while the second part involves an intervention using Mometasone furoate nasal spray over a 12-week period. Participants will undergo various assessments, including nasal examinations and questionnaires, to gather data on their condition and treatment response. The goal is to better understand the underlying causes of this condition and develop effective withdrawal strategies.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who have a history of long-term nasal decongestant use.
Not a fit: Patients with established nasal disorders or those currently using nasal decongestants may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide patients with effective strategies to manage and overcome dependency on nasal decongestants.
How similar studies have performed: While there is limited research specifically on rhinitis medicamentosa, similar approaches to managing medication dependency have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Ghent
- Ghent University Hospital — Ghent, Belgium (RECRUITING)
Study contacts
- Principal investigator: Philippe Gevaert, MD, PhD — Ghent University Hospital, Ghent, Belgium
- Study coordinator: Sophie Scheire, PhD, PharmD
- Email: sophie.scheire@ugent.be
- Phone: +32 9 332 64 22
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Rhinitis Medicamentosa, non-allergic drug-induced rhinitis