- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02586883
Bronchial Trans-epithelial Transport in Patients With Idiopathic Multiple Dilations of the Bronchi (EPITRANS)
Study of the Bronchial Trans-epithelial Transport in Patients With Idiopathic Multiple Dilations of the Bronchi
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Dilations of the bronchi happens for one child over 3000. The extended forms may progress to respiratory failure. More than one case over two remains of undetermined cause. If the prototype is the cystic fibrosis, other abnormalities of ionic transport may be the cause of a failure of mucociliary clearance and enhance the idiopathic dilations of the bronchi.
The purpose of this study is to identify the abnormalities of bronchial trans-epithelial transport of chloride, sodium and bicarbonate in patients with idiopathic dilations of the bronchi, in comparison to two others groups of patients (without abnormality of ionic transport/with typical cystic fibrosis).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Paris, France, 75015
- Necker-Enfants Malades Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Common criteria for all patients
- Age between 2 and 20 years.
- Patient weighing more than 12kg
- Patients with a scheduled bronchoscopy under clinical monitoring (assessment of bronchial involvement, local samples for bacteriological and histological examination)
- Signature of consent by the patient or by the / the holder (s) of parental authority and the investigator
- Patient affiliated to a social security scheme or entitled
- Patient with contraception (for woman of childbearing age) Specific criteria for idiopathic bronchiectasis patients Patient with idiopathic bronchiectasis in at least two lobes, diagnosis made after extensive screening of known acquired or congenital causes
Specific criteria for "control" patients without abnormal ion transport
- Patient Not having bronchiectasis s or any supposed alteration in transepithelial ion transport
- Patients with fiberoptic bronchoscopy performed for one of the following indications:
- Pulmonary malformations
- Laryngeal, tracheal, bronchomalacia
- Airway compression
- Interstitial pathology
- Suspicion of foreign body
- Suspected tuberculosis Specific criteria for patients with a typical form of cystic f ibrosis (CF) Patient carrying 2 causing mutations in the CFTR gene (according to CFTR2 database; http://www.cftr2.org/mutations_history.php) and sweat test> 60 milliequivalent per liter (mEq/L).
Exclusion Criteria:
Common criteria for all patients
- Smoking passive or active
- Not essential bronchial endoscopy in the clinical follow
- Extension of bronchoscopy time attributed to the difference in potential bronchial incompatible with the patient's general status
- Patient pregnant or breast feeding
- Hypersensitivity or cons known contraindications to health products for measurement of DDP (isoproterenol, Amiloride, ATP)
Specific criteria for idiopathic DDB patients
Presence of other congenital or acquired etiologies of DDB:
- Typical or atypical cystic fibrosis,
- Immunodeficiency,
- Primary ciliary dyskinesia,
- Abnormal bronchial wall structure (Williams-Campbell syndrome, Mounier-Kuhn, Ehlers-Danlos syndrome, Marfan's disease)
- Infectious DDBs post
- Extrinsic or endobronchial obstruction (foreign body, malformation, middle lobe syndrome)
- Chronic inhalation (GERD, swallowing disorders, gastroesophageal tracheal fistula)
- Allergic bronchopulmonary aspergillosis,
- System disease.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Patients with multiple bronchi dilations
|
bronchial ddp test during endoscopy, nasal smear, bronchial smear
|
Active Comparator: Control patients without transport abnormality
|
bronchial ddp test during endoscopy, nasal smear, bronchial smear
|
Active Comparator: Patients with typical cystic fibrosis
|
bronchial ddp test during endoscopy, nasal smear, bronchial smear
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response to isoproterenol in solution without chloride ions during bronchial potential difference test (ΔIsoprotérénol / bronchial).
Time Frame: up to 5 days
|
Difference between groups for Level of repolarisation
|
up to 5 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response to amiloride during bronchial potential difference test
Time Frame: up to 5 days
|
Trans-epithelial transport measured in vivo
|
up to 5 days
|
trans-epithelial ionic transport in the nasal epithelium (nasal DDP)
Time Frame: up to 5 days
|
Trans-epithelial transport measured in vivo
|
up to 5 days
|
trans-epithelial ionic transport of sweat epithelium (sweat test)
Time Frame: up to 5 days
|
Trans-epithelial transport measured in vivo
|
up to 5 days
|
Basal current short circuit
Time Frame: up to 5 days
|
Trans-bronchial epithelial ionic transport evaluated in vitro on bronchial primary cultures
|
up to 5 days
|
Response to Epithelial Sodium Channel (ENaC) inhibitors
Time Frame: up to 5 days
|
Trans-bronchial epithelial ionic transport evaluated in vitro on bronchial primary cultures
|
up to 5 days
|
Activation of Cystic Fibrosis Transmembrane Conductance Regulator (CFTR)
Time Frame: up to 5 days
|
Trans-bronchial epithelial ionic transport evaluated in vitro on bronchial primary cultures
|
up to 5 days
|
Inhibition of Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) (inh-172)
Time Frame: up to 5 days
|
Trans-bronchial epithelial ionic transport evaluated in vitro on bronchial primary cultures
|
up to 5 days
|
Activation of Calcium (Ca)-dependent Chloride (Cl-) ion channels
Time Frame: up to 5 days
|
Trans-bronchial epithelial ionic transport evaluated in vitro on bronchial primary cultures
|
up to 5 days
|
Inhibition of Solute Carrier family 26, member 9 (SLC26A9)
Time Frame: up to 5 days
|
Trans-bronchial epithelial ionic transport evaluated in vitro on bronchial primary cultures
|
up to 5 days
|
Response to inhibitors of potassium (K+ ) secretion basolateral
Time Frame: up to 5 days
|
Trans-bronchial epithelial ionic transport evaluated in vitro on bronchial primary cultures
|
up to 5 days
|
Bicarbonate (HCO3- ) secretion in response to forskolin
Time Frame: up to 5 days
|
Trans-bronchial epithelial ionic transport evaluated in vitro on bronchial primary cultures
|
up to 5 days
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-A00731-48
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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