Effect of Inhaled Albuterol in Pulmonary Hypertension

University of Miami

Status and phase: Completed; Phase 2

Conditions: Pulmonary Hypertension

Treatments: Drug: Placebo; Drug: Albuterol

Study type: Interventional

Funder types: Other

Identifiers

NCT03270332

20170552

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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10 participants in 2 patient groups

Albuterol followed by placebo

Experimental group

Description:

Participants in this group will receive albuterol first followed by Placebo on the next visit

Treatment:

Drug: Placebo

Drug: Albuterol

Placebo followed by albuterol

Experimental group

Description:

Participants in this group will receive placebo first followed by albuterol on the next visit

Treatment:

Drug: Placebo

Drug: Albuterol