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Albuterol and Dynamic Hyperinflation in Idiopathic Pulmonary Arterial Hypertension

Primary Purpose

Idiopathic Pulmonary Arterial Hypertension.

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Albuterol.
Normal saline placebo
Sponsored by
American Medical Association Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Pulmonary Arterial Hypertension.

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • LSUHSC Interim Louisiana Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Albuterol

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 7, 2014
Last Updated
December 29, 2015
Sponsor
American Medical Association Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02108743
Brief Title
Albuterol and Dynamic Hyperinflation in Idiopathic Pulmonary Arterial Hypertension
Official Title
Albuterol and Dynamic Hyperinflation in Idiopathic Pulmonary Arterial Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of funding
Study Start Date
June 2014 (undefined)
Primary Completion Date
July 2016 (Anticipated)
Study Completion Date
October 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
American Medical Association Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Arterial Hypertension.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Albuterol
Arm Type
Active Comparator
Arm Description
2.5 mg of albuterol inhaled via jet nebulizer 15 minutes prior to symptom-limited maximal CPET.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Normal saline placebo inhaled via jet nebulizer 15 minutes prior to symptom-limited maximal CPET.
Intervention Type
Drug
Intervention Name(s)
Albuterol.
Intervention Description
2.5 mg of albuterol inhaled via jet nebulizer 15 minutes prior to symptom-limited maximal CPET.
Intervention Type
Drug
Intervention Name(s)
Normal saline placebo
Intervention Description
Placebo inhaled via jet nebulizer 15 minutes prior to symptom-limited maximal CPET.
Primary Outcome Measure Information:
Title
End-expiratory lung volume:total lung capacity (EELV/TLC) ratio at matched metabolic isowork.
Description
Determined by measuring inspiratory capacity every 2 minutes during cardiopulmonary exercise test (CPET)
Time Frame
up to 3 days
Secondary Outcome Measure Information:
Title
Change in peak oxygen consumption with albuterol
Description
Measured at the end of CPET
Time Frame
Study days 2 and 3
Title
Change in O2 pulse with albuterol.
Description
Measured throughout CPET and compared at matched metabolic isotimes
Time Frame
Study days 2 and 3
Title
Exercise time
Description
Total ramped exercise time
Time Frame
Study days 2 and 3
Title
Borg dyspnea score
Description
Measured every 2 minutes throughout CPET
Time Frame
Days 2 and 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Lammi, MD
Organizational Affiliation
Louisiana State University Health Sciences Center in New Orleans
Official's Role
Principal Investigator
Facility Information:
Facility Name
LSUHSC Interim Louisiana Hospital
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12037220
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.
Results Reference
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PubMed Identifier
6839814
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.
Results Reference
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PubMed Identifier
22790921
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.
Results Reference
background
PubMed Identifier
12358324
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.
Results Reference
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Albuterol and Dynamic Hyperinflation in Idiopathic Pulmonary Arterial Hypertension

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