CoughCIDNCT01507792
Iron Repletion in Chronic Cough and Iron Deficiency
A study testing iron sulphate and antiH1-histamine, proton pump inhibitor in people with Cough and Laryngeal Disease, run by University of Turin, Italy at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 15 to 70 years, women only
- Conditions the study is for
- Cough, Laryngeal Disease, Bronchial Disease
- What is being tested?
- iron sulphate and antiH1-histamine, proton pump inhibitor
- Type of treatment
- Pill or oral medicine
- How many people
- 22 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2002to Jan 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 70 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Respiratory Pathophysiology Clinic, ASO San Giovanni Battista
Turin, 10126
About this study
Official title: Effect of Iron Repletion in Women With Chronic Cough and Iron Deficiency
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.
Read the 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.
- Conditions
- Cough, Laryngeal Disease, Bronchial Disease, Iron Deficiency
- Being tested
- iron sulphate, antiH1-histamine, proton pump inhibitor
- Keywords
- Cough, Laryngismus, Bronchial spasm, Deficiency diseases
- Medical subject headings
- Cough, Laryngeal Diseases, Bronchial Diseases, Iron Deficiencies, Laryngismus, Bronchial Spasm, Deficiency Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iron sulphateDrug
1 or 2 330 mg/daily iron sulphate oral tablets
antiH1-histamine, proton pump inhibitorDrug
Also called AntiH1-histaminic drug = Loratadine 10 mg, Proton pump inhibitor = omeprazole 20 mg twice daily
This is not an intervention of interest, but it is a selection criterion to define unexplained cough, as suggested by cough guidelines.
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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
Measured: after 2 months empiric treatment and 2 months iron supplementation
Secondary outcomes (1)
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
Measured: after 2 months empiric treatment and 2 months iron supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2012 (estimated)
- Study startJan 2002
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CoughStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Collaborators
- Regione Piemonte
- Responsible party
- Principal investigator, Caterina Bucca, University of Turin, Italy
- Investigators
- Caterina B Bucca, MD, Principal investigator, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01507792
- Sponsor's protocol ID
- IRONCOUGH
- Acronym
- CID
- Status last verified
- Jan 2012
- First submitted
- 29 Dec 2011
- Last updated
- 11 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21167571Bucca 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.
PubMed 21248188Bucca 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.
PubMed 23067033
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Iron Repletion in Women With Chronic Cough and Iron Deficiency
- ClinicalTrials.gov ID
- NCT01507792
- Acronym / sponsor ID
- CID / IRONCOUGH
- Conditions
- Cough, Laryngeal Disease, Bronchial Disease, Iron Deficiency
- Keywords
- Cough, Laryngismus, Bronchial spasm, Deficiency diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Collaborators
- Regione Piemonte
- Study start
- Jan 2002
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 11 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 15 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iron sulphate1 or 2 330 mg/daily iron sulphate oral tablets | Drug | – |
| antiH1-histamine, proton pump inhibitorAlso: AntiH1-histaminic drug = Loratadine 10 mg, Proton pump inhibitor = omeprazole 20 mg twice dailyThis is not an intervention of interest, but it is a selection criterion to define unexplained cough, as suggested by cough guidelines. | Drug | – |
Primary outcome
Change in cough VAS
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)
Change in laryngeal histamine threshold
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
Change in cough histamine threshold
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
1 secondary outcome
Change in bronchial histamine threshold
Time frame: after 2 months empiric treatment and 2 months iron supplementation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2012.
- Background: PubMed 21167571Bucca 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.
- Background: PubMed 21248188Bucca 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.
- Derived from this study: PubMed 23067033Bucca 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caterina B Bucca, MD principal investigator
University of Turin, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iron sulphate and antiH1-histamine, proton pump inhibitor in people with Cough and Laryngeal Disease, run by University of Turin, Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cough VAS (time frame: after 2 months empiric treatment and 2 months iron supplementation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01507792, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2012.