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

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ClinicalTrials.gov Identifier: NCT03611699
Recruitment Status : Recruiting
First Posted : August 2, 2018
Last Update Posted : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
Gary L. Pierce, University of Iowa

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.

Condition or disease Intervention/treatment Phase
COPD Drug: Umeclidinium / Vilanterol Dry Powder Inhaler Drug: Placebo Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Masking Description: Double-blind masking. Participant and Investigators will not know if the participants has received a long-acting bronchodilator or a placebo inhaler.
Primary Purpose: Basic Science
Official Title: Static Lung Hyperinflation and Sympathetic Nerve Activity-Associated Large Artery Stiffness in COPD Patients
Actual Study Start Date : January 24, 2019
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Umeclidinium bromide/vilanterol
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
umeclidinium/vilanterol dry powder inhaler
Other Name: Anora Ellipta

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




Primary Outcome Measures :
  1. Carotid artery stiffness [ Time Frame: 2 hours ]
    Carotid artery stiffness as determined by carotid sonography

  2. Aortic stiffness [ Time Frame: 2 hours ]
    Aortic stiffness as determined by the carotid-femoral pulse wave velocity technique



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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  • Heart failure
  • Substance use disorder
  • Cystic fibrosis
  • Glaucoma
  • Prostate disorder
  • Allergy to milk or milk products
  • Cardiac arrhythmia
  • Currently using a LAMA/LABA combination bronchodilator

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): NCT03611699


Contacts
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Contact: Gary L Pierce, PhD 319-335-9487 gary-pierce@uiowa.edu
Contact: Rachel E Luehrs, MS 319-467-0294 rachel-luehrs@uiowa.edu

Locations
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United States, Iowa
The University of Iowa Hospital and Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Gary L Pierce, PhD    319-335-9487    gary-pierce@uiowa.du   
Contact: Rachel E Luehrs, MS    319-467-0294    rachel-luehrs@uiowa.edu   
Sponsors and Collaborators
Gary L. Pierce
Investigators
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Principal Investigator: Gary L Pierce, PhD University of Iowa

Publications:

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Responsible Party: Gary L. Pierce, Associate Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT03611699     History of Changes
Other Study ID Numbers: 201805782
First Posted: August 2, 2018    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Bromides
Anticonvulsants