Trial Outcomes & Findings for Aerosolized Albuterol Use in Severe BPD (NCT NCT02766673)

Last Updated: 2019-08-28

Results Overview

Expiratory flow at 75% of vital capacity (EF75) will be measured before beginning each treatment and again 15-30 min after each treatment phase. Therefore there will be 6 pairs (12) of EF values to determine the change in EF for each treatment. this measure is done by measuring the expiratory flow at 75% of exhalation on as measure on the flow volume loop of the ventilator. a single mechanical breath is chosen and the flow volume loop is frozen on the ventilator screen. the clinician can then scroll to measure total tidal volume for the breath, then multiple this volume by 0.25 (to ascertain the volume that the time point of 75% of exhalation), then scroll along the expiratory side of the flow volume loop until the calculated volume is reached and then the flow at that time point is recorded.

Recruitment status

COMPLETED

Study phase

Target enrollment

24 participants

Primary outcome timeframe

every 4 hours in each treatment group, up to 24 hours

Results posted on

2019-08-28

Participant Flow

The original study sample size called for 25 subjects. The block randomization scheme of 6 treatment sequences within 1 randomization block. Therefore we recruited 24 patients to complete 4 randomization block. the 25th patient would have started a new randomization block and make one treatment sequence more common that the others.

Participant milestones

Participant milestones
Measure	Treatment Sequence A Treatment group 1: Placebo (0.9% sterile saline) every 4 hours for 24 hours 6 hour washout phase Treatment group 2: 1.25mg Albuterol every 4 hours for 24 hours 6 hour washout phase Treatment group 3: 2.5 mg Albuterol every 4 hours for 24 hours	Treatment Sequence B Treatment group 1: Placebo (0.9% sterile saline) every 4 hours for 24 hours 6 hour washout phase Treatment group 2: 2.5mg Albuterol every 4 hours for 24 hours 6 hour washout phase Treatment group 3: 1.25mg Albuterol every 4 hours for 24 hours	Treatment Sequence C Treatment Group 1: 1.25 mg Albuterol every 4 hours for 24 hours 6 hour washout phase Treatment group 2: Placebo (0.9% sterile saline) every 4 hours for 24 hours 6 hour washout phase Treatment group 3: 2.5mg albuterol every 4 hours for 24 hours	Treatment Sequence D Treatment Group 1: 1.25 mg Albuterol every 4 hours for 24 hours 6 hour washout phase Treatment group 2: 2.5mg albuterol every 4 hours for 24 hours 6 hour washout phase Treatment group 3: Placebo (0.9% sterile saline) every 4 hours for 24 hours	Treatment Sequence E Treatment group 1: 2.5mg albuterol every 4 hours for 24 hours 6 hour washout phase Treatment group 2: Placebo (0.9% sterile saline) every 4 hours for 24 hours 6 hour washout phase Treatment Group 3: 1.25 mg Albuterol every 4 hours for 24 hours	Treatment Sequence F Treatment group 1: 2.5mg albuterol every 4 hours for 24 hours 6 hour washout phase Treatment Group 2: 1.25 mg Albuterol every 4 hours for 24 hours 6 hour washout phase Treatment group 3: Placebo (0.9% sterile saline) every 4 hours for 24 hours
Overall Study STARTED	4	4	4	4	4	4
Overall Study COMPLETED	3	4	4	4	4	3
Overall Study NOT COMPLETED	1	0	0	0	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Aerosolized Albuterol Use in Severe BPD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Study n=24 Participants This was a crossover study therefore all patients were scheduled to receive all 3 treatment groups. Enrollment demographics will be the same for all groups.
Age, Continuous	170.4 days STANDARD_DEVIATION 49.4 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	11 Participants n=5 Participants
Weight	4.7 kg STANDARD_DEVIATION 1.5 • n=5 Participants
Birth Gestational Age	25 weeks STANDARD_DEVIATION 1.9 • n=5 Participants
Birth Weight	611 g STANDARD_DEVIATION 12 • n=5 Participants
Corrected Gestational Age	49 Weeks STANDARD_DEVIATION 6.5 • n=5 Participants

PRIMARY outcome

Timeframe: every 4 hours in each treatment group, up to 24 hours

Population: Each subject had the potential for 6 paired observations (12 measures) per treatment group (comparison of measure before and after each dose of the study drug). 2 subjects did not complete all 3 treatment groups. Some measurements were missed leaving less than the total potential number of observations.

Outcome measures

Outcome measures
Measure	Full Dose Albuterol Sulfate n=23 Participants 2.5mg of Albuterol Sulfate will be administered via nebulizer and mechanical ventilator Albuterol Sulfate: Subjects will receive a dose of study medication every 4 hours for 24 total hours	Half Dose Albuterol Sulfate n=23 Participants 1.25mg of Albuterol Sulfate will be administered via nebulizer and mechanical ventilator Albuterol Sulfate: Subjects will receive a dose of study medication every 4 hours for 24 total hours	Sterile Saline n=23 Participants 3ml of 0.9% sterile saline will be administered via nebulizer and mechanical ventilator Sterile Saline: Subjects will receive a dose of study medication every 4 hours for 24 total hours
Change in Expiratory Flow Between Pre and Post-medication Dosing	0.38 L/min Standard Deviation 2.3	0.70 L/min Standard Deviation 2.4	0.45 L/min Standard Deviation 2.5

SECONDARY outcome

Timeframe: every 4 hours in each treatment group, up to 24 hours

Population: There was a potential for up to 6 paired observations (12 measures) per treatment group. 2 patients did not complete all 3 treatment groups resulting is lower number of observations for the potential total.

Heart rate will be measured before beginning each treatment and again 15-30 min after the conclusion of each treatment phase (4 hours). Therefore there will be 6 pairs of heart rates (12 measures), to determine the change in HR for each treatment group.

Outcome measures

Outcome measures
Measure	Full Dose Albuterol Sulfate n=132 Heart Rate measurements beats/min 2.5mg of Albuterol Sulfate will be administered via nebulizer and mechanical ventilator Albuterol Sulfate: Subjects will receive a dose of study medication every 4 hours for 24 total hours	Half Dose Albuterol Sulfate n=144 Heart Rate measurements beats/min 1.25mg of Albuterol Sulfate will be administered via nebulizer and mechanical ventilator Albuterol Sulfate: Subjects will receive a dose of study medication every 4 hours for 24 total hours	Sterile Saline n=23 Participants 3ml of 0.9% sterile saline will be administered via nebulizer and mechanical ventilator Sterile Saline: Subjects will receive a dose of study medication every 4 hours for 24 total hours
Percent Change in Heart Rate (Beats/Min) Between Pre and Post-medication Dosing	0.074 % change Standard Deviation 0.129	0.031 % change Standard Deviation 0.120	0.009 % change Standard Deviation 0.084

Adverse Events

Full Dose Albuterol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Half Dose Albuterol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sterile Saline

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

Natalie Napolitano, MPH, RRT-NPS, FAARC

Children's Hospital of Philadelphia

Phone: 215-590-1708

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place