NCT02108743

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 9, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

December 30, 2015

Status Verified

December 1, 2015

Enrollment Period

2.1 years

First QC Date

April 7, 2014

Last Update Submit

December 29, 2015

Conditions

Idiopathic Pulmonary Arterial Hypertension.

Outcome Measures

Primary Outcomes (1)

  • 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)

    up to 3 days

Secondary Outcomes (4)

  • Change in peak oxygen consumption with albuterol

    Study days 2 and 3

  • Change in O2 pulse with albuterol.

    Study days 2 and 3

  • Exercise time

    Study days 2 and 3

  • Borg dyspnea score

    Days 2 and 3

Study Arms (2)

Albuterol

ACTIVE COMPARATOR

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

Drug: Albuterol.

Placebo

PLACEBO COMPARATOR

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

Drug: Normal saline placebo

Interventions

Albuterol.DRUG

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

Albuterol
Normal saline placeboDRUG

Placebo inhaled via jet nebulizer 15 minutes prior to symptom-limited maximal CPET.

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or greater.
  • Idiopathic Pulmonary Arterial Hypertension, or Familial Pulmonary Arterial Hypertension.
  • Forced expiratory flow 75% (FEF75%) of ≤ 65% of predicted.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LSUHSC Interim Louisiana Hospital

New Orleans, Louisiana, 70112, United States

Location

Related Publications (4)

  • 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.

    PMID: 12037220BACKGROUND

  • 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.

    PMID: 6839814BACKGROUND

  • 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.

    PMID: 22790921BACKGROUND

  • 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.

    PMID: 12358324BACKGROUND

MeSH Terms

Conditions

Familial Primary Pulmonary Hypertension

Interventions

Albuterol

Condition Hierarchy (Ancestors)

Hypertension, PulmonaryLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPhenethylaminesEthylamines

Study Officials

  • Matthew Lammi, MD

    Louisiana State University Health Sciences Center in New Orleans

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine, Section of Pulmonary and Critical Care

Study Record Dates

First Submitted

April 7, 2014

First Posted

April 9, 2014

Study Start

June 1, 2014

Primary Completion

July 1, 2016

Study Completion

October 1, 2016

Last Updated

December 30, 2015

Record last verified: 2015-12

Locations

US(1)