Measurement of Exhaled Nitric Oxide (NO) and Bronchial Provocation Test With Mannitol as a Predictor of Response to Inhaled Corticosteroids in Chronic Cough (MANOTOUX)
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Purpose
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%.
| Condition | Intervention |
|---|---|
|
Cough Bronchial Hyperreactivity |
Procedure: bronchial provocation test with mannitol |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Measurement of Exhaled NO and Bronchial Provocation Test With Mannitol as a Predictor of Response to Inhaled Corticosteroids in Chronic Cough |
- The intensity of coughing on a 10-cm visual scale [ Time Frame: 6 weeks after treatment with inhaled corticosteroids ] [ Designated as safety issue: No ]
- 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 [ Time Frame: 6 weeks after treatment with inhaled corticosteroids ] [ Designated as safety issue: No ]
- 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 [ Time Frame: 6 weeks after treatment with inhaled corticosteroids ] [ Designated as safety issue: No ]
- Correlation between the value of FeNo and dose of mannitol causing a fall of 15% of maximum volume expired second (PD15) [ Time Frame: 6 weeks after treatment with inhaled corticosteroids ] [ Designated as safety issue: No ]
- Score quality of life of the Leicester Cough Questionnaire [ Time Frame: 6 weeks after treatment with inhaled corticosteroids ] [ Designated as safety issue: No ]
| Enrollment: | 30 |
| Study Start Date: | November 2008 |
| Study Completion Date: | September 2010 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: bronchial provocation test with mannitol
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. |
Procedure: bronchial provocation test with mannitol
Bronchial provocation test with mannitol: Aridol is supplied in kit form containing sufficient capsules to complete one complete challenge, and the inhalation device.
Other Name: Aridol
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| France | |
| CHU de Saint-Etienne | |
| Saint-Etienne, France, 42055 | |
| Principal Investigator: | Frédéric COSTES, MD PhD | CHU de Saint-Etienne |
More Information
No publications provided
| Responsible Party: | Clément Caillaux, CHU de Saint-Etienne |
| ClinicalTrials.gov Identifier: | NCT00916526 History of Changes |
| Other Study ID Numbers: | 0808078, 2008-A00846-49 |
| Study First Received: | June 8, 2009 |
| Last Updated: | November 23, 2010 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) France: French Data Protection Authority |
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
|
Chronic cough Inhaled corticosteroid treatment Bronchial provocation test with mannitol Methacholine |
Additional relevant MeSH terms:
|
Cough Bronchial Hyperreactivity Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms Bronchial Diseases Mannitol |
Diuretics, Osmotic Diuretics Natriuretic Agents Physiological Effects of Drugs Pharmacologic Actions Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013