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