Airway Inflammation in Congenital Diaphragmatic Hernia Patients

NCT02453750 | Completed Results

• 1 other identifier: 1000028032
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Diaphragmatic Hernia

Keywords

Congenital Diaphragmatic Hernia; Airway Inflammation; Asthma; Hypersaline; Pediatrics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Number of Participant With Elevated Sputum Neutrophils

  Baseline, +30 minutes

• Number of Participant With Elevated Exhaled Nitric Oxide (NO) Level

  30 min

• Number of Participant With Bronchodilator Response

  life time of child (age 6 to present age)

Study Arms (1)

Hypersaline and Bronchodilator Response

EXPERIMENTAL

After the subject has performed post-bronchodilator spirometry, they will inhale 5 mls of 3% hypertonic saline for 7 minutes by nebulizer.

Drug: Hypersaline; Drug: Bronchodilator Response

Interventions

Hypersaline DRUG

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.

Hypersaline and Bronchodilator Response

Bronchodilator Response DRUG

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.

Hypersaline and Bronchodilator Response

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Hernias, Diaphragmatic, Congenital; Asthma

Condition Hierarchy (Ancestors)

Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Diaphragmatic; Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Dr Theo Moraes
• Organization: SickKids

theo.moraes@sickkids.ca

416 813 2196

Study Officials

• Theo Moraes, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Respirologist

Study Record Dates

• First Submitted: May 21, 2015
• First Posted: May 25, 2015
• Study Start: February 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: January 31, 2019
• Results First Posted: January 31, 2019

Record last verified: 2018-08

Locations

CA (1)