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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-516312-25-00
Acronym
AGO/2019/005
Enrollment
135
Registered
2024-09-05
Start date
2024-09-05
Completion date
2025-04-30
Last updated
2024-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

rhinitis medicamentosa

Brief summary

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., 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.

Detailed description

Change from intervention baseline (T1) in Rhinitis Control Assessment Test (RCAT) score, 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, Change from intervention baseline (T1) in Mini Rhinoconjunctivitis Quality of Life Questionnaire (miniRQLQ), Change from intervention baseline (T1) in PROMIS Sleep Disturbance short form 8b, Change in nasal endoscopy outcomes

Interventions

Sponsors

Universitair Ziekenhuis Gent
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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., 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

MeasureTime frame
Change from intervention baseline (T1) in Rhinitis Control Assessment Test (RCAT) score, 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, Change from intervention baseline (T1) in Mini Rhinoconjunctivitis Quality of Life Questionnaire (miniRQLQ), Change from intervention baseline (T1) in PROMIS Sleep Disturbance short form 8b, Change in nasal endoscopy outcomes

Countries

Belgium

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026