Respiratory Pathophysiology Clinic, ASO San Giovanni Battista
Turin, 10126, Italy
NCT Number: NCT01507792
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.
Looking for future studies?
Notify Me15 year–70 year
Female
Interventional
Not applicable
Turin, 10126, Italy
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
1 or 2 330 mg/daily iron sulphate oral tablets
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
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)
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
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
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
University of Turin, Italy
Other
Effect of Iron Repletion in Women With Chronic Cough and Iron Deficiency
Acronym: CID
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT01922700
Bronchial Diseases, Bronchial Spasm
Srinagar, Jammu and Kashmir, India
View Trial DetailsNCT00925613
Apnea, Cough
Montreal, Quebec, Canada
View Trial DetailsNCT05599191
Chronic Cough, Cough
Jasper, Alabama, United States
View Trial DetailsNCT06716645
Common Cold, Cough
New York, United States
View Trial Details