Research on Underlying Causes of Long-term Use of Nasal Decongestants and the Structured Withdrawal of the Decongestant
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- STATUS
- Recruiting
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- days left to enroll
- 35
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- participants needed
- 125
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- sponsor
- University Hospital, Ghent
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 which leads to rebound congestion when the medication wears off. This prompts the user of the nasal decongestant to administer more in order to obtain relief from the feeling of a blocked nose. Therefore, the patient ends up in a vicious cycle caused and temporarily relieved by the use of medication.The diagnosis of rhinitis medicamentosa depends greatly on the history of prolonged use of the nasal decongestant, since real diagnostic criteria have not yet been established. It is unclear if these patients suffer from an underlying (undetected and/or untreated) nasal condition which might have caused the patient to start using the nasal decongestant in the first place. Therefore, the aim of the first part of this study (Part A) is to characterize patients with long-term use of nasal decongestants to examine if an underlying nasal condition is present. The investigators will include healthy volunteers in part A of the study to be able to compare their test results with those of patients with long-term use of nasal decongestants and hence be able to detect differences.
Thus far, the treatment of RM has been the topic of debate. Several treatment regimens have been proposed in literature, but most study authors agree that it is essential to stop the overuse of the nasal decongestant either immediately or gradually to limit withdrawal symptoms. For this part of the study (Part B: intervention study), the investigators aim to reduce the long-term use of nasal decongestants based on a structured withdrawal programme comprising medication (nasal corticosteroid spray) and motivational interviewing. Only patients with long-term use of nasal decongestants are eligible to participate in this part of the study. They will be rescreened prior to inclusion into this part of the study.
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-term use of nasal decongestants). Patients will be rescreened prior to inclusion into part B of the study. Participants will receive the intervention (Mometasone furoate nasal spray) during a 12-week period
Part A (characterisation study) consists of three study-related contact moments:
- Screening visit
- Telephone contact
- Ear-, nose- and throat examination (actual characterisation study)
Part B (intervention study) consists of five contact moments:
- Start-up of the intervention
- Telephone contact (during follow-up 1 period)
- Follow-up 1 (After 6 weeks of intervention*)
- Follow-up 2 (After 12 weeks of intervention*)
- Telephone follow-up (6 months post start-up of the intervention*) * Study windows foreseen in the protocol
Procedures performed during part A of the study:
- Peak Nasal Inspiratory Flow (PNIF) measurements
- Nasal endoscopy
- Collection of blood samples and nasal secretions
- Completion of questionnaires
- Completion of patient diary
- Collection of data regarding medication use
- Skin prick testing
- Completion of patient diary
- Medical photography of the face and nose
- Telephone follow-up
Procedures performed during part B of the study:
- Urine pregnancy test
- Collection of data regarding medication use
- Counselling conversations with the researchers
- Completion of questionnaires
- Completion of patient diary
- Drug accountability
- Daily administration of Mometasone furoate (by the patients themselves, during a 12 week period)
- PNIF measurements
- Nasal endoscopy
- Collection of blood samples and nasal secretions
- Telephone follow-up
Details
| Condition | Rhinitis Medicamentosa |
|---|---|
| Treatment | Mometasone furoate |
| Clinical Study Identifier | NCT04898764 |
| Sponsor | University Hospital, Ghent |
| Last Modified on | 2 December 2021 |
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