Research on Underlying Causes of Long-term Use of Nasal Decongestants and the Structured Withdrawal of the Decongestant

Phase 4

Recruiting

• Conditions: Rhinitis Medicamentosa
• Interventions: Drug: Mometasone Furoate

• Registration Number: NCT04898764
• Lead Sponsor: University Hospital, Ghent

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 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.

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-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:

1. Screening visit

2. Telephone contact

3. Ear-, nose- and throat examination (actual characterisation study)

Part B (intervention study) consists of five contact moments:

1. Start-up of the intervention

2. Telephone contact (during follow-up 1 period)

3. Follow-up 1 (After 6 weeks of intervention\*)

4. Follow-up 2 (After 12 weeks of intervention\*)

5. 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

Study Timeline

• Study First Submitted: 2020-10-16
• Study Start: 2020-10-21
• Study First Submitted QC: 2021-05-18
• Study First Posted: 2021-05-24
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-28
• Last Update Posted: 2024-10-30
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 135

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients with long-term use of nasal decongestants	Mometasone Furoate	A maximum of 100 patients with long-term use of nasal decongestants will be included in this study arm, for part A of the study (Characterisation study). The investigators will consecutively recruit patients from part A (Characterisation study) into part B of the study (Intervention study) until a total of 35 patients completed all study-related visits of part B. During the intervention study, patients with long-term use of nasal decongestants will administer Mometasone furoate intranasally, two doses (50µg/actuation) in each nostril, twice daily (total daily dose of 400µg) during a 12 week period.

Primary Outcome Measures

Name	Time	Method
Proportion of study subjects with long-term use of nasal decongestants able to completely withdraw the use of the nasal decongestant after 12 weeks of intervention.	Assessed at follow-up 2 (12 weeks post start up intervention)	To evaluate the effectiveness of a standardized, structured withdrawal plan based on Mometasone furoate combined with motivational interviewing to reduce the overuse of nasal decongestants.; For this study, complete withdrawal is defined as at least 7 consecutive days without any use of a nasal decongestant.
Proportion of study subjects who were able to completely withdraw the long-term use of nasal decongestants at follow-up 2 (after 12 weeks of intervention) who relapsed by the time of follow-up 3 (6 months after the start-up of the intervention).	Assessed at follow-up 3 (6 months post start-up of the intervention)	To evaluate the relapse rates of patients with former nasal decongestant overuse. For this study, relapse is defined as daily use of a nasal decongestant for more than 7 consecutive days after prior full withdrawal of the nasal decongestant

Secondary Outcome Measures

Name	Time	Method
Change from intervention baseline (part B) to week 12 of intervention in home measured PNIF as captured in diary on a fixed day every week	Assessed during screening period (2 weeks) and intervention period (12 weeks post start up intervention) on a weekly basis	To evaluate the change in nasal patency due to the withdrawal of the nasal decongestant
Change from intervention baseline (part B) to week 12 of intervention in PROMIS Sleep Disturbance Short form 8b scores (Raw scores range from 8 to 40, with higher scores indicating greater sleep disturbance)	Assessed at intervention baseline, follow-up 1 (6 weeks post start-up intervention), and follow-up 2 (12 weeks post start-up intervention)	To evaluate the change in sleep disturbance due to the withdrawal of the nasal decongestant
Change from intervention baseline (part B) to week 12 of intervention in Visual Analogue Scale (VAS) for nasal obstruction. Range 0mm - 100mm with higher values indicating worse outcome	Assessed at intervention baseline, follow-up 1 (6 weeks post start-up intervention), and follow-up 2 (12 weeks post start-up intervention)	To evaluate the change in nasal patency due to the withdrawal of the nasal decongestant
Change from intervention baseline (part B) to week 12 of intervention in hospital measured Peak Nasal Inspiratory Flow (PNIF)	Assessed at intervention baseline, follow-up 1 (6 weeks post start-up intervention), and follow-up 2 (12 weeks post start-up intervention)	To evaluate the change in nasal patency due to the withdrawal of the nasal decongestant
Change from intervention baseline (part B) to week 12 of intervention in Visual Analogue Scale (VAS) for nasal symptoms (nasal obstruction, runny nose, sneezing) as captured in the daily diary. Range 0mm-100mm with higher values indicating worse outcome	Assessed during screening period (2 weeks) and intervention period (12 weeks) on a daily basis	To evaluate the change in nasal patency due to the withdrawal of the nasal decongestant
Change from intervention baseline (part B) to week 12 of intervention in Rhinitis Control Assessment Test (RCAT) score (RCAT scores range from 6 to 30, with higher scores indicating greater rhinitis symptom control)	Assessed at intervention baseline, follow-up 1 (6 weeks post start-up intervention), and follow-up 2 (12 weeks post start-up intervention)	To evaluate the change in rhinitis control due to the withdrawal of the nasal decongestant
Change from intervention baseline (part B) to week 12 of intervention in Mini Rhinoconjunctivitis Quality of Life Questionnaire (miniRQLQ) (14 items, 0= no impairment to 6= severely impaired; higher scores indicate greater impairment of QoL)	Assessed at intervention baseline, follow-up 1 (6 weeks post start-up intervention), and follow-up 2 (12 weeks post start up intervention)	To evaluate the change in disease specific health-related quality of life (HRQoL) due to the withdrawal of the nasal decongestant
Change from baseline (part A) to week 12 of intervention in nasal endoscopy outcomes, assessed with our newly developed nasal endoscopy scoring sheet (containing Visual Analogue Scales (0-100mm), a colour scale and a nasal polyp scoring system)	Assessed at baseline (characterisation study) and at follow-up 2 (12 weeks post start-up intervention)	To evaluate the change in nasal endoscopy outcomes due to the withdrawal of the nasal decongestant

Trial Locations

Locations (1)

Ghent University Hospital; 🇧🇪 Ghent, Belgium