Static Lung Hyperinflation and Sympathetic Nerve Activity-Associated Large Artery Stiffness in COPD Patients

NCT03611699 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: 201805782
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to evaluate the acute effects of a long-acting bronchodilator on pulmonary function, vascular function and muscle sympathetic nerve activity in individuals with COPD. Individuals will be recruited from previous pulmonary research cohorts at The University of Iowa hospitals and clinics. Individuals that are interested in the study and are deemed eligible to participate will have a total of 3 visits to the laboratory, which includes the screening and consent (visit 1) that will last approximately 1 hour. Visits 2 and 3 are experimental visits and will be more extensive (\~4 hours). Participants will be randomized to receive either a long-acting bronchodilator or a placebo inhaler at the first experimental visit, followed by either the placebo inhaler or the long-acting bronchodilator at the second experimental visit. Assessments of pulmonary function, vascular function (via non-invasive, well-established techniques), and muscle sympathetic nerve activity will be performed at both experimental visits.

Conditions

COPD

Outcome Measures

Primary Outcomes (2)

• Carotid artery stiffness

  Carotid artery stiffness as determined by carotid sonography

  2 hours

• Aortic stiffness

  Aortic stiffness as determined by the carotid-femoral pulse wave velocity technique

  2 hours

Study Arms (2)

Umeclidinium bromide/vilanterol

ACTIVE COMPARATOR

Umeclidinium bromide/vilanterol (umeclidinium bromide 62.5 mcg; vilanterol 25mcg inhalation powder; trade name Anoro Ellipta) is a combination long-acting bronchodilator that acts to reduce the amount of air trapped in the lungs at the end of of expiration.

Drug: Umeclidinium / Vilanterol Dry Powder Inhaler

Placebo

PLACEBO COMPARATOR

A placebo inhaler will be administered to serve as a control comparator to the umeclidinium bromide/vilanterol inhaler.

Drug: Placebo

Interventions

Umeclidinium / Vilanterol Dry Powder Inhaler DRUG

umeclidinium/vilanterol dry powder inhaler

Also known as: Anora Ellipta

Umeclidinium bromide/vilanterol

Placebo DRUG

Placebo inhaler

Placebo

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 30-80
• Ability to comfortably lie flat for 2 hours
• Normal/corrected hearing and vision
• English speaking
• Airway predominate phenotype of COPD

You may not qualify if:

• Other concomitant respiratory disorder (including asthma)
• Use of antibiotics or steroids for a COPD exacerbation within the past month
• Use of 24-hour oxygen
• Pregnancy or suspected pregnancy
• Uncontrolled cancer within the last 5 years
• Radiation therapy to the chest
• Lung surgery (LVRS, transplant, lobectomy)
• Lung cancer known or suspected
• Insulin-dependent diabetes
• Inability to use an inhaler bronchodilator
• Eye surgery in the last 5 weeks
• Chest or abdominal surgery in the past 3 months
• Heart attack in the last 3 months
• Hospitalization for any heart problem in the past month
• Renal failure

Sponsors & Collaborators

• Gary L. Pierce: lead

Study Sites (1)

The University of Iowa Hospital and Clinics

Iowa City, Iowa, 52242, United States

Location

Related Publications (21)

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  PMID: 22029978 BACKGROUND

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  PMID: 24362752 BACKGROUND

• Macefield VG. Sustained activation of muscle sympathetic outflow during static lung inflation depends on a high intrathoracic pressure. J Auton Nerv Syst. 1998 Feb 5;68(3):135-9. doi: 10.1016/s0165-1838(97)00129-x.

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• Holwerda SW, Luehrs RE, Gremaud AL, Wooldridge NA, Stroud AK, Fiedorowicz JG, Abboud FM, Pierce GL. Relative burst amplitude of muscle sympathetic nerve activity is an indicator of altered sympathetic outflow in chronic anxiety. J Neurophysiol. 2018 Jul 1;120(1):11-22. doi: 10.1152/jn.00064.2018. Epub 2018 Mar 14.

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MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

GSK573719

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gary L Pierce, PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind masking. Participant and Investigators will not know if the participants has received a long-acting bronchodilator or a placebo inhaler.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 26, 2018
• First Posted: August 2, 2018
• Study Start: January 24, 2019
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: July 14, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)