Effect of Inhaled Albuterol in Pulmonary Hypertension

NCT03270332 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 20170552
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

• Change in Mean Pulmonary Artery Pressure (MPAP)

  Change in MPAP will be measured using echocardiogram

  Baseline, up to 30 minutes after inhalation

Secondary Outcomes (1)

• Change in Pulmonary Vascular Resistance (PVR)

  Baseline, up to 30 minutes after inhalation

Study Arms (2)

Albuterol followed by placebo

EXPERIMENTAL

Participants in this group will receive albuterol first followed by Placebo on the next visit

Drug: Albuterol; Drug: Placebo

Placebo followed by albuterol

EXPERIMENTAL

Participants in this group will receive placebo first followed by albuterol on the next visit

Drug: Albuterol; Drug: Placebo

Interventions

Albuterol DRUG

inhalation of 270μg albuterol through a spacer

Albuterol followed by placebo; Placebo followed by albuterol

Placebo DRUG

inhalation of placebo through a spacer

Albuterol followed by placebo; Placebo followed by albuterol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Albuterol

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Results Point of Contact

• Title: Dr. Adam Wanner
• Organization: University of Miami

awanner@miami.edu

3053010563

Study Officials

• Adam Wanner, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: August 30, 2017
• First Posted: September 1, 2017
• Study Start: October 5, 2017
• Primary Completion: July 2, 2020
• Study Completion: July 2, 2020
• Last Updated: August 30, 2021
• Results First Posted: August 30, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)