Trial Outcomes & Findings for Airway Inflammation in Congenital Diaphragmatic Hernia Patients (NCT NCT02453750)

NCT ID: NCT02453750

Last Updated: 2019-01-31

Results Overview

Number of participants with sputum eosinophils greater than 3% percent of cells in the sputum

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 21 participants
• Primary outcome timeframe: post sputum induction
• Results posted on: 2019-01-31

Participant Flow

Participant milestones

Measure	Hypersaline and Bronchodilator Response Each child will perform a sputum induction to obtain cells for analysis.
Overall Study STARTED	21
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Hypersaline and Bronchodilator Response n=21 Participants After the subject has performed post-bronchodilator spirometry, they will inhale 5 mls of 3% hypertonic saline for 7 minutes by nebulizer to obtain cells for analysis.
Age, Categorical <=18 years	21 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=21 Participants
Sex: Female, Male Female	7 Participants n=21 Participants
Sex: Female, Male Male	14 Participants n=21 Participants

PRIMARY outcome

Timeframe: post sputum induction

Population: 15 gave reasonable sputum for analysis, none had elevated sputum eosinophils

Number of participants with sputum eosinophils greater than 3% percent of cells in the sputum

Outcome measures

Measure	Hypersaline and Bronchodilator Response n=15 Participants everyone performs sputum induction
Number of Participants With Elevated Sputum Eosinophils	0 participants

SECONDARY outcome

Timeframe: Baseline, +30 minutes

Population: 15 gave reasonable sputum

Elevation is defined as sputum neutrophils > or = 61% neutrophils = neutrophilic inflammation

Outcome measures

Measure	Hypersaline and Bronchodilator Response n=15 Participants everyone performs sputum induction
Number of Participant With Elevated Sputum Neutrophils	0 participants

SECONDARY outcome

Timeframe: 30 min

Population: only 12 performed eNO

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

Outcome measures

Measure	Hypersaline and Bronchodilator Response n=12 Participants everyone performs sputum induction
Number of Participant With Elevated Exhaled Nitric Oxide (NO) Level	2 Participants

SECONDARY outcome

Timeframe: life time of child (age 6 to present age)

Population: all subjects performed PFTs

defined as a = or > 12% change in FEV1 post bronchodilator

Outcome measures

Measure	Hypersaline and Bronchodilator Response n=21 Participants everyone performs sputum induction
Number of Participant With Bronchodilator Response	15 participants

Adverse Events

Hypersaline and Bronchodilator Response

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Theo Moraes

SickKids

Phone: 416 813 2196

Email: theo.moraes@sickkids.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place