Cough Clinical Trial
— MANOTOUXOfficial title:
Measurement of Exhaled NO and Bronchial Provocation Test With Mannitol as a Predictor of Response to Inhaled Corticosteroids in Chronic Cough
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%.
Status | Completed |
Enrollment | 30 |
Est. completion date | September 2010 |
Est. primary completion date | September 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Chronic Cough during 2 months - Social Security regimen affiliated - Consent form signed Exclusion Criteria: - Smoking active - Treatment with angiotensin converting enzyme inhibitor - Clinical signs of obvious gastroesophageal reflux - Clinical rhinosinusitis - Recent respiratory infection (< 1 month) - Corticosteroid Treatment(oral or inhaled) within 2 weeks - VEMS < 1 L or < 80% of the theoretical value - Existence of an obstructive ventilatory disorder defined as a report (FEV/FVC) < 90% of the theoretical value |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
France | CHU de Saint-Etienne | Saint-Etienne |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Saint Etienne | Pharmaxis |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The intensity of coughing on a 10-cm visual scale | 6 weeks after treatment with inhaled corticosteroids | No | |
Secondary | 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 | No | |
Secondary | 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 | 6 weeks after treatment with inhaled corticosteroids | No | |
Secondary | 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 | No | |
Secondary | Score quality of life of the Leicester Cough Questionnaire | 6 weeks after treatment with inhaled corticosteroids | No |
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