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Completed

NCT Number: NCT02453750

Airway Inflammation in Congenital Diaphragmatic Hernia Patients

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.

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Key information

Conditions

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

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

Investigation of Airway Inflammation in Congenital Diaphragmatic Hernia Patients

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 25, 2015
Registry last updated
Jan 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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