Effect of Inhaled Albuterol in Pulmonary Hypertension

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

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Hypertension
• Intervention / Treatment: Drug: Albuterol; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Albuterol followed by placebo; Participants in this group will receive albuterol first followed by Placebo on the next visit	Drug: Albuterol; inhalation of 270μg albuterol through a spacer; Drug: Placebo; inhalation of placebo through a spacer
Experimental: Placebo followed by albuterol; Participants in this group will receive placebo first followed by albuterol on the next visit	Drug: Albuterol; inhalation of 270μg albuterol through a spacer; Drug: Placebo; inhalation of placebo through a spacer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Mean Pulmonary Artery Pressure (MPAP)	Change in MPAP will be measured using echocardiogram	Baseline, up to 30 minutes after inhalation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pulmonary Vascular Resistance (PVR)	Change in PVR will be measured using echocardiogram	Baseline, up to 30 minutes after inhalation

Collaborators and Investigators

• Sponsor: University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2017
• Primary Completion (Actual): July 2, 2020
• Study Completion (Actual): July 2, 2020

Study Registration Dates

• First Submitted: August 30, 2017
• First Submitted That Met QC Criteria: August 30, 2017
• First Posted (Actual): September 1, 2017

Study Record Updates

• Last Update Posted (Actual): August 30, 2021
• Last Update Submitted That Met QC Criteria: August 4, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Reproductive Control Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Tocolytic Agents; Albuterol
• Other Study ID Numbers: 20170552

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No