Albuterol and Dynamic Hyperinflation in Idiopathic Pulmonary Arterial Hypertension

Phase 2

Withdrawn

• Conditions: Idiopathic Pulmonary Arterial Hypertension.
• Interventions: Drug: Albuterol.; Drug: Normal saline placebo

• Registration Number: NCT02108743
• Lead Sponsor: American Medical Association Foundation

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2014-04-07
• Study First Submitted QC: 2014-04-08
• Study First Posted: 2014-04-09
• Study Start: 2014-06
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-29
• Last Update Posted: 2015-12-30
• Primary Completion: 2016-07
• Study Completion: 2016-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Albuterol	Albuterol.	2.5 mg of albuterol inhaled via jet nebulizer 15 minutes prior to symptom-limited maximal CPET.
Placebo	Normal saline placebo	Normal saline placebo inhaled via jet nebulizer 15 minutes prior to symptom-limited maximal CPET.

Primary Outcome Measures

Name	Time	Method
End-expiratory lung volume:total lung capacity (EELV/TLC) ratio at matched metabolic isowork.	up to 3 days	Determined by measuring inspiratory capacity every 2 minutes during cardiopulmonary exercise test (CPET)

Secondary Outcome Measures

Name	Time	Method
Change in peak oxygen consumption with albuterol	Study days 2 and 3	Measured at the end of CPET
Change in O2 pulse with albuterol.	Study days 2 and 3	Measured throughout CPET and compared at matched metabolic isotimes
Borg dyspnea score	Days 2 and 3	Measured every 2 minutes throughout CPET
Exercise time	Study days 2 and 3	Total ramped exercise time

Trial Locations

Locations (1)

LSUHSC Interim Louisiana Hospital; 🇺🇸 New Orleans, Louisiana, United States