Airway Inflammation in Congenital Diaphragmatic Hernia Patients

• 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: The Hospital for Sick Children
• Information provided by (Responsible Party): Theo Moraes, The Hospital for Sick Children

Study Description

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

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

Canada, Ontario

The Hospital for Sick Children

Toronto, Ontario, Canada, M5G 1X8

Sponsors and Collaborators

The Hospital for Sick Children

Investigators

• Principal Investigator: Theo Moraes, MD; The Hospital for Sick Children

More Information

• 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
• 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:

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