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Airway Inflammation in Congenital Diaphragmatic Hernia Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02453750
Recruitment Status : Completed
First Posted : May 25, 2015
Results First Posted : January 31, 2019
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
Theo Moraes, The Hospital for Sick Children

Brief Summary:
We propose to examine Congenital Diaphragmatic Hernia (CDH) patients for evidence of airway inflammation as a first step to characterize the reported bronchodilator responsiveness. Airway biopsy studies are invasive and thus we propose to perform induced sputum studies to document the amount and type of inflammation present. Another ancillary non-invasive measure of airway inflammation that we will use is exhaled nitric oxide (NO). The primary objective of this study is to determine if CDH patients have any evidence of airway inflammation. The hypothesis of this study is that children with CDH do not have evidence of airway inflammation associated with bronchodilator responsiveness. Based on this information, treatment for CDH patients will hopefully be more accurate and appropriate for their specific needs.

Condition or disease Intervention/treatment Phase
Congenital Diaphragmatic Hernia Drug: Hypersaline Drug: Bronchodilator Response Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Investigation of Airway Inflammation in Congenital Diaphragmatic Hernia Patients
Study Start Date : February 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
Experimental: Hypersaline and Bronchodilator Response
After the subject has performed post-bronchodilator spirometry, they will inhale 5 mls of 3% hypertonic saline for 7 minutes by nebulizer.
Drug: Hypersaline
Subject will inhale 5 mls of 3% hypertonic saline for 7 minutes by nebulizer. Sputum production (with cough) will be attempted post inhalation. A maximum of 3 hypertonic saline inhalations will be attempted if inhalation does not generate a productive cough. If sputum induction is not successful and the FEV1 falls <10%, the concentration of inhaled hypertonic saline will increase from 3 to 4%. If 5 mls of 4% hypertonic saline inhaled for 7 minutes does not produce a productive cough we will proceed to 5%. If 5 mls of 5% hypertonic saline inhaled for 7 minutes does not produce a productive cough the test is complete and the sample is labelled 'no sputum collected'. If FEV1 falls >10%, the previous step will be repeated.

Drug: Bronchodilator Response
A bronchodilator (Salbutamol 200 mcg or 2 puffs inhaled via spacer device) will be administered to all subjects in the pulmonary function laboratory. 15 minutes after administration of the bronchodilator spirometry will be repeated. This is performed routinely in CDH clinic and is not an additional test for this study.




Primary Outcome Measures :
  1. Number of Participants With Elevated Sputum Eosinophils [ Time Frame: post sputum induction ]
    Number of participants with sputum eosinophils greater than 3% percent of cells in the sputum


Secondary Outcome Measures :
  1. Number of Participant With Elevated Sputum Neutrophils [ Time Frame: Baseline, +30 minutes ]
    Elevation is defined as sputum neutrophils > or = 61% neutrophils = neutrophilic inflammation

  2. Number of Participant With Elevated Exhaled Nitric Oxide (NO) Level [ Time Frame: 30 min ]

    exhaled NO measurements will be performed according to the American Thoracic Society and European Respiratory Society guidelines. These tests are performed routinely as part of the respiratory evaluation of these patients and are not additional tests added for this study.

    greater than 20 ppb was considered elevated


  3. Number of Participant With Bronchodilator Response [ Time Frame: life time of child (age 6 to present age) ]
    defined as a = or > 12% change in FEV1 post bronchodilator



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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 6 - 18 years of age at enrolment
  • Clinically stable at enrolment
  • Attending follow-up in the CDH Clinic at SickKids

Exclusion Criteria:

  • Unable to perform pulmonary function testing
  • Clinically unstable at enrolment
  • Known hypersensitivity to salbutamol

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): NCT02453750


Locations
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Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
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Principal Investigator: Theo Moraes, MD The Hospital for Sick Children
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Responsible Party: Theo Moraes, Staff Respirologist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT02453750    
Other Study ID Numbers: 1000028032
First Posted: May 25, 2015    Key Record Dates
Results First Posted: January 31, 2019
Last Update Posted: January 31, 2019
Last Verified: August 2018
Keywords provided by Theo Moraes, The Hospital for Sick Children:
Congenital Diaphragmatic Hernia
Airway Inflammation
Asthma
Hypersaline
Pediatrics
Additional relevant MeSH terms:
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Hernias, Diaphragmatic, Congenital
Inflammation
Hernia
Hernia, Diaphragmatic
Pathologic Processes
Pathological Conditions, Anatomical
Internal Hernia
Congenital Abnormalities
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents