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Albuterol and Dynamic Hyperinflation in Idiopathic Pulmonary Arterial Hypertension

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ClinicalTrials.gov Identifier: NCT02108743
Recruitment Status : Withdrawn (Lack of funding)
First Posted : April 9, 2014
Last Update Posted : December 30, 2015
Sponsor:
Information provided by (Responsible Party):
Matthew Lammi, Louisiana State University Health Sciences Center in New Orleans

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.

Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Arterial Hypertension. Drug: Albuterol. Drug: Normal saline placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Albuterol and Dynamic Hyperinflation in Idiopathic Pulmonary Arterial Hypertension
Study Start Date : June 2014
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : October 2016


Arm Intervention/treatment
Active Comparator: Albuterol
2.5 mg of albuterol inhaled via jet nebulizer 15 minutes prior to symptom-limited maximal CPET.
Drug: Albuterol.
2.5 mg of albuterol inhaled via jet nebulizer 15 minutes prior to symptom-limited maximal CPET.

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




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


Secondary Outcome Measures :
  1. Change in peak oxygen consumption with albuterol [ Time Frame: Study days 2 and 3 ]
    Measured at the end of CPET

  2. Change in O2 pulse with albuterol. [ Time Frame: Study days 2 and 3 ]
    Measured throughout CPET and compared at matched metabolic isotimes

  3. Exercise time [ Time Frame: Study days 2 and 3 ]
    Total ramped exercise time

  4. Borg dyspnea score [ Time Frame: Days 2 and 3 ]
    Measured every 2 minutes throughout CPET



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02108743


Locations
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United States, Louisiana
LSUHSC Interim Louisiana Hospital
New Orleans, Louisiana, United States, 70112
Sponsors and Collaborators
American Medical Association Foundation
Investigators
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Principal Investigator: Matthew Lammi, MD Louisiana State University Health Sciences Center in New Orleans

Publications:
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Responsible Party: Matthew Lammi, Assistant Professor of Medicine, Section of Pulmonary and Critical Care, Louisiana State University Health Sciences Center in New Orleans
ClinicalTrials.gov Identifier: NCT02108743     History of Changes
Other Study ID Numbers: IRB8603
First Posted: April 9, 2014    Key Record Dates
Last Update Posted: December 30, 2015
Last Verified: December 2015

Additional relevant MeSH terms:
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Albuterol
Hypertension
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action