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
| Type | Name | Description |
|---|---|---|
| DRUG | iron sulphate | 1 or 2 330 mg/daily iron sulphate oral tablets |
| DRUG | antiH1-histamine, proton pump inhibitor | This 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.