Effect of Inhaled Albuterol in Pulmonary Hypertension

NCT ID: NCT03270332

Last Updated: 2021-08-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-05

Study Completion Date

2020-07-02

Brief Summary

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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.

Detailed Description

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Conditions

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Pulmonary Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Albuterol followed by placebo

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

Group Type EXPERIMENTAL

Albuterol

Intervention Type DRUG

inhalation of 270μg albuterol through a spacer

Placebo

Intervention Type DRUG

inhalation of placebo through a spacer

Placebo followed by albuterol

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

Group Type EXPERIMENTAL

Albuterol

Intervention Type DRUG

inhalation of 270μg albuterol through a spacer

Placebo

Intervention Type DRUG

inhalation of placebo through a spacer

Interventions

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Albuterol

inhalation of 270μg albuterol through a spacer

Intervention Type DRUG

Placebo

inhalation of placebo through a spacer

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Adam Wanner

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Adam Wanner, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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University of Miami

Miami, Florida, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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20170552

Identifier Type: -

Identifier Source: org_study_id

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