Measurement of Exhaled Nitric Oxide (NO) and Bronchial Provocation Test With Mannitol as a Predictor of Response to Inhaled Corticosteroids in Chronic Cough (MANOTOUX)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00916526|
Recruitment Status : Completed
First Posted : June 9, 2009
Last Update Posted : November 24, 2010
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 or disease||Intervention/treatment||Phase|
|Cough Bronchial Hyperreactivity||Procedure: bronchial provocation test with mannitol||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Measurement of Exhaled NO and Bronchial Provocation Test With Mannitol as a Predictor of Response to Inhaled Corticosteroids in Chronic Cough|
|Study Start Date :||November 2008|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||September 2010|
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
- The intensity of coughing on a 10-cm visual scale [ Time Frame: 6 weeks after treatment with inhaled corticosteroids ]
- 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 ]
- 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 ]
- 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 ]
- Score quality of life of the Leicester Cough Questionnaire [ Time Frame: 6 weeks after treatment with inhaled corticosteroids ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00916526
|CHU de Saint-Etienne|
|Saint-Etienne, France, 42055|
|Principal Investigator:||Frédéric COSTES, MD PhD||CHU de Saint-Etienne|