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Completed

NCT Number: NCT03270332

Effect of Inhaled Albuterol in Pulmonary Hypertension

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.

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Key information

Conditions

Pulmonary Hypertension Cardiovascular Diseases Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

albuterol

Drug

inhalation of 270μg albuterol through a spacer

Placebo

Drug

inhalation of placebo through a spacer

Primary outcomes

  1. Change in Mean Pulmonary Artery Pressure (MPAP)

    Time frame: Baseline, up to 30 minutes after inhalation

    Change in MPAP will be measured using echocardiogram

Secondary outcomes

  1. Change in Pulmonary Vascular Resistance (PVR)

    Time frame: Baseline, up to 30 minutes after inhalation

    Change in PVR will be measured using echocardiogram

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Sep 1, 2017
Registry last updated
Aug 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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