Albuterol and Dynamic Hyperinflation in Idiopathic Pulmonary Arterial Hypertension

Idiopathic Pulmonary Arterial Hypertension. Clinical Trial

Official title:

Albuterol and Dynamic Hyperinflation in Idiopathic Pulmonary Arterial Hypertension

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02108743
• Other study ID #: IRB8603
• Status: Withdrawn
• Phase: Phase 2
• First received: April 7, 2014
• Last updated: December 29, 2015
• Start date: June 2014
• Est. completion date: October 2016

Study information

• Verified date: December 2015
• Source: American Medical Association Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Idiopathic Pulmonary Arterial Hypertension.

Intervention

Drug:
• Albuterol.
2.5 mg of albuterol inhaled via jet nebulizer 15 minutes prior to symptom-limited maximal CPET.
• Normal saline placebo
Placebo inhaled via jet nebulizer 15 minutes prior to symptom-limited maximal CPET.

Locations

Country	Name	City	State
United States	LSUHSC Interim Louisiana Hospital	New Orleans	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
American Medical Association Foundation

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View Citation

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. — View Citation

Spiekerkoetter E, Fabel H, Hoeper MM. Effects of inhaled salbutamol in primary pulmonary hypertension. Eur Respir J. 2002 Sep;20(3):524-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change in peak oxygen consumption with albuterol	Measured at the end of CPET	Study days 2 and 3	No
Secondary	Change in O2 pulse with albuterol.	Measured throughout CPET and compared at matched metabolic isotimes	Study days 2 and 3	No
Secondary	Exercise time	Total ramped exercise time	Study days 2 and 3	No
Secondary	Borg dyspnea score	Measured every 2 minutes throughout CPET	Days 2 and 3	No