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Completed

NCT Number: NCT01507792

Iron Repletion in Chronic Cough and Iron Deficiency

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

iron sulphate

Drug

1 or 2 330 mg/daily iron sulphate oral tablets

antiH1-histamine, proton pump inhibitor

Drug

This is not an intervention of interest, but it is a selection criterion to define unexplained cough, as suggested by cough guidelines.

Other names: AntiH1-histaminic drug = Loratadine 10 mg, Proton pump inhibitor = omeprazole 20 mg twice daily

Primary outcomes

  1. 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)

  2. 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

  3. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Turin, Italy

Other

Collaborators

  • Regione Piemonte

Registry information

Official study title

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

Acronym: CID

Important dates

Study start
2002
Primary completion
2011
Study completion
2011
First posted
Jan 11, 2012
Registry last updated
Jan 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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