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NCT Number: NCT00916526

Measurement of Exhaled Nitric Oxide (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%.

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Key information

Conditions

Cough Bronchial Diseases Bronchial Hyperreactivity Chronic Cough Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Saint-Etienne

Saint-Etienne, 42055, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bronchial provocation test with mannitol

Procedure

Bronchial provocation test with mannitol: Aridol is supplied in kit form containing sufficient capsules to complete one complete challenge, and the inhalation device.

  • Apply nose clip and subject should be directed to breathe through the mouth
  • 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)
  • The patient should exhale completely, before inhaling from device in a controlled rapid deep inspiration
  • 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
  • At the end of 60 seconds, measure the FEV1 in duplicate (this becomes baseline FEV1)
  • Insert 5 mg capsule into inhalation device, and proceed as above
  • 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

Primary outcomes

  1. The intensity of coughing on a 10-cm visual scale

    Time frame: 6 weeks after treatment with inhaled corticosteroids

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. Score quality of life of the Leicester Cough Questionnaire

    Time frame: 6 weeks after treatment with inhaled corticosteroids

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Collaborators

  • Syntara

Registry information

Official study title

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

Acronym: MANOTOUX

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jun 9, 2009
Registry last updated
Nov 24, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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