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

NCT00916526 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2010-11-24

No results posted yet for this study

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%.

Conditions

  • Cough
  • Bronchial Hyperreactivity

Interventions

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.

Sponsors & Collaborators

  • Syntara

    collaborator INDUSTRY

  • Centre Hospitalier Universitaire de Saint Etienne

    lead OTHER

Principal Investigators

  • Frédéric COSTES, MD PhD · CHU de Saint-Etienne

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00916526 on ClinicalTrials.gov