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

Primary Purpose

Rhinitis Medicamentosa

Status

Recruiting

Phase

Phase 4

Locations

Belgium

Study Type

Interventional

Intervention

Mometasone Furoate

About this trial

This is an interventional treatment trial for Rhinitis Medicamentosa focused on measuring non-allergic drug-induced rhinitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Ghent University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Healthy Volunteers

Patients with long-term use of nasal decongestants

Arm Description

This study arm will only participate in part A of the study (Characterisation study) and thus will not receive the study drug. A maximum of 35 healthy volunteers will be included in this study arm.

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.

Outcomes

Primary Outcome Measures

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.

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).

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

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)

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 home measured PNIF as captured in diary on a fixed day every week

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)

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 obstruction. Range 0mm - 100mm with higher values indicating worse outcome

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

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 Mini Rhinoconjunctivitis Quality of Life Questionnaire (miniRQLQ) (14 items, 0= no impairment to 6= severely impaired; higher scores indicate greater impairment of QoL)

To evaluate the change in disease specific health-related quality of life (HRQoL) 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)

To evaluate the change in sleep disturbance 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)

To evaluate the change in nasal endoscopy outcomes due to the withdrawal of the nasal decongestant

Full Information

NCT ID

NCT04898764

First Posted

October 16, 2020

Last Updated

November 16, 2022

Sponsor

University Hospital, Ghent

1. Study Identification

Unique Protocol Identification Number

NCT04898764

Brief Title

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

Official Title

Characterisation and Intervention Study in Patients With Long-term Use of Nasal Decongestants

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

October 21, 2020 (Actual)

Primary Completion Date

October 20, 2023 (Anticipated)

Study Completion Date

October 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Ghent

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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: 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rhinitis Medicamentosa

Keywords

non-allergic drug-induced rhinitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

135 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Healthy Volunteers

Arm Type

No Intervention

Arm Description

This study arm will only participate in part A of the study (Characterisation study) and thus will not receive the study drug. A maximum of 35 healthy volunteers will be included in this study arm.

Arm Title

Patients with long-term use of nasal decongestants

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Mometasone Furoate

Intervention Description

Mometasone furoate nasal spray suspension, 50µg/actuation

Primary Outcome Measure Information:

Title

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.

Description

Time Frame

Assessed at follow-up 2 (12 weeks post start up intervention)

Title

Description

Time Frame

Assessed at follow-up 3 (6 months post start-up of the intervention)

Secondary Outcome Measure Information:

Title

Description

To evaluate the change in rhinitis control due to the withdrawal of the nasal decongestant

Time Frame

Assessed at intervention baseline, follow-up 1 (6 weeks post start-up intervention), and follow-up 2 (12 weeks post start-up intervention)

Title

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

Description

To evaluate the change in nasal patency due to the withdrawal of the nasal decongestant

Time Frame

Assessed during screening period (2 weeks) and intervention period (12 weeks post start up intervention) on a weekly basis

Title

Change from intervention baseline (part B) to week 12 of intervention in hospital measured Peak Nasal Inspiratory Flow (PNIF)

Description

To evaluate the change in nasal patency due to the withdrawal of the nasal decongestant

Time Frame

Assessed at intervention baseline, follow-up 1 (6 weeks post start-up intervention), and follow-up 2 (12 weeks post start-up intervention)

Title

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

Description

To evaluate the change in nasal patency due to the withdrawal of the nasal decongestant

Time Frame

Assessed at intervention baseline, follow-up 1 (6 weeks post start-up intervention), and follow-up 2 (12 weeks post start-up intervention)

Title

Description

To evaluate the change in nasal patency due to the withdrawal of the nasal decongestant

Time Frame

Assessed during screening period (2 weeks) and intervention period (12 weeks) on a daily basis

Title

Description

To evaluate the change in disease specific health-related quality of life (HRQoL) due to the withdrawal of the nasal decongestant

Time Frame

Assessed at intervention baseline, follow-up 1 (6 weeks post start-up intervention), and follow-up 2 (12 weeks post start up intervention)

Title

Description

To evaluate the change in sleep disturbance due to the withdrawal of the nasal decongestant

Time Frame

Assessed at intervention baseline, follow-up 1 (6 weeks post start-up intervention), and follow-up 2 (12 weeks post start-up intervention)

Title

Description

To evaluate the change in nasal endoscopy outcomes due to the withdrawal of the nasal decongestant

Time Frame

Assessed at baseline (characterisation study) and at follow-up 2 (12 weeks post start-up intervention)

Other Pre-specified Outcome Measures:

Title

Change from baseline (part A) to week 12 of intervention in exploratory biomarkers of inflammation and immune response in blood samples and nasal secretions (multiplex analysis of cytokines)

Description

To assess the effect of withdrawal on exploratory biomarkers of inflammation and immune response in blood samples and nasal secretions

Time Frame

Assessed at baseline (characterisation study) and at follow-up 2 (12 weeks of intervention)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sophie Scheire, MPharm

Phone

003292648073

sophie.scheire@ugent.be

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Philippe Gevaert, MD, PhD

Organizational Affiliation

Ghent University Hospital, Ghent, Belgium

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ghent University Hospital

City

Ghent

ZIP/Postal Code

9000

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sophie Scheire

First Name & Middle Initial & Last Name & Degree

Philippe Gevaert

12. IPD Sharing Statement

Learn more about this trial

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

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