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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-A00846-49 | Other Identifier | AFSSAPS |
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| Name | Class |
|---|---|
| Syntara | INDUSTRY |
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Chronic cough is defined by its persistence beyond 8 weeks. Many conditions can explain the existence of a bronchial inflammation. In the management of chronic cough, the search for bronchial hyperreactivity (HRB) is recommended. The treatment relies primarily on the prescription of inhaled corticosteroids. It has been shown recently that the existence of an HRB with Methacholine (bronchial provocation test used in routine) does predict the effectiveness of inhaled corticosteroid treatment in no more than 50% of cases.
It is now possible to assess the bronchial inflammation by rapid, non-invasive and reproducible tests such that the fraction of exhaled nitric oxide (FeNO) and bronchial provocation test with mannitol. In a retrospective study, it was shown that an increased value of FeNO (cut-off > 35 ppb) predicts a positive response to treatment with a sensitivity of 90% and a specificity of 80%.
The purpose of this study is to show that the use of the prospective value of exhaled NO can predict response to treatment with inhaled corticosteroids in adult with chronic cough. In addition we will assess the interest of the prognosis of bronchial provocation test with mannitol in this indication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bronchial provocation test with mannitol | Experimental | Patients referred for evaluation of a chronic cough (without treatment or after stopping inhaled corticosteroids for 2 weeks) will perform a measure of FeNO, a bronchial provocation test with mannitol, will fill out a questionnaire of quality of life for the cough (Leicester Cough Questionnaire) and the intensity of coughing on a 10-cm visual scale. After 6 weeks after treatment with inhaled corticosteroids patients will perform the same tests. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bronchial provocation test with mannitol | Procedure | Bronchial provocation test with mannitol: Aridol is supplied in kit form containing sufficient capsules to complete one complete challenge, and the inhalation device.
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| Measure | Description | Time Frame |
|---|---|---|
| The intensity of coughing on a 10-cm visual scale | 6 weeks after treatment with inhaled corticosteroids |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity, specificity, positive predictive value and negative predictive value of the threshold value of 35 ppb FeNo to the clinical response seen as positive if the EVA reduces cough of at least 2 cm | 6 weeks after treatment with inhaled corticosteroids | |
| Sensitivity, specificity, positive predictive value and negative predictive value of response to bronchial provocation test with mannitol on the clinical response seen as positive if the EVA reduces cough of at least 2 cm |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frédéric COSTES, MD PhD | CHU de Saint-Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Saint-Etienne | Saint-Etienne | 42055 | France |
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| 6 weeks after treatment with inhaled corticosteroids |
| Correlation between the value of FeNo and dose of mannitol causing a fall of 15% of maximum volume expired second (PD15) | 6 weeks after treatment with inhaled corticosteroids |
| Score quality of life of the Leicester Cough Questionnaire | 6 weeks after treatment with inhaled corticosteroids |
| ID | Term |
|---|---|
| D003371 | Cough |
| D016535 | Bronchial Hyperreactivity |
| D000096822 | Chronic Cough |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001982 | Bronchial Diseases |
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| ID | Term |
|---|---|
| D008353 | Mannitol |
| ID | Term |
|---|---|
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |
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