Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Iron Repletion in Chronic Cough and Iron Deficiency (CID)

This study has been completed.
Sponsor:
Collaborator:
Regione Piemonte
Information provided by (Responsible Party):
Caterina Bucca, University of Turin, Italy
ClinicalTrials.gov Identifier:
NCT01507792
First received: December 29, 2011
Last updated: January 8, 2012
Last verified: January 2012

December 29, 2011
January 8, 2012
January 2002
January 2011   (final data collection date for primary outcome measure)
  • Change in cough VAS [ Time Frame: after 2 months empiric treatment and 2 months iron supplementation ] [ Designated as safety issue: No ]
    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 [ Time Frame: after 2 months empiric treatment and 2 months iron supplementation ] [ Designated as safety issue: No ]
    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 [ Time Frame: after 2 months empiric treatment and 2 months iron supplementation ] [ Designated as safety issue: No ]
    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
Same as current
Complete list of historical versions of study NCT01507792 on ClinicalTrials.gov Archive Site
Change in bronchial histamine threshold [ Time Frame: after 2 months empiric treatment and 2 months iron supplementation ] [ Designated as safety issue: No ]
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
Same as current
Not Provided
Not Provided
 
Iron Repletion in Chronic Cough and Iron Deficiency
Effect of Iron Repletion in Women With 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.

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cough
  • Laryngeal Disease
  • Bronchial Disease
  • Iron Deficiency
  • 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.
    Other Names:
    • AntiH1-histaminic drug = Loratadine 10 mg
    • Proton pump inhibitor = omeprazole 20 mg twice daily
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
January 2011
January 2011   (final data collection date for primary outcome measure)

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:

Female
15 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01507792
IRONCOUGH
No
Caterina Bucca, University of Turin, Italy
University of Turin, Italy
Regione Piemonte
Principal Investigator: Caterina B Bucca, MD University of Turin
University of Turin, Italy
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP