MedDataX Logo

Albuterol and Dynamic Hyperinflation in Idiopathic Pulmonary Arterial Hypertension

NCT ID: NCT02108743

Last Updated: 2015-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2016-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Idiopathic Pulmonary Arterial Hypertension.

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Albuterol

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

Group Type ACTIVE_COMPARATOR

Albuterol.

Intervention Type DRUG

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Normal saline placebo

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Albuterol.

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

Intervention Type DRUG

Normal saline placebo

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

American Medical Association Foundation

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Matthew Lammi

Assistant Professor of Medicine, Section of Pulmonary and Critical Care

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Matthew Lammi, MD

Role: PRINCIPAL_INVESTIGATOR

Louisiana State University Health Sciences Center in New Orleans

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

LSUHSC Interim Louisiana Hospital

New Orleans, Louisiana, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 12037220 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 6839814 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22790921 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12358324 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB8603

Identifier Type: -

Identifier Source: org_study_id