Clinical trial NCT02108743: Albuterol and Dynamic Hyperinflation in Idiopathic Pulmonary Arterial Hypertension
Official title: Albuterol and Dynamic Hyperinflation in Idiopathic Pulmonary Arterial Hypertension
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Idiopathic Pulmonary Arterial Hypertension.
Lead sponsor: American Medical Association Foundation
Sponsor class: OTHER
First posted: 2014-04-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: End-expiratory lung volume:total lung capacity (EELV/TLC) ratio at matched metabolic isowork.
timeFrame: up to 3 days
Secondary outcomes:
measure: Change in peak oxygen consumption with albuterol
timeFrame: Study days 2 and 3
measure: Change in O2 pulse with albuterol.
timeFrame: Study days 2 and 3
measure: Exercise time
timeFrame: Study days 2 and 3
measure: Borg dyspnea score
timeFrame: Days 2 and 3
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: LSUHSC Interim Louisiana Hospital
state: Louisiana
Study officials:
affiliation: Louisiana State University Health Sciences Center in New Orleans
name: Matthew Lammi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Meyer FJ, Ewert R, Hoeper MM, Olschewski H, Behr J, Winkler J, Wilkens H, Breuer C, Kubler W, Borst MM; German PPH Study Group. Peripheral airway obstruction in primary pulmonary hypertension. Thorax. 2002 Jun;57(6):473-6. doi: 10.1136/thorax.57.6.473.
citation: 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. doi: 10.1378/chest.83.5.732.
citation: 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.
citation: Spiekerkoetter E, Fabel H, Hoeper MM. Effects of inhaled salbutamol in primary pulmonary hypertension. Eur Respir J. 2002 Sep;20(3):524-8. doi: 10.1183/09031936.02.02572001.