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Albuterol and Dynamic Hyperinflation in Idiopathic Pulmonary Arterial Hypertension

Information source: American Medical Association Foundation
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Idiopathic Pulmonary Arterial Hypertension.

Intervention: Albuterol. (Drug); Normal saline placebo (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: American Medical Association Foundation

Official(s) and/or principal investigator(s):
Matthew Lammi, MD, Principal Investigator, Affiliation: Louisiana State University Health Sciences Center in New Orleans

Overall contact:
Matthew Lammi, MD, Phone: 504-568-4634, Email: mlammi@lsuhsc.edu


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

Clinical Details

Official title: Albuterol and Dynamic Hyperinflation in Idiopathic Pulmonary Arterial Hypertension

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

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

Secondary outcome:

Change in peak oxygen consumption with albuterol

Change in O2 pulse with albuterol.

Exercise time

Borg dyspnea score

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.


Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.


Inclusion Criteria:

- 18 years of age or greater.

- Idiopathic Pulmonary Arterial Hypertension, or Familial Pulmonary Arterial


- 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 and Contacts

Matthew Lammi, MD, Phone: 504-568-4634, Email: mlammi@lsuhsc.edu

LSUHSC Interim Louisiana Hospital, New Orleans, Louisiana 70112, United States; Recruiting
Matthew Lammi, MD, Phone: 504-568-4634, Email: mlammi@lsuhsc.edu
Matthew Lammi, MD, Principal Investigator
Brianne Aiello, MD, Sub-Investigator
Jessica Johnson, PharmD, Sub-Investigator
Bennett deBoisblanc, MD, Sub-Investigator
Additional Information

Related publications:

Meyer FJ, Ewert R, Hoeper MM, Olschewski H, Behr J, Winkler J, Wilkens H, Breuer C, Kübler W, Borst MM; German PPH Study Group. Peripheral airway obstruction in primary pulmonary hypertension. Thorax. 2002 Jun;57(6):473-6.

Fernandez-Bonetti P, Lupi-Herrera E, Martinez-Guerra ML, Barrios R, Seoane M, Sandoval J. Peripheral airways obstruction in idiopathic pulmonary artery hypertension (primary). Chest. 1983 May;83(5):732-8.

Laveneziana P, Garcia G, Joureau B, Nicolas-Jilwan F, Brahimi T, Laviolette L, Sitbon O, Simonneau G, Humbert M, Similowski T. Dynamic respiratory mechanics and exertional dyspnoea in pulmonary arterial hypertension. Eur Respir J. 2013 Mar;41(3):578-87. doi: 10.1183/09031936.00223611. Epub 2012 Jul 12.

Spiekerkoetter E, Fabel H, Hoeper MM. Effects of inhaled salbutamol in primary pulmonary hypertension. Eur Respir J. 2002 Sep;20(3):524-8.

Starting date: June 2014
Last updated: June 23, 2015

Page last updated: August 23, 2015

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