Characterisation and intervention study in patients with long-term use of nasal decongestants.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Characterisation and intervention study in patients with long-term use of nasal decongestants
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Part A-healthy volunteers: Aged 18 years or older
- •Part A-healthy volunteers: Sufficient knowledge of the Dutch language
- •Part A and B- participants with overuse of nasal decongestants: Aged 18 years or older
- •Part A and B- participants with overuse of nasal decongestants: Daily use of nasal decongestant for at least 6 months
- •Part A and B- participants with overuse of nasal decongestants: Sufficient knowledge of the Dutch language
排除标准
- •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)
- •Part A-healthy volunteers: Pregnancy, trying to become pregnant (during the duration of the study) or breastfeeding
- •Part A - participants with overuse of nasal decongestants: Pregnancy, trying to become pregnant (during the duration of the study) or breastfeeding
- •Part A - participants with overuse of nasal decongestants: Use of an oral corticosteroid in the month prior to the screening visit (T-2)
- •Part A - participants with overuse of nasal decongestants: Use of an oral decongestant in the week prior to the screening visit (T-2)
- •Part A - participants with overuse of nasal decongestants: Significant disease(s) that might interfere with the study, based on the judgement of the investigator
- •Part B- participants with overuse of nasal decongestants: Pregnancy, trying to become pregnant (during the duration of the study) or breastfeeding
- •Part B- participants with overuse of nasal decongestants: Glaucoma
- •Part B- participants with overuse of nasal decongestants: Use of an oral corticosteroid in the month prior to the start of the intervention (T1)
- •Part B- participants with overuse of nasal decongestants: Use of an oral decongestant in the week prior to the start of the intervention (T1)
- •Part B- participants with overuse of nasal decongestants: Significant disease(s) that might interfere with the study, based on the judgement of the investigator
- •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)
- •Part A-healthy volunteers: Prior nasal surgery
- •Part A-healthy volunteers: Asthma
- •Part A-healthy volunteers: Use of an oral corticosteroid in the month prior to the screening visit (T-2)
- •Part A-healthy volunteers: Significant disease(s) that might interfere with the study, based on the judgement of the investigator.
- •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)
- •Part A-healthy volunteers: Other medication used to treat nasal symptoms (intranasal corticosteroids, oral or intranasal antihistamines, oral decongestants…)
- •Part A-healthy volunteers: History of rhinitis medicamentosa (either patient-reported long-term use of a nasal decongestant or a diagnosis of rhinitis medicamentosa)
结局指标
主要结局
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.
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.
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.
次要结局
- 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
研究者
Sophie Scheire
Scientific
Universitair Ziekenhuis Gent