Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2025-12-27 @ 12:32 AM
Study NCT ID:
NCT01507792
Status:
COMPLETED
Last Update Posted:
2012-01-11
First Post:
2011-12-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Iron Repletion in Chronic Cough and Iron Deficiency
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003371', 'term': 'Cough'}, {'id': 'D007818', 'term': 'Laryngeal Diseases'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D000090463', 'term': 'Iron Deficiencies'}, {'id': 'D007826', 'term': 'Laryngismus'}, {'id': 'D001986', 'term': 'Bronchial Spasm'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D064706', 'term': 'Vocal Cord Dysfunction'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007505', 'term': 'Iron-Dextran Complex'}, {'id': 'D054328', 'term': 'Proton Pump Inhibitors'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003911', 'term': 'Dextrans'}, {'id': 'D005936', 'term': 'Glucans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-08', 'studyFirstSubmitDate': '2011-12-29', 'studyFirstSubmitQcDate': '2012-01-08', 'lastUpdatePostDateStruct': {'date': '2012-01-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in cough VAS', 'timeFrame': 'after 2 months empiric treatment and 2 months iron supplementation', 'description': '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)'}, {'measure': 'Change in laryngeal histamine threshold', 'timeFrame': 'after 2 months empiric treatment and 2 months iron supplementation', 'description': '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'}, {'measure': 'Change in cough histamine threshold', 'timeFrame': 'after 2 months empiric treatment and 2 months iron supplementation', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Change in bronchial histamine threshold', 'timeFrame': 'after 2 months empiric treatment and 2 months iron supplementation', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cough', 'Laryngismus', 'Bronchial spasm', 'Deficiency diseases'], 'conditions': ['Cough', 'Laryngeal Disease', 'Bronchial Disease', 'Iron Deficiency']}, 'referencesModule': {'references': [{'pmid': '21167571', 'type': 'BACKGROUND', '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.'}, {'pmid': '21248188', 'type': 'BACKGROUND', '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.'}, {'pmid': '23067033', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Women with chronic cough and iron deficiency, cough unresponsive to empiric treatment (suggested by cough guidelines) with antiH1-histaminic drug plus proton pump inhibitor.\n\nCough 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.\n\nHistamine thresholds and cough VAS obtained in baseline, after cough empiric treatment with antiH1-histaminic and proton pump inhibitor, and after iron supplementation.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Unexplained cough : no detectable trigger for chronic cough identified, such as persistent rhinitis, chronic sinusitis, gastroesophageal reflux disease and asthma.\n* no benefit by prior treatment with antiH1-histaminic drug and proton pump inhibitor.\n* iron deficiency.\n* normal lung function tests and chest radiography no relevant systemic disease.\n* no acute respiratory infection in the last eight weeks.\n* no pharmacological treatment in the last two weeks.\n\nExclusion Criteria:'}, 'identificationModule': {'nctId': 'NCT01507792', 'acronym': 'CID', 'briefTitle': 'Iron Repletion in Chronic Cough and Iron Deficiency', 'organization': {'class': 'OTHER', 'fullName': 'University of Turin, Italy'}, 'officialTitle': 'Effect of Iron Repletion in Women With Chronic Cough and Iron Deficiency', 'orgStudyIdInfo': {'id': 'IRONCOUGH'}}, 'armsInterventionsModule': {'interventions': [{'name': 'iron sulphate', 'type': 'DRUG', 'description': '1 or 2 330 mg/daily iron sulphate oral tablets'}, {'name': 'antiH1-histamine, proton pump inhibitor', 'type': 'DRUG', 'otherNames': ['AntiH1-histaminic drug = Loratadine 10 mg', 'Proton pump inhibitor = omeprazole 20 mg twice daily'], 'description': 'This is not an intervention of interest, but it is a selection criterion to define unexplained cough, as suggested by cough guidelines.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10126', 'city': 'Turin', 'country': 'Italy', 'facility': 'Respiratory Pathophysiology Clinic, ASO San Giovanni Battista', 'geoPoint': {'lat': 45.07049, 'lon': 7.68682}}], 'overallOfficials': [{'name': 'Caterina B Bucca, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Turin, Italy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Turin, Italy', 'class': 'OTHER'}, 'collaborators': [{'name': 'Regione Piemonte', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Internal Medicine', 'investigatorFullName': 'Caterina Bucca', 'investigatorAffiliation': 'University of Turin, Italy'}}}}