Cough, Laryngeal Disease, Bronchial Disease, Iron Deficiency
Conditions
Keywords
Cough, Laryngismus, Bronchial spasm, Deficiency diseases
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 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.
Interventions
DRUGiron sulphate
1 or 2 330 mg/daily iron sulphate oral tablets
DRUGantiH1-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.
Sponsors
Regione Piemonte
University of Turin, Italy
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in cough VAS | 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 | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in bronchial histamine threshold | 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 |
Countries
Italy
Outcome results
None listed