COPDDLCONCT03235297
Effects of Altitude on Single-Breath Diffusing Capacity for Carbon Monoxide
An observational study of COPD, run by Intermountain Health Care, Inc. at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- COPD
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Aug 2017to 1 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Adult, Older adult
Study population: Men and women, ages 20-80, both healthy subjects and those with a diagnosis of COPD.
Who may be able to join
- Ages 20- 80 years
- Subjects must be either healthy or have been diagnosed with COPD
Who cannot join
- Anemia (hemoglobin < 10.0 g/dL)
- Carboxyhemoglobin > 3%
- Active smoking
- Heart disease or heart failure
- Pulmonary hypertension
- COPD exacerbation
Show all 12Show fewer
- Pneumothroax within 6 months
- Bullous emphysema on chest imaging (Chest X-ray or CT)
- Supplemental oxygen use
- Diabetes mellitus
- Alcohol dependence
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Altitude on Single-Breath Diffusing Capacity for Carbon Monoxide in Normal Subjects and Chronic Obstructive Pulmonary Disease
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.
Read the detailed description
The DLCOsb is one of the most common and widely tests clinically used across the world in pulmonary function laboratories to assess gas exchange from the lung to hemoglobin in the pulmonary circulation. This test is used in the differential diagnosis of respiratory related symptoms, to grade the degree of severity in lung disease, and to objectively monitor the progression of disease or the response to therapies. Therefore, it is important to have standard methods of performing and interpreting this test.This is a prospective study, collecting data from subjects at different simulated altitudes. The study hypothesis is that increasing altitude will increase the DLCOsb in a predictable manner that will allow for mathematical corrections to be applied for uniform interpretation in pulmonary labs at differing altitudes.
- Conditions
- COPD
- Keywords
- Altitude, Diffusing capacity for carbon monoxide, COPD, Pulmonary function testing
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Healthy subjects | |
| Subjects with COPD | Subjects with a diagnosis of COPD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of altitude on measured diffusing capacity for carbon monoxide
Measured: 3 weeks
Secondary outcomes (1)
Comparison of a novel inert gas technique for measuring alveolar volume with body plethysmography
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2017
- Study start10 Aug 2017
- Primary completion15 Jun 2018
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- University of Utah
- Responsible party
- Principal investigator, Matthew Hegewald, Intermountain Health Care, Inc.
- Investigators
- Matt Hegewald, MD, Principal investigator, Intermountain Health Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03235297
- Sponsor's protocol ID
- DLCO
- Acronym
- DLCO
- Status last verified
- Feb 2020
- First submitted
- 28 Jul 2017
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36402362
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Altitude on Single-Breath Diffusing Capacity for Carbon Monoxide in Normal Subjects and Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT03235297
- Acronym / sponsor ID
- DLCO / DLCO
- Conditions
- COPD
- Keywords
- Altitude, Diffusing capacity for carbon monoxide, COPD, Pulmonary function testing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Collaborators
- University of Utah
- Study start
- 10 Aug 2017 (actual)
- Primary completion
- 15 Jun 2018 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 1 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The DLCOsb is one of the most common and widely tests clinically used across the world in pulmonary function laboratories to assess gas exchange from the lung to hemoglobin in the pulmonary circulation. This test is used in the differential diagnosis of respiratory related symptoms, to grade the degree of severity in lung disease, and to objectively monitor the progression of disease or the response to therapies. Therefore, it is important to have standard methods of performing and interpreting this test.This is a prospective study, collecting data from subjects at different simulated altitudes. The study hypothesis is that increasing altitude will increase the DLCOsb in a predictable manner that will allow for mathematical corrections to be applied for uniform interpretation in pulmonary labs at differing altitudes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | – | –Healthy subjects |
| Subjects with COPD | – | –Subjects with a diagnosis of COPD |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Men and women, ages 20-80, both healthy subjects and those with a diagnosis of COPD.
Key inclusion criteria (2 listed)
- Ages 20- 80 years
- Subjects must be either healthy or have been diagnosed with COPD
Key exclusion criteria (12 listed)
- Anemia (hemoglobin < 10.0 g/dL)
- Carboxyhemoglobin > 3%
- Active smoking
- Heart disease or heart failure
- Pulmonary hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Effect of altitude on measured diffusing capacity for carbon monoxide
Time frame: 3 weeks
1 secondary outcome
Comparison of a novel inert gas technique for measuring alveolar volume with body plethysmography
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
- Derived from this study: PubMed 36402362Hegewald 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matt Hegewald, MD principal investigator
Intermountain Health Care, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD, run by Intermountain Health Care, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of altitude on measured diffusing capacity for carbon monoxide (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03235297, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2020.