Clinical Trials Directory

Trials / Completed

CompletedNCT01507792

Iron Repletion in Chronic Cough and Iron Deficiency

Effect of Iron Repletion in Women With Chronic Cough and Iron Deficiency

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
22 (actual)
Sponsor
University of Turin, Italy · Academic / Other
Sex
Female
Age
15 Years – 70 Years
Healthy volunteers
Not accepted

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 description

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.

Conditions

Interventions

TypeNameDescription
DRUGiron sulphate1 or 2 330 mg/daily iron sulphate oral tablets
DRUGantiH1-histamine, proton pump inhibitorThis is not an intervention of interest, but it is a selection criterion to define unexplained cough, as suggested by cough guidelines.

Timeline

Start date
2002-01-01
Primary completion
2011-01-01
Completion
2011-01-01
First posted
2012-01-11
Last updated
2012-01-11

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT01507792. Inclusion in this directory is not an endorsement.