Trial Outcomes & Findings for Effect of Inhaled Albuterol in Pulmonary Hypertension (NCT NCT03270332)
NCT ID: NCT03270332
Last Updated: 2021-08-30
Results Overview
Change in MPAP will be measured using echocardiogram
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
Baseline, up to 30 minutes after inhalation
Results posted on
2021-08-30
Participant Flow
Participant milestones
| Measure |
Albuterol Followed by Placebo
Participants in this group will receive albuterol first followed by Placebo on the next visit
Albuterol: inhalation of 270μg albuterol through a spacer
Placebo: inhalation of placebo through a spacer
|
Placebo Followed by Albuterol
Participants in this group will receive placebo first followed by albuterol on the next visit
Albuterol: inhalation of 270μg albuterol through a spacer
Placebo: inhalation of placebo through a spacer
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
|
Overall Study
COMPLETED
|
5
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Inhaled Albuterol in Pulmonary Hypertension
Baseline characteristics by cohort
| Measure |
Albuterol Followed by Placebo
n=5 Participants
Participants in this group will receive albuterol first followed by Placebo on the next visit
Albuterol: inhalation of 270μg albuterol through a spacer
Placebo: inhalation of placebo through a spacer
|
Placebo Followed by Albuterol
n=5 Participants
Participants in this group will receive placebo first followed by albuterol on the next visit
Albuterol: inhalation of 270μg albuterol through a spacer
Placebo: inhalation of placebo through a spacer
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline, up to 30 minutes after inhalationPopulation: This is a cross-over study design. All enrolled participants received both the albuterol and placebo intervention.
Change in MPAP will be measured using echocardiogram
Outcome measures
| Measure |
Albuterol Group
n=9 Participants
This is a cross-over study design. All participants received albuterol
|
Placebo Group
n=9 Participants
This is a cross-over design. All participants received placebo.
|
|---|---|---|
|
Change in Mean Pulmonary Artery Pressure (MPAP)
|
6.5 mmHg
Standard Error 2.8
|
4.3 mmHg
Standard Error 3.0
|
SECONDARY outcome
Timeframe: Baseline, up to 30 minutes after inhalationPopulation: This is a cross-over study design. All enrolled participants received both the albuterol and placebo intervention.
Change in PVR will be measured using echocardiogram
Outcome measures
| Measure |
Albuterol Group
n=9 Participants
This is a cross-over study design. All participants received albuterol
|
Placebo Group
n=9 Participants
This is a cross-over design. All participants received placebo.
|
|---|---|---|
|
Change in Pulmonary Vascular Resistance (PVR)
|
217 dyn.s.cm-5
Standard Error 92
|
108 dyn.s.cm-5
Standard Error 153
|
Adverse Events
Albuterol Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Group
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place