NCT00916526

Measurement of Exhaled Nitric Oxide (NO) and Bronchial Provocation Test With Mannitol as a Predictor of Response to Inhaled Corticosteroids in Chronic Cough

Measurement of Exhaled NO and Bronchial Provocation Test With Mannitol as a Predictor of Response to Inhaled Corticosteroids in Chronic Cough

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Centre Hospitalier Universitaire de Saint Etienne · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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%.

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.

Conditions

• Cough
• Bronchial Hyperreactivity

Interventions

Type	Name	Description
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. 1. Apply nose clip and subject should be directed to breathe through the mouth 2. Insert 0 mg capsule into inhalation device. Puncture capsule by depressing buttons on side of device slowly, and once only (a second puncture may fragment the capsules) 3. The patient should exhale completely, before inhaling from device in a controlled rapid deep inspiration 4. At the end of deep inspiration, start 60 second timer, subject should hold breath for 5 seconds and exhale through mouth before removal of nose clip 5. At the end of 60 seconds, measure the FEV1 in duplicate (this becomes baseline FEV1) 6. Insert 5 mg capsule into inhalation device, and proceed as above 7. Repeat steps 1 - 4 following the dose steps in the table below until the patient has a positive response or 635 mg has been administered.

Timeline

• Start date: 2008-11-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2009-06-09
• Last updated: 2010-11-24

Locations

1 site across 1 country: France