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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
History of Changes
  Purpose

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.


Condition Intervention
Cough
Laryngeal Disease
Bronchial Disease
Iron Deficiency
 Drug: iron sulphate
Drug: antiH1-histamine, proton pump inhibitor

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Iron Repletion in Women With Chronic Cough and Iron Deficiency

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Turin, Italy:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 22
Study Start Date: January 2002
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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.

  Eligibility

Ages Eligible for Study:   15 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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:

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01507792

Locations
Italy
Respiratory Pathophysiology Clinic, ASO San Giovanni Battista
Turin, Italy, 10126
Sponsors and Collaborators
University of Turin, Italy
Regione Piemonte
Investigators
Principal Investigator: Caterina B Bucca, MD University of Turin
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Caterina Bucca, Associate Professor of Internal Medicine, University of Turin, Italy
ClinicalTrials.gov Identifier: NCT01507792     History of Changes
Other Study ID Numbers: IRONCOUGH
Study First Received: December 29, 2011
Last Updated: January 8, 2012
Health Authority: Italy: National Institute of Health

Keywords provided by University of Turin, Italy:
Cough
Laryngismus
Bronchial spasm
Deficiency diseases

Additional relevant MeSH terms:
Bronchial Diseases
Cough
Laryngeal Diseases
Anemia, Iron-Deficiency
Respiratory Tract Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms
Otorhinolaryngologic Diseases
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
 Histamine
Iron
Proton Pump Inhibitors
Histamine Agonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Trace Elements
Micronutrients
Growth Substances
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 22, 2013