CoughMANOTOUXNCT00916526
Measurement of Exhaled Nitric Oxide (NO) and Bronchial Provocation Test With Mannitol as a Predictor of Response to Inhaled Corticosteroids in Chronic Cough
A study testing bronchial provocation test with mannitol in people with Cough and Bronchial Hyperreactivity, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cough, Bronchial Hyperreactivity
- What is being tested?
- bronchial provocation test with mannitol
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2008to Sep 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic Cough during 2 months
- Social Security regimen affiliated
- Consent form signed
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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%.
Read the 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
- Being tested
- bronchial provocation test with mannitol
- Keywords
- Chronic cough, Inhaled corticosteroid treatment, Bronchial provocation test with mannitol, Methacholine
- Medical subject headings
- Cough, Bronchial Hyperreactivity, Chronic Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bronchial provocation test with mannitolProcedure or surgery
Also called Aridol
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.
| Study group | Role | What they receive |
|---|---|---|
| bronchial provocation test with mannitol | Experimental | 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. Receives: Procedure: bronchial provocation test with mannitol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The intensity of coughing on a 10-cm visual scale
Measured: 6 weeks after treatment with inhaled corticosteroids
Secondary outcomes (4)
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
Measured: 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
Measured: 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)
Measured: 6 weeks after treatment with inhaled corticosteroids
Score quality of life of the Leicester Cough Questionnaire
Measured: 6 weeks after treatment with inhaled corticosteroids
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2009 (estimated)
- Study startNov 2008
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoughStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Syntara
- Investigators
- Frédéric COSTES, MD PhD, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00916526
- Sponsor's protocol ID
- 0808078
- Other IDs
- 2008-A00846-49
- Acronym
- MANOTOUX
- Status last verified
- Nov 2010
- First submitted
- 8 Jun 2009
- Last updated
- 24 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Exhaled NO and Bronchial Provocation Test With Mannitol as a Predictor of Response to Inhaled Corticosteroids in Chronic Cough
- ClinicalTrials.gov ID
- NCT00916526
- Acronym / sponsor ID
- MANOTOUX / 0808078
- Conditions
- Cough, Bronchial Hyperreactivity
- Keywords
- Chronic cough, Inhaled corticosteroid treatment, Bronchial provocation test with mannitol, Methacholine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Syntara
- Study start
- Nov 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 9 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| bronchial provocation test with mannitol | Experimental | Procedure: bronchial provocation test with mannitolPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic Cough during 2 months
- Social Security regimen affiliated
- Consent form signed
Key exclusion criteria (8 listed)
- Smoking active
- Treatment with angiotensin converting enzyme inhibitor
- Clinical signs of obvious gastroesophageal reflux
- Clinical rhinosinusitis
- Recent respiratory infection (< 1 month)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bronchial provocation test with mannitolAlso: AridolBronchial 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. | Procedure or surgery | bronchial provocation test with mannitol |
Primary outcome
The intensity of coughing on a 10-cm visual scale
Time frame: 6 weeks after treatment with inhaled corticosteroids
4 secondary outcomes
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
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
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
Score quality of life of the Leicester Cough Questionnaire
Time frame: 6 weeks after treatment with inhaled corticosteroids
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frédéric COSTES, MD PhD principal investigator
CHU de Saint-Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bronchial provocation test with mannitol in people with Cough and Bronchial Hyperreactivity, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The intensity of coughing on a 10-cm visual scale (time frame: 6 weeks after treatment with inhaled corticosteroids). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2010.