NCT03235297

Brief Summary

The purpose of this study is to further understand the effects of altitude on the physiology of gas exchange in the pulmonary microcirculation in normal subjects and in people with chronic obstructive pulmonary disease (COPD) measured as the single-breath diffusing capacity for carbon monoxide (DLCOsb). The study will determine a mathematical formula to allow for altitude corrections in both study populations to be used clinically in pulmonary labs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
completed

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

July 28, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 1, 2017

Completed
9 days until next milestone

Study Start

First participant enrolled

August 10, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

February 12, 2020

Status Verified

February 1, 2020

Enrollment Period

10 months

First QC Date

July 28, 2017

Last Update Submit

February 11, 2020

Conditions

Keywords

AltitudeDiffusing capacity for carbon monoxideCOPDPulmonary function testing

Outcome Measures

Primary Outcomes (1)

  • Effect of altitude on measured diffusing capacity for carbon monoxide

    3 weeks

Secondary Outcomes (1)

  • Comparison of a novel inert gas technique for measuring alveolar volume with body plethysmography

    4 months

Study Arms (2)

Healthy subjects

Healthy subjects

Subjects with COPD

Subjects with a diagnosis of COPD

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Men and women, ages 20-80, both healthy subjects and those with a diagnosis of COPD.

You may qualify if:

  • Ages 20- 80 years
  • Subjects must be either healthy or have been diagnosed with COPD

You may not qualify if:

  • Anemia (hemoglobin \< 10.0 g/dL)
  • Carboxyhemoglobin \> 3%
  • Active smoking
  • Heart disease or heart failure
  • Pulmonary hypertension
  • COPD exacerbation
  • Pneumothroax within 6 months
  • Bullous emphysema on chest imaging (Chest X-ray or CT)
  • Supplemental oxygen use
  • Diabetes mellitus
  • Alcohol dependence
  • Non-English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Intermountain Medical Center

Murray, Utah, 84157, United States

Location

Related Publications (1)

  • Hegewald MJ, DeCato TW, Weaver LK, Jensen RL. Effect of barometric pressure on single-breath carbon monoxide diffusing capacity. Respir Physiol Neurobiol. 2023 Feb;308:103997. doi: 10.1016/j.resp.2022.103997. Epub 2022 Nov 17.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Matt Hegewald, MD

    Intermountain Health Care, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct Associate Professor, University of Utah

Study Record Dates

First Submitted

July 28, 2017

First Posted

August 1, 2017

Study Start

August 10, 2017

Primary Completion

June 15, 2018

Study Completion

July 1, 2019

Last Updated

February 12, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations