Back to resultsEffect of Inhaled Albuterol in Pulmonary Hypertension
Primary Purpose
Pulmonary Hypertension
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Albuterol
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Hypertension
Eligibility 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
Sites / Locations
- University of Miami
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Albuterol followed by placebo
Placebo followed by albuterol
Arm Description
Participants in this group will receive albuterol first followed by Placebo on the next visit
Participants in this group will receive placebo first followed by albuterol on the next visit
Outcomes
Primary Outcome Measures
Change in Mean Pulmonary Artery Pressure (MPAP)
Change in MPAP will be measured using echocardiogram
Secondary Outcome Measures
Change in Pulmonary Vascular Resistance (PVR)
Change in PVR will be measured using echocardiogram
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03270332
Brief Title
Effect of Inhaled Albuterol in Pulmonary Hypertension
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
October 5, 2017 (Actual)
Primary Completion Date
July 2, 2020 (Actual)
Study Completion Date
July 2, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Albuterol followed by placebo
Arm Type
Experimental
Arm Description
Participants in this group will receive albuterol first followed by Placebo on the next visit
Arm Title
Placebo followed by albuterol
Arm Type
Experimental
Arm Description
Participants in this group will receive placebo first followed by albuterol on the next visit
Intervention Type
Drug
Intervention Name(s)
Albuterol
Intervention Description
inhalation of 270μg albuterol through a spacer
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
inhalation of placebo through a spacer
Primary Outcome Measure Information:
Title
Change in Mean Pulmonary Artery Pressure (MPAP)
Description
Change in MPAP will be measured using echocardiogram
Time Frame
Baseline, up to 30 minutes after inhalation
Secondary Outcome Measure Information:
Title
Change in Pulmonary Vascular Resistance (PVR)
Description
Change in PVR will be measured using echocardiogram
Time Frame
Baseline, up to 30 minutes after inhalation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam Wanner, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Inhaled Albuterol in Pulmonary Hypertension
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