Effect of Inhaled Albuterol in Pulmonary Hypertension

• Sponsor: University of Miami (Other)
• Overall Status: Completed
• CT.gov ID: NCT03270332
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arms: 2
• Actual Duration (Months): 32.9
• Patients Per Site Per Month: 0.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Hypertension	Drug: Albuterol; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• 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: Oct 5, 2017
• Actual Primary Completion Date: Jul 2, 2020
• Actual Study Completion Date: Jul 2, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. Change in Pulmonary Vascular Resistance (PVR) [Baseline, up to 30 minutes after inhalation]

   Change in PVR will be measured using echocardiogram

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Miami	Miami	Florida	United States	33136

Sponsors and Collaborators

• University of Miami

Investigators

• Principal Investigator: Adam Wanner, MD, University of Miami

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 4, 2021

More Information

Publications

None provided.

• Responsible Party: Adam Wanner, Professor of Medicine, University of Miami
• ClinicalTrials.gov Identifier: NCT03270332
• Other Study ID Numbers: 20170552
• First Posted: Sep 1, 2017
• Last Update Posted: Aug 30, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Hypertension, Pulmonary; Hypertension; Albuterol

Study Results

Participant Flow

Arm/Group Title	Albuterol Followed by Placebo	Placebo Followed by Albuterol
Arm/Group Description	Participants in this group will receive albuterol first followed by Placebo on the next visit Albuterol: inhalation of 270μg albuterol through a spacer Placebo: inhalation of placebo through a spacer	Participants in this group will receive placebo first followed by albuterol on the next visit Albuterol: inhalation of 270μg albuterol through a spacer Placebo: inhalation of placebo through a spacer
Period Title: Overall Study
STARTED	5	5
COMPLETED	5	4
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	Albuterol Followed by Placebo	Placebo Followed by Albuterol	Total
Arm/Group Description	Participants in this group will receive albuterol first followed by Placebo on the next visit Albuterol: inhalation of 270μg albuterol through a spacer Placebo: inhalation of placebo through a spacer	Participants in this group will receive placebo first followed by albuterol on the next visit Albuterol: inhalation of 270μg albuterol through a spacer Placebo: inhalation of placebo through a spacer	Total of all reporting groups
Overall Participants	5	5	10
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	5 100%	5 100%	10 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	4 80%	5 100%	9 90%
Male	1 20%	0 0%	1 10%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 40%	1 20%	3 30%
Not Hispanic or Latino	3 60%	3 60%	6 60%
Unknown or Not Reported	0 0%	1 20%	1 10%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 20%	3 60%	4 40%
White	4 80%	2 40%	6 60%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

This is a cross-over study design. All enrolled participants received both the albuterol and placebo intervention.

Arm/Group Title	Albuterol Group	Placebo Group
Arm/Group Description	This is a cross-over study design. All participants received albuterol	This is a cross-over design. All participants received placebo.
Measure Participants	9	9
Mean (Standard Error) [mmHg]	6.5 (2.8)	4.3 (3.0)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

This is a cross-over study design. All enrolled participants received both the albuterol and placebo intervention.

Arm/Group Title	Albuterol Group	Placebo Group
Arm/Group Description	This is a cross-over study. All participants received albuterol.	This is a cross-over study. All participants received placebo.
Measure Participants	9	9
Mean (Standard Error) [dyn.s.cm-5]	217 (92)	108 (153)

Adverse Events

Time Frame	1 day
Arm/Group Title	Albuterol Group		Placebo Group
Arm/Group Description	This is a cross-over study. All participants received albuterol.		This is a cross-over study. All participants received placebo.
All Cause Mortality
	Albuterol Group		Placebo Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)
Serious Adverse Events
	Albuterol Group		Placebo Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	Albuterol Group		Placebo Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.