Iron Repletion in Chronic Cough and Iron Deficiency

NCT01507792 | Completed

• 1 other identifier: IRONCOUGH
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cough; Laryngeal Disease; Bronchial Disease; Iron Deficiency

Keywords

Cough; Laryngismus; Bronchial spasm; Deficiency diseases

Outcome Measures

Primary Outcomes (3)

• Change in cough VAS

  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

  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

  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 Outcomes (1)

• Change in bronchial histamine threshold

  after 2 months empiric treatment and 2 months iron supplementation

Interventions

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.

Also known as: AntiH1-histaminic drug = Loratadine 10 mg, Proton pump inhibitor = omeprazole 20 mg twice daily

Eligibility Criteria

• Age: 15 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Turin, Italy: lead
• Regione Piemonte: collaborator

Study Sites (1)

Respiratory Pathophysiology Clinic, ASO San Giovanni Battista

Turin, 10126, Italy

Location

Related Publications (3)

• Bucca CB, Bugiani M, Culla B, Guida G, Heffler E, Mietta S, Moretto A, Rolla G, Brussino L. Chronic cough and irritable larynx. J Allergy Clin Immunol. 2011 Feb;127(2):412-9. doi: 10.1016/j.jaci.2010.10.038. Epub 2010 Dec 16.

  PMID: 21167571 BACKGROUND

• Bucca CB, Culla B, Guida G, Sciascia S, Bellone G, Moretto A, Heffler E, Bugiani M, Rolla G, Brussino L. Unexplained chronic cough and vitamin B-12 deficiency. Am J Clin Nutr. 2011 Mar;93(3):542-8. doi: 10.3945/ajcn.110.000802. Epub 2011 Jan 19.

  PMID: 21248188 BACKGROUND

• Bucca C, Culla B, Brussino L, Ricciardolo FL, Cicolin A, Heffler E, Bugiani M, Rolla G. Effect of iron supplementation in women with chronic cough and iron deficiency. Int J Clin Pract. 2012 Nov;66(11):1095-100. doi: 10.1111/ijcp.12001.

  PMID: 23067033 DERIVED

MeSH Terms

Conditions

Cough; Laryngeal Diseases; Bronchial Diseases; Iron Deficiencies; Laryngismus; Bronchial Spasm; Deficiency Diseases

Interventions

Iron-Dextran Complex; Proton Pump Inhibitors

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Otorhinolaryngologic Diseases; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Vocal Cord Dysfunction; Malnutrition; Nutrition Disorders

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Dextrans; Glucans; Polysaccharides; Carbohydrates; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Caterina B Bucca, MD

  University of Turin, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Internal Medicine

Study Record Dates

• First Submitted: December 29, 2011
• First Posted: January 11, 2012
• Study Start: January 1, 2002
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: January 11, 2012

Record last verified: 2012-01

Locations

IT (1)