Characterisation and intervention study in patients with long-term use of nasal decongestants.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Universitair Ziekenhuis Gent

Participant type

Patients, Healthy volunteers

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Otorhinolaryngologic Diseases [C09]

Trial duration

5 Sep 2024 → 30 Apr 2025

Decision date (initial)

2024-09-05

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Ghent University Hospital

External identifiers

EU CT number

2024-516312-25-00

EudraCT number

2019-003254-91

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy

Primary objective: To evaluate the effectiveness (success rate) of a standardized, structured withdrawal plan based on Mometasone combined with motivational interviewing to reduce overuse of nasal decongestants.
Co-primary objective: To evaluate the relapse rates of patients with former nasal decongestant overuse.

Secondary objectives 5

1. To evaluate the change in rhinitis control due to the withdrawal of the nasal decongestant
2. To evaluate the change in nasal patency due to the withdrawal of the nasal decongestant
3. To evaluate the change in disease specific health-related quality of life (HRQoL) due to the withdrawal of the nasal decongestant
4. To evaluate the change in Sleep disturbance due to the withdrawal of the nasal decongestant
5. To evaluate the change in nasal endoscopy outcomes due to the withdrawal of the nasal decongestant

Conditions and MedDRA coding

rhinitis medicamentosa

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Part A-healthy volunteers: Aged 18 years or older
2. Part A-healthy volunteers: Sufficient knowledge of the Dutch language
3. Part A and B- participants with overuse of nasal decongestants: Aged 18 years or older
4. Part A and B- participants with overuse of nasal decongestants: Daily use of nasal decongestant for at least 6 months
5. Part A and B- participants with overuse of nasal decongestants: Sufficient knowledge of the Dutch language

Exclusion criteria 19

1. Part A-healthy volunteers: Subjective presence of nasal disease (i.e. the study subject indicates to experience any nasal symptoms, an occasional common cold not taken into account)
2. Part A-healthy volunteers: Established diagnosis of a nasal disorder (e.g. allergy, nasal polyps, …) or a positive allergy test (skin prick test or blood test)
3. Part A-healthy volunteers: Prior nasal surgery
4. Part A-healthy volunteers: Asthma
5. Part A-healthy volunteers: Use of an oral corticosteroid in the month prior to the screening visit (T-2)
6. Part A-healthy volunteers: Significant disease(s) that might interfere with the study, based on the judgement of the investigator.
7. Part A-healthy volunteers: 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 (T-2)
8. Part A-healthy volunteers: Other medication used to treat nasal symptoms (intranasal corticosteroids, oral or intranasal antihistamines, oral decongestants…)
9. Part A-healthy volunteers: History of rhinitis medicamentosa (either patient-reported long-term use of a nasal decongestant or a diagnosis of rhinitis medicamentosa)
10. Part A-healthy volunteers: Pregnancy, trying to become pregnant (during the duration of the study) or breastfeeding
11. Part A - participants with overuse of nasal decongestants: Pregnancy, trying to become pregnant (during the duration of the study) or breastfeeding
12. Part A - participants with overuse of nasal decongestants: Use of an oral corticosteroid in the month prior to the screening visit (T-2)
13. Part A - participants with overuse of nasal decongestants: Use of an oral decongestant in the week prior to the screening visit (T-2)
14. Part A - participants with overuse of nasal decongestants: Significant disease(s) that might interfere with the study, based on the judgement of the investigator
15. Part B- participants with overuse of nasal decongestants: Pregnancy, trying to become pregnant (during the duration of the study) or breastfeeding
16. Part B- participants with overuse of nasal decongestants: Glaucoma
17. Part B- participants with overuse of nasal decongestants: Use of an oral corticosteroid in the month prior to the start of the intervention (T1)
18. Part B- participants with overuse of nasal decongestants: Use of an oral decongestant in the week prior to the start of the intervention (T1)
19. Part B- participants with overuse of nasal decongestants: Significant disease(s) that might interfere with the study, based on the judgement of the investigator

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Proportion of study subjects with overuse of nasal decongestants able to completely withdraw the use of the nasal decongestant. For this study, complete withdrawal is defined as at least 7 consecutive days without any use of a nasal decongestant.
2. Co-primary end point: Proportion of study subjects who were able to completely withdraw the overuse of nasal decongestants at the followup 2 (T3, after 12 weeks of intervention) who relapsed by the time of follow-up 3 (T4, 6 months after the start-up of the intervention) 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 endpoints 5

1. Change from intervention baseline (T1) in Rhinitis Control Assessment Test (RCAT) score
2. Change from intervention baseline (T1) in home measured Peak Nasal Inspiratory Flow (PNIF) as captured in the daily diary on a fixed day every week / Change from intervention baseline (T1) in hospital measured PNIF / Change from intervention baseline (T1) in visual analogue scale (VAS) for nasal obstruction / Change from intervention baseline (T1) in nasal symptom score(s) as captured in the daily diary
3. Change from intervention baseline (T1) in Mini Rhinoconjunctivitis Quality of Life Questionnaire (miniRQLQ)
4. Change from intervention baseline (T1) in PROMIS Sleep Disturbance short form 8b
5. Change in nasal endoscopy outcomes

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Universitair Ziekenhuis Gent

Sponsor organisation

Universitair Ziekenhuis Gent

Address

Corneel Heymanslaan 10

City

Gent

Postcode

9000

Country

Belgium

Scientific contact point

Organisation

Universitair Ziekenhuis Gent

Contact name

Sophie Scheire

Public contact point

Organisation

Universitair Ziekenhuis Gent

Contact name

Sophie Scheire

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications