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Trial record 1 of 1 for:    NCT02586883
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Bronchial Trans-epithelial Transport in Patients With Idiopathic Multiple Dilations of the Bronchi (EPITRANS)

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ClinicalTrials.gov Identifier: NCT02586883
Recruitment Status : Recruiting
First Posted : October 27, 2015
Last Update Posted : April 30, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Idiopathic Dilation of the Bronchi Other: bronchial ddp test Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Study of the Bronchial Trans-epithelial Transport in Patients With Idiopathic Multiple Dilations of the Bronchi
Actual Study Start Date : March 29, 2016
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : April 2020

Arm Intervention/treatment
Experimental: Patients with multiple bronchi dilations Other: bronchial ddp test
bronchial ddp test during endoscopy, nasal smear, bronchial smear

Active Comparator: Control patients without transport abnormality Other: bronchial ddp test
bronchial ddp test during endoscopy, nasal smear, bronchial smear

Active Comparator: Patients with typical cystic fibrosis Other: bronchial ddp test
bronchial ddp test during endoscopy, nasal smear, bronchial smear




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Response to amiloride during bronchial potential difference test [ Time Frame: up to 5 days ]
    Trans-epithelial transport measured in vivo

  2. trans-epithelial ionic transport in the nasal epithelium (nasal DDP) [ Time Frame: up to 5 days ]
    Trans-epithelial transport measured in vivo

  3. trans-epithelial ionic transport of sweat epithelium (sweat test) [ Time Frame: up to 5 days ]
    Trans-epithelial transport measured in vivo

  4. Basal current short circuit [ Time Frame: up to 5 days ]
    Trans-bronchial epithelial ionic transport evaluated in vitro on bronchial primary cultures

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02586883


Contacts
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Contact: Isabelle SERMET-GAUDELUS, MD, PhD +33144494887 isabelle.sermet@nck.aphp.fr
Contact: sophie LE GUEN, Master +33144494327 sophie.le-guen@nck.aphp.fr

Locations
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France
Necker-Enfants Malades Hospital Recruiting
Paris, France, 75015
Contact: Isabelle SERMET-GAUDELUS, MD, PhD    +33144494887    isabelle.sermet@nck.aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02586883    
Other Study ID Numbers: 2015-A00731-48
First Posted: October 27, 2015    Key Record Dates
Last Update Posted: April 30, 2018
Last Verified: April 2018
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Dilation of the Bronchi
Bronchial potential difference
Dilation of the Bronchi (DDB)
Additional relevant MeSH terms:
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Dilatation, Pathologic
Pathological Conditions, Anatomical