Airway Inflammation in Congenital Diaphragmatic Hernia Patients

Congenital Diaphragmatic Hernia Clinical Trial

Official title:

Investigation of Airway Inflammation in Congenital Diaphragmatic Hernia Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02453750
• Other study ID #: 1000028032
• Status: Completed
• Phase: N/A
• Start date: February 2012
• Est. completion date: October 2013

Study information

• Verified date: August 2018
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Congenital Diaphragmatic Hernia
• Hernia
• Hernia, Diaphragmatic
• Hernias, Diaphragmatic, Congenital
• Inflammation

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Elevated Sputum Eosinophils	Number of participants with sputum eosinophils greater than 3% percent of cells in the sputum	post sputum induction
Secondary	Number of Participant With Elevated Sputum Neutrophils	Elevation is defined as sputum neutrophils > or = 61% neutrophils = neutrophilic inflammation	Baseline, +30 minutes
Secondary	Number of Participant With Elevated Exhaled Nitric Oxide (NO) Level	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	30 min
Secondary	Number of Participant With Bronchodilator Response	defined as a = or > 12% change in FEV1 post bronchodilator	life time of child (age 6 to present age)