Effect of Iron Repletion in Women With Chronic Cough and Iron Deficiency
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Change in cough VAS
研究概览
简要总结
Chronic cough is more frequent and severe in women than in men. Women often have decreased iron stores, due to menses and pregnancies. Aim of the study: to investigate if iron deficiency has a role in chronic cough by favouring airway hypersensitivity to inhaled irritants.
详细描述
Women with chronic cough and iron deficiency, cough unresponsive to empiric treatment (suggested by cough guidelines) with antiH1-histaminic drug plus proton pump inhibitor.
Cough VAS (score from 1,best, to 5, worst). Histamine inhalation challenge, performed to assess bronchial, laryngeal, and cough thresholds, performed by delivering doubling concentrations, from 0.5 mg/ml up to 32 mg/ml, by a nebulizer. After each dose FEV1, as bronchial index, maximum mid-inspiratory flow (MIF50) as laryngeal index, and coughs number are assessed. Bronchial threshold is the concentration causing 20% decrease in FEV1, laryngeal threshold that causing 25% decrease in MIF50, cough threshold that causing 5 coughs. Histamine hyperresponsiveness of the bronchi (BHR), larynx (LHR) and cough (coughHR) are defined for thresholds equal or below 8 mg/ml.
Histamine thresholds and cough VAS obtained in baseline, after cough empiric treatment with antiH1-histaminic and proton pump inhibitor, and after iron supplementation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Unexplained cough : no detectable trigger for chronic cough identified, such as persistent rhinitis, chronic sinusitis, gastroesophageal reflux disease and asthma.
- •no benefit by prior treatment with antiH1-histaminic drug and proton pump inhibitor.
- •iron deficiency.
- •normal lung function tests and chest radiography no relevant systemic disease.
- •no acute respiratory infection in the last eight weeks.
- •no pharmacological treatment in the last two weeks.
排除标准
- 未提供
结局指标
主要结局
Change in cough VAS
时间窗: after 2 months empiric treatment and 2 months iron supplementation
Changes in cough VAS after 2 months iron supplementation (1 mg/kg elemental iron, corresponding to one or two 330 mg iron sulphate tablets)compared to the value observed after empiric treatment Cough VAS from 0 (best= no cough) to 5 (worst = severe cough)
Change in laryngeal histamine threshold
时间窗: after 2 months empiric treatment and 2 months iron supplementation
Change in laryngeal threshold, assessed as the histamine concentration causing 25% decrease from baseline of MIF50 (PC25MIF50), after 2 months iron supplementation (1 mg/kg elemental iron, corresponding to one or two 330 mg iron sulphate tablets), compared to the value obtained after empiric treatment
Change in cough histamine threshold
时间窗: after 2 months empiric treatment and 2 months iron supplementation
Change in cough threshold, assessed as the histamine concentration causing 5 or more coughs(PC5cough), after 2 months iron supplementation (1 mg/kg elemental iron, corresponding to one or two 330 mg iron sulphate tablets), compared to the value obtained after empiric treatment
次要结局
- Change in bronchial histamine threshold(after 2 months empiric treatment and 2 months iron supplementation)
研究者
Caterina Bucca
Associate Professor of Internal Medicine
University of Turin, Italy