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Trial record 22 of 857 for:    ALBUTEROL

Aerosolized Albuterol Use in Severe BPD

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ClinicalTrials.gov Identifier: NCT02766673
Recruitment Status : Completed
First Posted : May 10, 2016
Results First Posted : July 30, 2019
Last Update Posted : August 27, 2019
Sponsor:
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Severe Bronchopulmonary Dysplasia
Interventions Drug: Albuterol Sulfate
Drug: Sterile Saline
Enrollment 24
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Treatment Sequence A Treatment Sequence B Treatment Sequence C Treatment Sequence D Treatment Sequence E Treatment Sequence F
Hide Arm/Group Description

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 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 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 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 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 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

Period Title: Overall Study
Started 4 4 4 4 4 4
Completed 3 4 4 4 4 3
Not Completed 1 0 0 0 0 1
Arm/Group Title Overall Study
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 24 participants
170.4  (49.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Female
10
  41.7%
Male
14
  58.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Hispanic or Latino
4
  16.7%
Not Hispanic or Latino
20
  83.3%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
9
  37.5%
White
4
  16.7%
More than one race
0
   0.0%
Unknown or Not Reported
11
  45.8%
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 24 participants
4.7  (1.5)
Birth Gestational Age  
Mean (Standard Deviation)
Unit of measure:  Weeks
Number Analyzed 24 participants
25  (1.9)
Birth Weight  
Median (Standard Deviation)
Unit of measure:  g
Number Analyzed 24 participants
611  (12)
Corrected Gestational Age  
Mean (Standard Deviation)
Unit of measure:  Weeks
Number Analyzed 24 participants
49  (6.5)
1.Primary Outcome
Title Change in Expiratory Flow Between Pre and Post-medication Dosing
Hide Description 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.
Time Frame every 4 hours in each treatment group, up to 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Full Dose Albuterol Sulfate Half Dose Albuterol Sulfate Sterile Saline
Hide Arm/Group Description:

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

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

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

Overall Number of Participants Analyzed 23 23 23
Overall Number of Units Analyzed
Type of Units Analyzed: EF 75% Observatrions
129 141 134
Mean (Standard Deviation)
Unit of Measure: L/min
0.38  (2.3) 0.70  (2.4) 0.45  (2.5)
2.Secondary Outcome
Title Percent Change in Heart Rate (Beats/Min) Between Pre and Post-medication Dosing
Hide Description 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.
Time Frame every 4 hours in each treatment group, up to 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Full Dose Albuterol Sulfate Half Dose Albuterol Sulfate Sterile Saline
Hide Arm/Group Description:

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

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

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

Overall Number of Participants Analyzed 23 23 23
Overall Number of Units Analyzed
Type of Units Analyzed: Heart Rate measurements beats/min
132 144 138
Mean (Standard Deviation)
Unit of Measure: % change
0.074  (0.129) 0.031  (0.120) 0.009  (0.084)
Time Frame Adverse events were continuously monitored for and were attributed to a given treatment group from the time that the first treatment was given through the washout phase following the given treatment group. Albuterol has an effect range for 4-6 hours so any adverse events from the medication. Time frame of monitoring for adverse events ended 6 hours after the final medication dose was administered.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Full Dose Albuterol Half Dose Albuterol Sterile Saline
Hide Arm/Group Description

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

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

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

All-Cause Mortality
Full Dose Albuterol Half Dose Albuterol Sterile Saline
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)   0/23 (0.00%)   0/23 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Full Dose Albuterol Half Dose Albuterol Sterile Saline
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)   0/23 (0.00%)   0/23 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Full Dose Albuterol Half Dose Albuterol Sterile Saline
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)   0/23 (0.00%)   0/23 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Natalie Napolitano, MPH, RRT-NPS, FAARC
Organization: Children's Hospital of Philadelphia
Phone: 215-590-1708
EMail: napolitanon@email.chop.edu
Layout table for additonal information
Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT02766673     History of Changes
Other Study ID Numbers: 15-012264
First Submitted: May 9, 2016
First Posted: May 10, 2016
Results First Submitted: April 22, 2019
Results First Posted: July 30, 2019
Last Update Posted: August 27, 2019