Iron Repletion in Chronic Cough and Iron Deficiency (CID)

January 8, 2012 updated by: Caterina Bucca, University of Turin, Italy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Turin, Italy, 10126
        • Respiratory Pathophysiology Clinic, ASO San Giovanni Battista

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 70 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
after 2 months empiric treatment and 2 months iron supplementation
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
after 2 months empiric treatment and 2 months iron supplementation
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
after 2 months empiric treatment and 2 months iron supplementation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
after 2 months empiric treatment and 2 months iron supplementation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Turin, Italy

Collaborators

Regione Piemonte

Investigators

  • Principal Investigator: Caterina B Bucca, MD, University of Turin, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2002

Primary Completion (ACTUAL)

January 1, 2011

Study Completion (ACTUAL)

January 1, 2011

Study Registration Dates

First Submitted

December 29, 2011

First Submitted That Met QC Criteria

January 8, 2012

First Posted (ESTIMATE)

January 11, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

January 11, 2012

Last Update Submitted That Met QC Criteria

January 8, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRONCOUGH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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