Albuterol and Dynamic Hyperinflation in Idiopathic Pulmonary Arterial Hypertension

American Medical Association Foundation

Status and phase: Withdrawn; Phase 2

Conditions: Idiopathic Pulmonary Arterial Hypertension.

Treatments: Drug: Normal saline placebo; Drug: Albuterol.

Study type: Interventional

Funder types: Other

Identifiers

NCT02108743

IRB8603

Details and patient eligibility

About

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

Full description

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.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Albuterol

Active Comparator group

Description:

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

Treatment:

Drug: Albuterol.

Placebo

Placebo Comparator group

Description:

Normal saline placebo inhaled via jet nebulizer 15 minutes prior to symptom-limited maximal CPET.

Treatment:

Drug: Normal saline placebo