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

Cough Clinical Trial

— MANOTOUX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00916526
• Other study ID #: 0808078
• Secondary ID: 2008-A00846-49
• Status: Completed
• Phase: N/A
• First received: June 8, 2009
• Last updated: November 23, 2010
• Start date: November 2008
• Est. completion date: September 2010

Study information

• Verified date: November 2010
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: French Data Protection Authority
• Study type: Interventional

Clinical Trial 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%.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Bronchial Hyperreactivity
• Cough

Intervention

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. 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.

Locations

Country	Name	City	State
France	CHU de Saint-Etienne	Saint-Etienne

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Pharmaxis

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The intensity of coughing on a 10-cm visual scale		6 weeks after treatment with inhaled corticosteroids	No
Secondary	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		6 weeks after treatment with inhaled corticosteroids	No
Secondary	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		6 weeks after treatment with inhaled corticosteroids	No
Secondary	Correlation between the value of FeNo and dose of mannitol causing a fall of 15% of maximum volume expired second (PD15)		6 weeks after treatment with inhaled corticosteroids	No
Secondary	Score quality of life of the Leicester Cough Questionnaire		6 weeks after treatment with inhaled corticosteroids	No