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

November 23, 2010 updated by: Centre Hospitalier Universitaire de Saint Etienne

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

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%.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Saint-Etienne, France, 42055
        • CHU de Saint-Etienne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

  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.
Other Names:
  • Aridol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The intensity of coughing on a 10-cm visual scale
Time Frame: 6 weeks after treatment with inhaled corticosteroids
6 weeks after treatment with inhaled corticosteroids

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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
6 weeks after treatment with inhaled corticosteroids

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Collaborators

Pharmaxis

Investigators

  • Principal Investigator: Frédéric COSTES, MD PhD, CHU de Saint-Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

June 8, 2009

First Submitted That Met QC Criteria

June 8, 2009

First Posted (Estimate)

June 9, 2009

Study Record Updates

Last Update Posted (Estimate)

November 24, 2010

Last Update Submitted That Met QC Criteria

November 23, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0808078
  • 2008-A00846-49 (Other Identifier: AFSSAPS)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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