Clinical Trial: Iron Repletion in Chronic Cough and Iron Deficiency

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Effect of Iron Repletion in Women With Chronic Cough and Iron Deficiency

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: University of Turin, Italy

Current Primary Outcome:

  • Change in cough VAS [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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


Original Primary Outcome: Same as current

Current Secondary Outcome: Change in bronchial histamine threshold [ Time Frame: after 2 months empiric treatment and 2 months iron supplementation ]

Change in bronchial threshold, assessed as the histamine concentration causing 20% decrease from baseline of FEV1 (PC20FEV1), 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


Original Secondary Outcome: Same as current

Information By: University of Turin, Italy

Dates:
Date Received: December 29, 2011
Date Started: January 2002
Date Completion:
Last Updated: January 8, 2012
Last Verified: January 2012