Iron Repletion in Chronic Cough and Iron Deficiency

Cough Clinical Trial

— CID  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01507792
• Other study ID #: IRONCOUGH
• Status: Completed
• Phase: N/A
• First received: December 29, 2011
• Last updated: January 8, 2012
• Start date: January 2002
• Est. completion date: January 2011

Study information

• Verified date: January 2012
• Source: University of Turin, Italy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Institute of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 70 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Bronchial Disease
• Bronchial Diseases
• Cough
• Iron Deficiency
• Laryngeal Disease
• Laryngeal Diseases

Intervention

Drug:
• iron sulphate
1 or 2 330 mg/daily iron sulphate oral tablets
• 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.

Locations

Country	Name	City	State
Italy	Respiratory Pathophysiology Clinic, ASO San Giovanni Battista	Turin

Sponsors (2)

Lead Sponsor	Collaborator
University of Turin, Italy	Regione Piemonte

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Change in bronchial histamine threshold	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	No