Effect of Inhaled Albuterol in Pulmonary Hypertension

Pulmonary Hypertension Clinical Trial

Official title:

Effect of Inhaled Albuterol on Pulmonary Hemodynamics in Patients With Group 1 Pulmonary Arterial Hypertension on Oral Pulmonary Vasodilator Therapy: A Proof of Concept Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03270332
• Other study ID #: 20170552
• Status: Completed
• Phase: Phase 2
• Start date: October 5, 2017
• Est. completion date: July 2, 2020

Study information

• Verified date: August 2021
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 2, 2020
• Est. primary completion date: July 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Drug:
• Albuterol
inhalation of 270µg albuterol through a spacer
• Placebo
inhalation of placebo through a spacer

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Mean Pulmonary Artery Pressure (MPAP)	Change in MPAP will be measured using echocardiogram	Baseline, up to 30 minutes after inhalation
Secondary	Change in Pulmonary Vascular Resistance (PVR)	Change in PVR will be measured using echocardiogram	Baseline, up to 30 minutes after inhalation