Clinical trial NCT01507792: Iron Repletion in Chronic Cough and Iron Deficiency
Official title: Effect of Iron Repletion in Women With Chronic Cough and Iron Deficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cough
Laryngeal Disease
Bronchial Disease
Iron Deficiency
Keywords: Cough
Laryngismus
Bronchial spasm
Deficiency diseases
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
Collaborators: name: Regione Piemonte
First posted: 2012-01-11
Enrollment: 22
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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:

Primary outcomes:
measure: Change in cough VAS
timeFrame: after 2 months empiric treatment and 2 months iron supplementation
measure: Change in laryngeal histamine threshold
timeFrame: after 2 months empiric treatment and 2 months iron supplementation
measure: Change in cough histamine threshold
timeFrame: after 2 months empiric treatment and 2 months iron supplementation
Secondary outcomes:
measure: Change in bronchial histamine threshold
timeFrame: after 2 months empiric treatment and 2 months iron supplementation
Other outcomes:
Locations:
city: Turin
country: Italy
facility: Respiratory Pathophysiology Clinic, ASO San Giovanni Battista
Study officials:
affiliation: University of Turin, Italy
name: Caterina B Bucca, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
citation: 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.