Effect of Inhaled Albuterol in Pulmonary Hypertension

Phase 2

Completed

• Conditions: Pulmonary Hypertension
• Interventions: Drug: Albuterol; Drug: Placebo

• Registration Number: NCT03270332
• Lead Sponsor: University of Miami

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-08-30
• Study First Submitted QC: 2017-08-30
• Study First Posted: 2017-09-01
• Study Start: 2017-10-05
• Primary Completion: 2020-07-02
• Study Completion: 2020-07-02
• Status Verified: 2021-08
• Results First Submitted: 2021-08-04
• Results First Submitted QC: 2021-08-04
• Last Update Submitted: 2021-08-04
• Results First Posted: 2021-08-30
• Last Update Posted: 2021-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Albuterol followed by placebo	Placebo	Participants in this group will receive albuterol first followed by Placebo on the next visit
Placebo followed by albuterol	Placebo	Participants in this group will receive placebo first followed by albuterol on the next visit
Albuterol followed by placebo	Albuterol	Participants in this group will receive albuterol first followed by Placebo on the next visit
Placebo followed by albuterol	Albuterol	Participants in this group will receive placebo first followed by albuterol on the next visit

Primary Outcome Measures

Name	Time	Method
Change in Mean Pulmonary Artery Pressure (MPAP)	Baseline, up to 30 minutes after inhalation	Change in MPAP will be measured using echocardiogram

Secondary Outcome Measures

Name	Time	Method
Change in Pulmonary Vascular Resistance (PVR)	Baseline, up to 30 minutes after inhalation	Change in PVR will be measured using echocardiogram

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States