Pulmonary Hypertension
Conditions
Brief summary
The purpose of the present pilot study is to test the hypothesis that in patients with group 1 pulmonary arterial hypertension (PAH) who are on regular oral pulmonary vasodilator therapy, inhaled albuterol causes transient pulmonary vasodilation.
Interventions
DRUGAlbuterol
inhalation of 270μg albuterol through a spacer
DRUGPlacebo
inhalation of placebo through a spacer
Sponsors
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A Mean Pulmonary Artery Pressure \>25mmHg, Pulmonary Vascular Resistance \>3 wood/units and pulmonary arterial wedge pressure \<15mmHg, as documented by right heart catheterization within the last 3 years * Regular use of oral pulmonary vasodilators
Exclusion criteria
* Presence of chronic respiratory disease (as documented by prior lung imaging and pulmonary function tests), cardiovascular disease (as documented by prior echocardiography and/or left heart catheterization), thromboembolic PAH (as documented by pulmonary angiography) * women of childbearing potential who do not use accepted birth- control measures * pregnant and breast-feeding women * respiratory infection within 4 weeks of testing * A systemic systolic arterial BP\> 150 and/or diastolic arterial BP\>100 on the experiment day * A resting O2 saturation of \< 90% * Current smoking * BMI \>35 kg/m2 and/or a diagnosis of obstructive sleep apnea * Use of inhaled or intravenous pulmonary vasodilators
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mean Pulmonary Artery Pressure (MPAP) | Baseline, up to 30 minutes after inhalation | Change in MPAP will be measured using echocardiogram |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pulmonary Vascular Resistance (PVR) | Baseline, up to 30 minutes after inhalation | Change in PVR will be measured using echocardiogram |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 5 |
| 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 | 5 |
| Total | 10 |
Baseline characteristics
| Characteristic | Albuterol Followed by Placebo | Placebo Followed by Albuterol | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 5 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 3 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 2 Participants | 6 Participants |
| Sex: Female, Male Female | 4 Participants | 5 Participants | 9 Participants |
| Sex: Female, Male Male | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
Change in Mean Pulmonary Artery Pressure (MPAP)
Change in MPAP will be measured using echocardiogram
Time frame: Baseline, up to 30 minutes after inhalation
Population: This is a cross-over study design. All enrolled participants received both the albuterol and placebo intervention.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Albuterol Group | Change in Mean Pulmonary Artery Pressure (MPAP) | 6.5 mmHg | Standard Error 2.8 |
| Placebo Group | Change in Mean Pulmonary Artery Pressure (MPAP) | 4.3 mmHg | Standard Error 3 |
Secondary
Change in Pulmonary Vascular Resistance (PVR)
Change in PVR will be measured using echocardiogram
Time frame: Baseline, up to 30 minutes after inhalation
Population: This is a cross-over study design. All enrolled participants received both the albuterol and placebo intervention.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Albuterol Group | Change in Pulmonary Vascular Resistance (PVR) | 217 dyn.s.cm-5 | Standard Error 92 |
| Placebo Group | Change in Pulmonary Vascular Resistance (PVR) | 108 dyn.s.cm-5 | Standard Error 153 |