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Effect of Inhaled Albuterol in Pulmonary Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03270332
Recruitment Status : Completed
First Posted : September 1, 2017
Results First Posted : August 30, 2021
Last Update Posted : August 30, 2021
Sponsor:
Information provided by (Responsible Party):
Adam Wanner, 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.

Condition or disease Intervention/treatment Phase
Pulmonary Hypertension Drug: Albuterol Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : October 5, 2017
Actual Primary Completion Date : July 2, 2020
Actual Study Completion Date : July 2, 2020


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




Primary Outcome Measures :
  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 Outcome Measures :
  1. Change in Pulmonary Vascular Resistance (PVR) [ Time Frame: Baseline, up to 30 minutes after inhalation ]
    Change in PVR will be measured using echocardiogram



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03270332


Locations
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United States, Florida
University of Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Investigators
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Principal Investigator: Adam Wanner, MD University of Miami
  Study Documents (Full-Text)

Documents provided by Adam Wanner, University of Miami:
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Responsible Party: Adam Wanner, Professor of Medicine, University of Miami
ClinicalTrials.gov Identifier: NCT03270332    
Other Study ID Numbers: 20170552
First Posted: September 1, 2017    Key Record Dates
Results First Posted: August 30, 2021
Last Update Posted: August 30, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Albuterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action