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Trial record 7 of 857 for:    ALBUTEROL

Effect of Inhaled Albuterol in Pulmonary Hypertension

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ClinicalTrials.gov Identifier: NCT03270332
Recruitment Status : Recruiting
First Posted : September 1, 2017
Last Update Posted : August 6, 2019
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. If the results support this premise, they could serve as the basis for a phase 2 trial investigating the potential for using inhaled long-acting β2-adrenergic agonists as add-on therapy in group 1 PAH. Echocardiography will be performed before and after administration of inhaled albuterol.

Condition or disease Intervention/treatment Phase
Pulmonary Hypertension Drug: albuterol first then placebo Drug: placebo first then albuterol Early Phase 1

Detailed Description:
The Investigators will use echocardiography to assess the acute pulmonary hemodynamic effect of albuterol in 6 patients with group 1 PAH documented by right heart catheterization (mean pulmonary arterial pressure >25mmHg, pulmonary vascular resistance (PVR) > 3 wood/u and pulmonary wedge pressure <15). The patients will be on regular oral pulmonary vasodilator therapy. Mean pulmonary arterial pressure (MPAP) and cardiac output will be measured before and serially for 2 hours after the administration of either 270μg albuterol or placebo by inhalation using a spacer. PVR will be calculated by using an estimate of left atrial pressure.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: The patients will be randomized to receive either placebo or albuterol on visit 2 and the alternate treatment on visit 3
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: double-blind
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 12, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : March 30, 2020


Arm Intervention/treatment
Experimental: albuterol first then placebo
For albuterol first then placebo, echocardiographic measurements will be made before and at 15, 30, 60, and 120 min after inhaled albuterol (270ug) at visit 2, and echocardiographic measurements before and at 15, 30, 60, and 120 min after inhaled placebo at visit 3
Drug: albuterol first then placebo
inhalation of 270μg albuterol (3 puffs) through a spacer at visit 2 and inhalation of placebo (3 puffs) through a spacer at visit 3

Experimental: placebo first then albuterol
For placebo first then albuterol, echocardiographic measurements will be made before and at 15, 30, 60, and 120 min after inhaled placebo at visit 2 and inhaled albuterol (270ug) at visit 3
Drug: placebo first then albuterol
inhalation of placebo(3 puffs) through a spacer at visit 2 and inhalation of 270ug albuterol (3 puffs) through a spacer at visit 3




Primary Outcome Measures :
  1. Mean Pulmonary Artery Pressure [ Time Frame: before and at 15, 30, 60 and 120 after albuterol or placebo inhalation ]
    Maximum change in mean pulmonary arterial pressure from before to after the inhalation of 270ug albuterol relative to placebo


Secondary Outcome Measures :
  1. Pulmonary Vascular Resistance [ Time Frame: before and at 15, 30, 60 and 120 after albuterol or placebo inhalation ]
    Maximum change in pulmonary vascular resistance from before to after the inhalation of 270ug albuterol relative to placebo



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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


Contacts
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Contact: Adam Wanner, MD (305)243-3045 awanner@med.miami.edu
Contact: David De La Zerda, MD (305) 243-2568 ddelazerda@med.miami.edu

Locations
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United States, Florida
Pulmonary Human Research Laboratory, University of Miami, Miller School of Medicine Recruiting
Miami, Florida, United States, 33136
Contact: Eliana Mendes, MD    305-243-2568    emendes@med.miami.edu   
Contact: Adam Wanner, MD    (305) 243-2568    awanner@miami.edu   
Principal Investigator: Adam Wanner, MD         
Sponsors and Collaborators
University of Miami
Investigators
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Principal Investigator: Adam Wanner, MD University of Miami

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Responsible Party: Adam Wanner, Professor of Medicine, University of Miami
ClinicalTrials.gov Identifier: NCT03270332     History of Changes
Other Study ID Numbers: 20170552
First Posted: September 1, 2017    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019
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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Albuterol
Hypertension, Pulmonary
Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
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