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Trial record 3 of 857 for:    ALBUTEROL

Preterm Infant Inhaled Albuterol Dosing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02447250
Recruitment Status : Completed
First Posted : May 18, 2015
Results First Posted : May 23, 2019
Last Update Posted : May 23, 2019
Sponsor:
Information provided by (Responsible Party):
Cynthia McEvoy, Oregon Health and Science University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Bronchopulmonary Dysplasia
Very Low Birth Weight
Intervention Drug: Varied albuterol dose response
Enrollment 14
Recruitment Details  
Pre-assignment Details 1 subject was consented into the study, but then became too clinically unstable to participate in the study and remained unstable throughout the eligibility period.
Arm/Group Title Single Arm: Varied Albuterol Dose Response
Hide Arm/Group Description

Subjects will be evaluated in three sessions within a 7 day time span, beginning after 14 days of age and at 28w0d to 33w6d corrected gestational age. In each session, pulmonary function tests (PFTs) will be performed prior to and 15 minutes after a dose of albuterol. The dose will be different in each session. In the first session, a single dose of 180 micrograms (2 puffs) of albuterol sulfate via metered dose inhaler. The dose will be 270 micrograms in the second session and 360 micrograms in the third session. PFTs will be performed during quiet sleep while the baby is spontaneously breathing or while the baby is intubated and receiving mechanical ventilation. Resistance and compliance will be measured using the single breath occlusion technique.

Varied albuterol dose response: Subjects will be evaluated in three sessions. The sessions will occur within a 7 day time span, beginning between 14 or more days from birth and at a corrected gestational age of 2

Period Title: First Dose (180 mcg Albuterol)
Started 14
Completed 14
Not Completed 0
Period Title: Second Dose (270 mcg Albuterol)
Started 14
Completed 13
Not Completed 1
Reason Not Completed
elevated HR with first dose             1
Period Title: Third Dose (360 mcg Albuterol)
Started 13
Completed 8
Not Completed 5
Reason Not Completed
Clinically unstable, unable to do PFT             1
Elevated HR with 2nd dose             4
Arm/Group Title Single Arm: Varied Albuterol Dose Response
Hide Arm/Group Description

Subjects will be evaluated in three sessions within a 7 day time span, beginning after 14 days of age and at 28w0d to 33w6d corrected gestational age. In each session, pulmonary function tests (PFTs) will be performed prior to and 15 minutes after a dose of albuterol. The dose will be different in each session. In the first session, a single dose of 180 micrograms (2 puffs) of albuterol sulfate via metered dose inhaler. The dose will be 270 micrograms in the second session and 360 micrograms in the third session. PFTs will be performed during quiet sleep while the baby is spontaneously breathing or while the baby is intubated and receiving mechanical ventilation. Resistance and compliance will be measured using the single breath occlusion technique.

Varied albuterol dose response: Subjects will be evaluated in three sessions. The sessions will occur within a 7 day time span, beginning between 14 or more days from birth and at a corrected gestational age of 2

Overall Number of Baseline Participants 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Days
Number Analyzed 14 participants
36
(17 to 66)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Female
10
  71.4%
Male
4
  28.6%
birthweight  
Mean (Full Range)
Unit of measure:  Grams
Number Analyzed 14 participants
895
(350 to 1293)
gestational age at birth  
Mean (Full Range)
Unit of measure:  Weeks
Number Analyzed 14 participants
26.9
(24.1 to 29.9)
respiratory support at study entry, CPAP  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
12
  85.7%
respiratory support at study entry, mechanical ventilation  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
2
  14.3%
history of any mechanical ventilation  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
8
  57.1%
received surfactant  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
7
  50.0%
received antenatal corticosteroids  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
13
  92.9%
ever received albuterol prior to study entry  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
0
   0.0%
received diuretics prior to study entry  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
3
  21.4%
reason for preterm delivery: preterm labor  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
6
  42.9%
maternal age, years (mean)  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 14 participants
26.4
(17 to 36)
maternal BMI (mean, range)  
Median (Full Range)
Unit of measure:  Kg/ m^2
Number Analyzed 14 participants
25.5
(18.7 to 47)
maternal diabetes mellitus (pregestational or gestational)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
4
  28.6%
family history of asthma  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
2
  14.3%
maternal smoking during pregnancy  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
4
  28.6%
second hand smoke exposure during pregnancy  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
6
  42.9%
1.Primary Outcome
Title Change in Respiratory Resistance
Hide Description The primary outcome is the percentage of subjects who show a positive response to each dose of albuterol. A positive response is defined as a greater than or equal to 10% decrease in respiratory resistance (Rrs). The change in RRs was measured at baseline and again after each dose of albuterol. All measurements were taken within a 7 day time frame for each subject such that each subject would have up to 3 results measured during a 7 day period, if he/she were able to complete three sets of PFTs according to study protocol. The change in Rrs was calculated by subtracting the baseline Rrs from the post-albuterol Rrs.
Time Frame Within one week of performing pulmonary function tests
Hide Outcome Measure Data
Hide Analysis Population Description
Some subjects did not receive all 3 doses (based on how they tolerated initial dose(s))
Arm/Group Title Single Arm: Varied Albuterol Dose Response
Hide Arm/Group Description:

Subjects will be evaluated in 3 sessions. The sessions will occur within a 7 day time span, beginning after 14 days of age and at 28w0d to 33w6d corrected gestational age. In each session, pulmonary function tests (PFTs) will be performed prior to and 15 minutes after a dose of albuterol. The dose will be different in each session. In the first session, a single dose of 180 micrograms (2 puffs) of albuterol sulfate via metered dose inhaler. The dose will be 270 micrograms in the second session and 360 micrograms in the third session. PFTs will be performed during quiet sleep while the baby is spontaneously breathing or while the baby is intubated and receiving mechanical ventilation. Resistance and compliance will be measured using the single breath occlusion technique.

Varied albuterol dose response: Subjects will be evaluated in three sessions. The sessions will occur within a 7 day time span, beginning between 14 or more days from birth and at a corrected gestational age of 2

Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: cm h2o/mL/sec
dose 1 Number Analyzed 11 participants
0.011  (0.016)
dose 2 Number Analyzed 10 participants
0.006  (0.008)
dose 3 Number Analyzed 6 participants
0.014  (0.014)
2.Secondary Outcome
Title Number of Participants With Positive Response at Different Albuterol Doses
Hide Description Compare number of subjects who have a positive response (greater than or equal to 10% decrease in respiratory resistance) to each dose of albuterol
Time Frame Data collected 15 minutes after dose in each session. Study includes 3 sessions within a 7 day period.
Hide Outcome Measure Data
Hide Analysis Population Description
Measuring Rrs can be technically challenging, particularly in premature infants, and we did not have measurable Rrs for every subject at every time point, therefore the denominator here is not the same as the total number of participants. For example, we have missing/unmeasurable Rrs for 3 subjects at the lowest albuterol dose.
Arm/Group Title Single Arm: Varied Albuterol Dose Response
Hide Arm/Group Description:

Subjects will be evaluated in 3 sessions. The sessions will occur within a 7 day time span, beginning after 14 days of age and at 28w0d to 33w6d corrected gestational age. In each session, pulmonary function tests (PFTs) will be performed prior to and 15 minutes after a dose of albuterol. The dose will be different in each session. In the first session, a single dose of 180 micrograms (2 puffs) of albuterol sulfate via metered dose inhaler. The dose will be 270 micrograms in the second session and 360 micrograms in the third session. PFTs will be performed during quiet sleep while the baby is spontaneously breathing or while the baby is intubated and receiving mechanical ventilation. Resistance and compliance will be measured using the single breath occlusion technique.

Varied albuterol dose response: Subjects will be evaluated in 3 sessions. The sessions will occur within a 7 day time span, beginning between 14 or more days from birth and at a corrected gestational age of 28w0d to

Overall Number of Participants Analyzed 14
Measure Type: Number
Unit of Measure: participants
positive Rrs response at 180 mcg albuterol Number Analyzed 11 participants
6
positive Rrs response at 270 mcg albuterol Number Analyzed 10 participants
4
positive Rrs response at 360 mcg albuterol Number Analyzed 6 participants
4
3.Secondary Outcome
Title Birth Weight of Albuterol Responders vs Non Responders
Hide Description birth weight in grams of each subject was recorded at time of enrollment
Time Frame within one week of entering study
Hide Outcome Measure Data
Hide Analysis Population Description
This data included 10 subjects who responded to albuterol at at least one dose, and 3 subjects who did not show a positive response to albuterol at any dose
Arm/Group Title Single Arm: Varied Albuterol Dose Response
Hide Arm/Group Description:

Subjects will be evaluated in 3 sessions. The sessions will occur within a 7 day time span, beginning after 14 days of age and at 28w0d to 33w6d corrected gestational age. In each session, pulmonary function tests (PFTs) will be performed prior to and 15 minutes after a dose of albuterol. The dose will be different in each session. In the first session, a single dose of 180 micrograms (2 puffs) of albuterol sulfate via metered dose inhaler. The dose will be 270 micrograms in the second session and 360 micrograms in the third session. PFTs will be performed during quiet sleep while the baby is spontaneously breathing or while the baby is intubated and receiving mechanical ventilation. Resistance and compliance will be measured using the single breath occlusion technique.

Varied albuterol dose response: Subjects will be evaluated in 3 sessions. The sessions will occur within a 7 day time span, beginning between 14 or more days from birth and at a corrected gestational age of 28w0d to

Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: grams
albuterol responders Number Analyzed 10 participants
847.2  (296)
albuterol non responders Number Analyzed 3 participants
1147.7  (216)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Single Arm: Varied Albuterol Dose Response
Comments comparison of mean birth weights between responders and non-responders
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.14
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
4.Secondary Outcome
Title Gestational Age at Birth
Hide Description Average gestational age (GA) in weeks at birth for subjects who responded to albuterol versus subjects without a positive response
Time Frame within one week of entering study
Hide Outcome Measure Data
Hide Analysis Population Description
We have data for 10 subjects who responded to albuterol and 3 subjects who did not respond.
Arm/Group Title Single Arm: Varied Albuterol Dose Response
Hide Arm/Group Description:

Subjects will be evaluated in 3 sessions. The sessions will occur within a 7 day time span, beginning after 14 days of age and at 28w0d to 33w6d corrected gestational age. In each session, pulmonary function tests (PFTs) will be performed prior to and 15 minutes after a dose of albuterol. The dose will be different in each session. In the first session, a single dose of 180 micrograms (2 puffs) of albuterol sulfate via metered dose inhaler. The dose will be 270 micrograms in the second session and 360 micrograms in the third session. PFTs will be performed during quiet sleep while the baby is spontaneously breathing or while the baby is intubated and receiving mechanical ventilation. Resistance and compliance will be measured using the single breath occlusion technique.

Varied albuterol dose response: Subjects will be evaluated in 3 sessions. The sessions will occur within a 7 day time span, beginning between 14 or more days from birth and at a corrected gestational age of 28w0d to

Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: weeks
birth GA albuterol responders, weeks Number Analyzed 10 participants
26.7  (1.9)
birth GA albuterol non responders Number Analyzed 3 participants
28.5  (1.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Single Arm: Varied Albuterol Dose Response
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.16
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
5.Secondary Outcome
Title Etiology of Preterm Delivery
Hide Description Reason for each subject's preterm delivery was classified as either preterm labor or delivery for maternal indications (eg pre-eclampsia).
Time Frame within one week of entering study
Hide Outcome Measure Data
Hide Analysis Population Description
5 subjects were delivered due to preterm labor, and 8 delivered prematurely due to maternal indications
Arm/Group Title Single Arm: Varied Albuterol Dose Response
Hide Arm/Group Description:

Subjects will be evaluated in 3 sessions. The sessions will occur within a 7 day time span, beginning after 14 days of age and at 28w0d to 33w6d corrected gestational age. In each session, pulmonary function tests (PFTs) will be performed prior to and 15 minutes after a dose of albuterol. The dose will be different in each session. In the first session, a single dose of 180 micrograms (2 puffs) of albuterol sulfate via metered dose inhaler. The dose will be 270 micrograms in the second session and 360 micrograms in the third session. PFTs will be performed during quiet sleep while the baby is spontaneously breathing or while the baby is intubated and receiving mechanical ventilation. Resistance and compliance will be measured using the single breath occlusion technique.

Varied albuterol dose response: Subjects will be evaluated in three sessions. The sessions will occur within a 7 day time span, beginning between 14 or more days from birth and at a corrected gestational age of 2

Overall Number of Participants Analyzed 13
Measure Type: Count of Participants
Unit of Measure: Participants
preterm labor, responsive to albuterol Number Analyzed 5 participants
4
  80.0%
maternal indicated delivery, responsive to albuter Number Analyzed 8 participants
6
  75.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Single Arm: Varied Albuterol Dose Response
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
6.Other Pre-specified Outcome
Title Family History of Asthma and Likelihood to Respond to Albuterol
Hide Description Family history was obtained from verbal history by subject's mother at time of enrollment in study. A positive family history was noted if a first degree relative of the subject (infant) had a diagnosis of asthma.
Time Frame History collected at enrollment, albuterol response assessed within one week
Hide Outcome Measure Data
Hide Analysis Population Description
only 2 subjects had a history of a first-degree relative (parent or sibling) with asthma
Arm/Group Title Single Arm: Varied Albuterol Dose Response
Hide Arm/Group Description:

Subjects will be evaluated in 3 sessions. The sessions will occur within a 7 day time span, beginning after 14 days of age and at 28w0d to 33w6d corrected gestational age. In each session, pulmonary function tests (PFTs) will be performed prior to and 15 minutes after a dose of albuterol. The dose will be different in each session. In the first session, a single dose of 180 micrograms (2 puffs) of albuterol sulfate via metered dose inhaler. The dose will be 270 micrograms in the second session and 360 micrograms in the third session. PFTs will be performed during quiet sleep while the baby is spontaneously breathing or while the baby is intubated and receiving mechanical ventilation. Resistance and compliance will be measured using the single breath occlusion technique.

Varied albuterol dose response: Subjects will be evaluated in three sessions. The sessions will occur within a 7 day time span, beginning between 14 or more days from birth and at a corrected gestational age of 2

Overall Number of Participants Analyzed 14
Measure Type: Number
Unit of Measure: participants
family hx of asthma, respond to albuterol Number Analyzed 2 participants
1
no fam hx asthma, respond to albuterol Number Analyzed 12 participants
9
7.Other Pre-specified Outcome
Title Maternal BMI at Time of Pregnancy and Likelihood of Positive Response to Albuterol
Hide Description Maternal BMI will be obtained from her medial record, and she will be asked about weight gain during pregnancy at time of enrollment. Results will be compared for infants born to women with a normal BMI vs. those with obese BMI (>30).
Time Frame Maternal information collected at enrollment; albuterol response assessed within one week
Hide Outcome Measure Data
Hide Analysis Population Description
We have BMI data on 13 mothers.
Arm/Group Title Single Arm: Varied Albuterol Dose Response
Hide Arm/Group Description:

Subjects will be evaluated in 3 sessions. The sessions will occur within a 7 day time span, beginning after 14 days of age and at 28w0d to 33w6d corrected gestational age. In each session, pulmonary function tests (PFTs) will be performed prior to and 15 minutes after a dose of albuterol. The dose will be different in each session. In the first session, a single dose of 180 micrograms (2 puffs) of albuterol sulfate via metered dose inhaler. The dose will be 270 micrograms in the second session and 360 micrograms in the third session. PFTs will be performed during quiet sleep while the baby is spontaneously breathing or while the baby is intubated and receiving mechanical ventilation. Resistance and compliance will be measured using the single breath occlusion technique.

Varied albuterol dose response: Subjects will be evaluated in 3 sessions. The sessions will occur within a 7 day time span, beginning between 14 or more days from birth and at a corrected gestational age of 28w0d to

Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: kg/m^2
mean BMI mothers of albuterol-responders , any dos Number Analyzed 10 participants
27.4  (8.6)
mean BMI mothers of albuterol non-responders Number Analyzed 3 participants
27.3  (3.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Single Arm: Varied Albuterol Dose Response
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
8.Other Pre-specified Outcome
Title Association of Smoke Exposure During Pregnancy and Neonatal Response to Albuterol
Hide Description Mothers who smoked cigarettes during pregnancy and the rate of albuterol response of their infants
Time Frame Smoking and second hand smoke exposure history will be obtained at enrollment. Albuterol response will be obtained within one week.
Hide Outcome Measure Data
Hide Analysis Population Description
We have data for 9 subjects whose mothers did not smoke and 4 subjects whose mothers smoked
Arm/Group Title Single Arm: Varied Albuterol Dose Response
Hide Arm/Group Description:

Subjects will be evaluated in 3 sessions. The sessions will occur within a 7 day time span, beginning after 14 days of age and at 28w0d to 33w6d corrected gestational age. In each session, pulmonary function tests (PFTs) will be performed prior to and 15 minutes after a dose of albuterol. The dose will be different in each session. In the first session, a single dose of 180 micrograms (2 puffs) of albuterol sulfate via metered dose inhaler. The dose will be 270 micrograms in the second session and 360 micrograms in the third session. PFTs will be performed during quiet sleep while the baby is spontaneously breathing or while the baby is intubated and receiving mechanical ventilation. Resistance and compliance will be measured using the single breath occlusion technique.

Varied albuterol dose response: Subjects will be evaluated in 3 sessions. The sessions will occur within a 7 day time span, beginning between 14 or more days from birth and at a corrected gestational age of 28w0d to

Overall Number of Participants Analyzed 13
Measure Type: Number
Unit of Measure: participants
albuterol responders of mothers who smoked Number Analyzed 4 participants
4
albuterol responders of non-smoker mothers % Number Analyzed 9 participants
6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Single Arm: Varied Albuterol Dose Response
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.50
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Single Arm: Varied Albuterol Dose Response
Hide Arm/Group Description

Subjects will be evaluated in 3 sessions. The sessions will occur within a 7 day time span, beginning after 14 days of age and at 28w0d to 33w6d corrected gestational age. In each session, pulmonary function tests (PFTs) will be performed prior to and 15 minutes after a dose of albuterol. The dose will be different in each session. In the first session, a single dose of 180 micrograms (2 puffs) of albuterol sulfate via metered dose inhaler. The dose will be 270 micrograms in the second session and 360 micrograms in the third session. Resistance and compliance will be measured using the single breath occlusion technique.

Varied albuterol dose response: Subjects will be evaluated in 3 sessions. The sessions will occur within a 7 day time span, beginning between 14 or more days from birth and at a corrected gestational age of 28w0d to

All-Cause Mortality
Single Arm: Varied Albuterol Dose Response
Affected / at Risk (%)
Total   0/14 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Single Arm: Varied Albuterol Dose Response
Affected / at Risk (%) # Events
Total   0/14 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Single Arm: Varied Albuterol Dose Response
Affected / at Risk (%) # Events
Total   1/14 (7.14%)    
Cardiac disorders   
elevated heart rate above predefined criteria   1/14 (7.14%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Cindy McEvoy, MD
Organization: OHSU
Phone: 5034940223
EMail: mcevoyc@ohsu.edu
Layout table for additonal information
Responsible Party: Cynthia McEvoy, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT02447250     History of Changes
Other Study ID Numbers: IRB00009883
First Submitted: May 14, 2015
First Posted: May 18, 2015
Results First Submitted: October 16, 2018
Results First Posted: May 23, 2019
Last Update Posted: May 23, 2019