E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
non-allergic drug-induced disease of the nose |
niet-allergische geneesmiddel-geïnduceerde aandoening van de neus |
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E.1.1.2 | Therapeutic area | Diseases [C] - Ear, nose and throat diseases [C09] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives: - To evaluate the change in rhinitis control due to the withdrawal of the nasal decongestant; - To evaluate the change in nasal patency due to the withdrawal of the nasal decongestant; - To evaluate the change in disease specific health-related quality of life (HRQoL) due to the withdrawal of the nasal decongestant; - To evaluate the change in Sleep disturbance due to the withdrawal of the nasal decongestant; - To evaluate the change in nasal endoscopy outcomes due to the withdrawal of the nasal decongestant.
Secondary exploratory objective: To assess the effect of withdrawal on exploratory biomarkers of inflammation and immune response in blood samples and nasal secretions.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Part A: healthy volunteers 1. Aged 18 years or older 2. Sufficient knowledge of the Dutch language
Part A and B: participants with overuse of nasal decongestants 1. Aged 18 years or older 2. Daily use of nasal decongestant for at least 6 months 3. Sufficient knowledge of the Dutch language |
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E.4 | Principal exclusion criteria |
Part A: healthy volunteers 1. 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. Established diagnosis of a nasal disorder (e.g. allergy, nasal polyps, …) or a positive allergy test (skin prick test or blood test) 3. Prior nasal surgery 4. Asthma 5. Use of an oral corticosteroid in the month prior to the screening visit (T-2) 6. Significant disease(s) that might interfere with the study, based on the judgement of the investigator. 7. 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. Other medication used to treat nasal symptoms (intranasal corticosteroids, oral or intranasal antihistamines, oral decongestants…) 9. History of rhinitis medicamentosa (either patient-reported long-term use of a nasal decongestant or a diagnosis of rhinitis medicamentosa) 10. Pregnancy, trying to become pregnant (during the duration of the study) or breastfeeding
Part A: participants with overuse of nasal decongestants 1. Pregnancy, trying to become pregnant (during the duration of the study) or breastfeeding 2. Use of an oral corticosteroid in the month prior to the screening visit (T-2) 3. Use of an oral decongestant in the week prior to the screening visit (T-2) 4. Significant disease(s) that might interfere with the study, based on the judgement of the investigator
Part B: participants with overuse of nasal decongestants 1. Pregnancy, trying to become pregnant (during the duration of the study) or breastfeeding 2. Glaucoma 3. Use of an oral corticosteroid in the month prior to the start of the intervention (T1) 4. Use of an oral decongestant in the week prior to the start of the intervention (T1) 5. Significant disease(s) that might interfere with the study, based on the judgement of the investigator |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary end point: Proportion of study subjects with overuse of nasal decongestants able to completely withdraw the use of the nasal decongestant.
Co-primary end point: Proportion of study subjects who were able to completely withdraw the overuse of nasal decongestants at the follow-up 2 (T3, after 12 weeks of intervention) who relapsed by the time of follow-up 3 (T4). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Primary end point: Follow-up 2 (T3, after 12 weeks of intervention).
Co-primary end point: Telephone follow-up (= follow-up 3) (T4, 6 months after the start-up of the intervention). |
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E.5.2 | Secondary end point(s) |
Secondary end points: - 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.
Secondary exploratory end point : Change from baseline (T0) in exploratory biomarkers of inflammation and immune response in blood samples and nasal secretions. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Secondary end points: - Intervention baseline (T1), follow-up 1 (T2, after 6 weeks of intervention) and follow-up 2 (T3, after 12 weeks of intervention); - Weekly measurements during: Screening period (2 weeks) and Intervention period (12 weeks) / Intervention baseline (T1), follow-up 1 (T2) and follow-up 2 (T3) / Ditto / Daily recordings of VAS score during: Screening period (2 weeks) and Intervention period (12 weeks); - Intervention baseline (T1), follow-up 1 (T2) and follow-up 2 (T3); - Ditto; - Baseline (T0, characterisation study) and follow-up 2 (T3, after 12 weeks of intervention).
Secondary exploratory end point: Baseline (T0 characterisation study) and follow-up 2 (T3, after 12 weeks of intervention).
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |