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

NCT ID: NCT00916526

Last Updated: 2010-11-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2010-09-30

Brief 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%.

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.

Conditions

Cough; Bronchial Hyperreactivity

Keywords

Chronic cough; Inhaled corticosteroid treatment; Bronchial provocation test with mannitol; Methacholine

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

bronchial provocation test with mannitol

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

Aridol

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Syntara

INDUSTRY

Sponsor Role: collaborator

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

CHU de Saint-Etienne

Principal Investigators

Frédéric COSTES, MD PhD

Role: PRINCIPAL_INVESTIGATOR

CHU de Saint-Etienne

Locations

CHU de Saint-Etienne

Saint-Etienne, , France

Countries

France

Other Identifiers

2008-A00846-49

Identifier Type: OTHER

Identifier Source: secondary_id

0808078

Identifier Type: -

Identifier Source: org_study_id