N/A
N=21
Airway Inflammation in Congenital Diaphragmatic Hernia Patients
Congenital Diaphragmatic Hernia
Bottom Line
View on ClinicalTrials.gov: NCT02453750 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcome: Primary: Number of Participants With Elevated Sputum Eosinophils — 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Hypersaline (Drug); Bronchodilator Response (Drug)
- Age
- Pediatric, Adult · 6+ yrs
- Sex
- All
- Sponsor
- The Hospital for Sick Children
- Primary completion
- Oct 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Elevated Sputum Eosinophils |
— | — |
| SECONDARY Number of Participant With Elevated Sputum Neutrophils |
— | — |
| SECONDARY Number of Participant With Elevated Exhaled Nitric Oxide (NO) Level |
2 | — |
| SECONDARY Number of Participant With Bronchodilator Response |
15 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02453750). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.