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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 (MANOTOUX)

C

Centre Hospitalier Universitaire de Saint Etienne

Status

Completed

Conditions

Bronchial Hyperreactivity
Cough

Treatments

Procedure: bronchial provocation test with mannitol

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00916526
2008-A00846-49 (Other Identifier)
0808078

Details and patient eligibility

About

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%.

Full 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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

bronchial provocation test with mannitol
Experimental group
Description:
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.
Treatment:
Procedure: bronchial provocation test with mannitol

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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