Cough Clinical Trial
Official title:
Effect of Iron Repletion in Women With Chronic Cough and Iron Deficiency
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.
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.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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