Clinical Trials

Effect of Inhaled Albuterol in Pulmonary Hypertension

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03270332
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Early Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Miami
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Adam Wanner, MD
Principal Investigator Affiliation	University of Miami
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pulmonary Hypertension

Additional Details

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.

Arms & Interventions

Arms

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

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

Interventions

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

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Miami, Florida

Status

Recruiting

Address

Pulmonary Human Research Laboratory, University of Miami, Miller School of Medicine

Miami, Florida, 33136

Site Contact

Eliana Mendes, MD

emendes@med.miami.edu

305-243-2568