NCT03093363已完成不适用
Study of the Impact of a Hospital Pharmacist's Intervention in Collaboration With Pneumologists on Bronchial Inflammation of Outpatient Asthmatic Patients Seen in University Hospital of Liege
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 主要终点
- Change from Baseline FENO (fractional exhaled nitric oxide) at 3 months
研究概览
简要总结
The impact of a pharmacist's intervention on asthma control has now been well demonstrated, but its effect on inflammatory markers of FENO (Fractional exhaled nitric oxide) in asthmatic patients has been little studied in the literature. The aim of this study is to investigate the impact of a pharmacist's intervention on FENO in patients seen in clinical practice by a pneumologist in a secondary university center.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult asthmatics (definition of asthma: FEV1 [forced expiratory volume in 1 second] reversibility of at least 12% and 200 mL after 400 mcg of salbutamol and/or PC20M [provocative concentration of methacholine causing a 20% fall in FEV1]<16 mg/mL)
- •unchanged or increased dose of inhaled corticosteroids prescribed by the pneumologist at the visit
- •FENO (fractional exhaled nitric oxide) > or = 25 ppb
排除标准
- •Treatment with oral corticosteroids to treat an asthma exacerbation within 4 weeks before the visit with the pneumologist
- •Exclusion Criteria during the study:
- •Change of the dose of ICS (inhaled corticosteroids) during the follow-up of 3 months after the pharmacist's intervention
- •Severe asthma exacerbation requiring oral corticosteroids within the 4 weeks before the follow-up visit (3 months after the pharmacist's intervention)
研究组 & 干预措施
Intervention group
Other
Asthmatic patients with the pharmacist's intervention
干预措施: Pharmacist's intervention (Other)
Control group
Other
Asthmatic patients without the pharmacist's intervention (only questionnaires)
干预措施: Questionnaires for control group (Other)
结局指标
主要结局
Change from Baseline FENO (fractional exhaled nitric oxide) at 3 months
时间窗: 3 months
Fractional exhaled nitric oxide
次要结局
- Change from Baseline FEV1 (forced expiratory volume in 1 second) at 3 months(3 months)
- Change from Baseline FVC (forced vital capacity) at 3 months(3 months)
- Change from Baseline FEV1/FVC at 3 months(3 months)
- Change from Baseline ACQ (Asthma Control Questionnaire) at 3 months(3 months)
- Change from Baseline ACT (Asthma Control Test) at 3 months(3 months)
- Change from Baseline miniAQLQ (Asthma Quality of Life Questionnaire) at 3 months(3 months)
- Change from Baseline MARS (Medication Adherence Report Scale) at 3 months(3 months)
- Change from Baseline MRA (Medication Refill Adherence) at 3 months(3 months)
- Change from Baseline score of the inhalation technique at 3 months(3 months)
- Change from Baseline number of severe exacerbations (during the 3 previous months) at 3 months(3 months)
- Change from Baseline smoking status at 3 months(3 months)
- Satisfaction of patients with the pharmacist's intervention, with a scale from 0 to 10(3 months after intervention)
- Changes in lifestyle related to asthma (free text field to complete by the patient)(3 months after intervention)
研究者
Renaud Louis
Professor, MD, PhD
University of Liege
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