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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)

This study has been completed.
Sponsor:
Collaborator:
Pharmaxis
Information provided by:
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT00916526
First received: June 8, 2009
Last updated: November 23, 2010
Last verified: November 2010
  Purpose

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%.


Condition Intervention
Cough
Bronchial Hyperreactivity
Procedure: bronchial provocation test with mannitol

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Measurement of Exhaled NO and Bronchial Provocation Test With Mannitol as a Predictor of Response to Inhaled Corticosteroids in Chronic Cough

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Saint Etienne:

Primary Outcome Measures:
  • The intensity of coughing on a 10-cm visual scale [ Time Frame: 6 weeks after treatment with inhaled corticosteroids ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Score quality of life of the Leicester Cough Questionnaire [ Time Frame: 6 weeks after treatment with inhaled corticosteroids ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: November 2008
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Aridol

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00916526

Locations
France
CHU de Saint-Etienne
Saint-Etienne, France, 42055
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Pharmaxis
Investigators
Principal Investigator: Frédéric COSTES, MD PhD CHU de Saint-Etienne
  More Information

No publications provided

Responsible Party: Clément Caillaux, CHU de Saint-Etienne
ClinicalTrials.gov Identifier: NCT00916526     History of Changes
Other Study ID Numbers: 0808078, 2008-A00846-49
Study First Received: June 8, 2009
Last Updated: November 23, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: French Data Protection Authority

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Chronic cough
Inhaled corticosteroid treatment
Bronchial provocation test with mannitol
Methacholine

Additional relevant MeSH terms:
Bronchial Hyperreactivity
Cough
Bronchial Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Mannitol
Cardiovascular Agents
Diuretics
Diuretics, Osmotic
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014