Albuterol and Dynamic Hyperinflation in Idiopathic Pulmonary Arterial Hypertension

American Medical Association Foundation

Overview

The purpose of this study is to determine if dynamic hyperinflation seen in patients with idiopathic pulmonary artery hypertension (iPAH) improves with albuterol therapy.

Only a few small studies have evaluated the relationship between iPAH, expiratory flow limitation, and exercise dyspnea. While not all patients with iPAH demonstrate airway involvement, those who demonstrate dynamic hyperinflation (DH), defined as a variable and temporary increase in end-expiratory lung volume, report increased dyspnea with exertion on maximal testing. There is a continued need for adjuvant therapy in iPAH, and bronchodilators have the potential to ameliorate dyspnea during exercise, which could lead to improved quality of life in this disabling condition. This study will investigate the presence of airway involvement in this population as measured by dynamic hyperinflation, and if there is any improvement in function with the use of inhaled albuterol.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

Idiopathic Pulmonary Arterial Hypertension.

Interventions

Albuterol.DRUG

2.5 mg of albuterol inhaled via jet nebulizer 15 minutes prior to symptom-limited maximal CPET.

Normal saline placeboDRUG

Placebo inhaled via jet nebulizer 15 minutes prior to symptom-limited maximal CPET.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 18 years of age or greater. * Idiopathic Pulmonary Arterial Hypertension, or Familial Pulmonary Arterial Hypertension. * Forced expiratory flow 75% (FEF75%) of ≤ 65% of predicted. Exclusion Criteria: * Clinical instability or change in medication therapy in preceding 3 months. * Allergy or intolerance to inhaled albuterol. * Body mass index \> 30 * Active tobacco use, or \> 10 pack-year smoking history. * Lung disease other than pulmonary hypertension * Forced expiratory volume in 1 second (FEV1) ≤ 80% of predicted. * Pregnancy * Inability to perform pulmonary function testing. * Inability to perform cardiopulmonary exercise testing. * Supplemental oxygen requirement. * Inability to read and understand English. * Historical 6-minute walk distance \<150 meters

Locations (1)

LSUHSC Interim Louisiana Hospital

New Orleans, Louisiana, United States

Outcomes

Primary Outcomes

End-expiratory lung volume:total lung capacity (EELV/TLC) ratio at matched metabolic isowork.

Determined by measuring inspiratory capacity every 2 minutes during cardiopulmonary exercise test (CPET)

Time frame: up to 3 days

Secondary Outcomes

Change in peak oxygen consumption with albuterol

Measured at the end of CPET

Time frame: Study days 2 and 3

Change in O2 pulse with albuterol.

Measured throughout CPET and compared at matched metabolic isotimes

Time frame: Study days 2 and 3

Exercise time

Total ramped exercise time

Time frame: Study days 2 and 3

Borg dyspnea score

Measured every 2 minutes throughout CPET

Time frame: Days 2 and 3

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.