Iron Repletion in Chronic Cough and Iron Deficiency (CID)

University of Turin

Status: Completed

Conditions: Iron Deficiency; Laryngeal Disease; Cough; Bronchial Disease

Treatments: Drug: antiH1-histamine, proton pump inhibitor; Drug: iron sulphate

Study type: Interventional

Funder types: Other

Identifiers

NCT01507792

IRONCOUGH

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: Female

Ages: 15 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Exclusion Criteria:

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)