Pulmonary Disease, Chronic Obstructive (COPD)NCT03269721
COPD-Related Physiology and the Brain
An observational study of Pulmonary Disease, Chronic Obstructive (COPD) and Cognitive Impairment, run by Karin Hoth at 1 site in United States.
Trial summary
COPD is the third leading cause of combined morbidity, disability, and mortality in the United States and is often associated with cognitive impairment. The goal of the proposed project is to examine novel pulmonary and vascular physiological mechanisms that contribute to structural brain abnormalities and cognitive… Read more about this study
- Who is it for?
- Ages 30 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive (COPD), Cognitive Impairment
- What is being tested?
- Neuropsychological Assessment, Spirometry and Arterial Blood Gas
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2017to 30 Apr 2025
- 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 30 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be recruited from the Iowa COPD research registry, which includes participants from several NIH funded studies with quantitative lung imaging obtained in the Iowa Comprehensive Lung Imaging Center.
Who may be able to join
- Age 30-85, > 8th grade education, Normal/corrected hearing and vision, English Speaker, Ability to comfortably lie flat for 1 hour.
Who cannot join
- Other concomitant respiratory disorder other than asthma (e.g., cystic fibrosis), 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, Eye surgery in the last 3 months, Pulmonary Hypertension, Insulin-dependent diabetes, Inability to use albuterol, 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, Prior neurological condition (e.g., stroke, epilepsy, head injury with >15 mins. loss of consciousness), Previous diagnosis of dementia or learning disability, Major comorbid medical conditions with known cognitive effects (e.g., renal failure, HF), Psychotic disorder, bipolar disorder, current substance use disorder other than tobacco use, Change in psychiatric medication in last month, Claustrophobia, Metal object in body that may interfere with neuroimaging.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determinants of Altered Brain Structure and Function in Smokers With COPD-Related Lung Pathophysiology
COPD is the third leading cause of combined morbidity, disability, and mortality in the United States and is often associated with cognitive impairment. The goal of the proposed project is to examine novel pulmonary and vascular physiological mechanisms that contribute to structural brain abnormalities and cognitive dysfunction early in the course of COPD. The project will generate information to ultimately inform the development of interventions to delay or prevent cognitive dysfunction.
Read the detailed description
Chronic Obstructive Pulmonary Disease (COPD) is the 3rd leading cause of morbidity and mortality in the US with increasing prevalence in older adults. The impact of COPD on the brain is an area of expanding research interest. A staggering 40-60% of patients with COPD have cognitive impairments including deficits in executive functioning (e.g., decision making), processing speed, and memory. Intact cognition is critical for independently managing daily tasks (e.g., medication and money management). Since there are currently no treatments to fully reverse cognitive impairment once it is present, preventing and delaying onset is essential. Given the high prevalence of COPD, understanding how COPD confers an increased risk for cognitive impairment should be a top public health priority. There is an urgent need to identify potentially modifiable physiological characteristics of individuals with early COPD-related pathophysiology who are at risk of developing brain abnormalities. The earliest changes that occur in COPD are driven by an enhanced chronic inflammatory response that includes small airway disease in the lung and vascular abnormalities. COPD-related lung pathophysiology can be measured continuously and is separable from amount of smoking. These physiological changes are often present in individuals who do not meet traditional criteria for COPD diagnosis and have not yet manifested significant clinical symptoms. We propose that chronic smokers who are susceptible to COPD and show evidence of COPD-related lung pathophysiology on lung CT also experience vascular dysfunction (particularly central artery stiffness) that contributes to structural brain abnormalities and cognitive impairment. The proposed project will: 1) model the effects of novel physiological mechanisms on the brain in COPD, 2) focus on changes in brain structure and function early in the development of COPD by including smokers who have evidence of early COPD-related lung pathophysiology but do not meet traditional criteria for COPD, and 3) utilize advanced technology to assess the lung (lung CT) and brain (MRI). We will recruit participants with existing lung CT from ongoing NIH projects to complete pulmonary and vascular measures, cognitive assessment, and brain MRI. The project is highly multidisciplinary and leverages unique resources at the University of Iowa including the Institute for Clinical and Translational Science, the Translational Human Vascular Physiology Lab, the Iowa Neuroimaging Consortium, and the Iowa Comprehensive Lung Imaging Center.
- Being tested
- Neuropsychological Assessment, Spirometry, Arterial Blood Gas, Diffusion Capacity of the Lung for Carbon Monoxide, 6 Minute Walk Test
- Keywords
- Cognition, Pulmonary, COPD, Lung
- Medical subject headings
- Lung Diseases, Pulmonary Disease, Chronic Obstructive, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological AssessmentBehavioural
Assessments include: Paper and pencil computerized measures of Memory, Language, Visuospatial Function, Executive Functioning-Processing Speed, and Attention
SpirometryProcedure or surgery
Pre and post bronchodilator spirometry will be administered according to the American Thoracic Society (ATS) guidelines.
Arterial Blood GasProcedure or surgery
Radial artery blood sample will be collected to measure gas exchange hemoglobin; arterial oxygen and carbon dioxide will be examined as potential covariates.
Diffusion Capacity of the Lung for Carbon MonoxideProcedure or surgery
Also called (DLCO)
For measurement of gas exchange in the lung. DLCO adjusted for hemoglobin will be the primary variable of interest and will be examined as a potential covariate.
6 Minute Walk TestDiagnostic test
Also called 6MWT
Distance walked in 6 minutes will be the primary outcome.
Systemic Vascular MeasuresProcedure or surgery
Carotid artery ultrasound, pulse wave velocity, brachial artery endothelium-dependent flow mediated dilation and endothelium-independent dilation will be measured.
Blood BiomarkersBiological
High sensitivity C-reactive protein (hs-CRP), and fibrinogen will be used as indicators of systemic inflammation, complete blood count with differential (CBC with diff) will be obtained to rule out acute infection as a cause of inflammation.
Symptom Questionnaire MeasuresBehavioural
M.I.N.I Screen 7.0.0, Beck Depression Inventory-II (DBI-II), State Trait Anxiety Inventory (STAI), COPD Assessment Test (CAT), St. George's Respiratory Questionnaire (SGRQ), MMRC Dyspnea Scale (MMRC), Berlin Questionnaire
Brain MRIProcedure or surgery
Primary neuroimaging outcomes of interest are white matter structural integrity
| Study group | Role | What they receive |
|---|---|---|
| Never Smoker | Neuropsychological Assessment, Spirometry, Arterial Blood Gas, Diffusion Capacity of the Lung for Carbon Monoxide, 6 Minute Walk test, Systemic Vascular Measures, Blood Biomarkers, Symptom Questionnaire Measures, Brain MRI Receives: Behavioral: Neuropsychological Assessment; Procedure: Spirometry; Procedure: Arterial Blood Gas; Procedure: Diffusion Capacity of the Lung for Carbon Monoxide; Diagnostic Test: 6 Minute Walk Test; Procedure: Systemic Vascular Measures; Biological: Blood Biomarkers; Behavioral: Symptom Questionnaire Measures; Procedure: Brain MRI | |
| Smoker/Past smoker-No Airflow Limitation | Neuropsychological Assessment, Spirometry, Arterial Blood Gas, Diffusion Capacity of the Lung for Carbon Monoxide, 6 Minute Walk test, Systemic Vascular Measures, Blood Biomarkers, Symptom Questionnaire Measures, Brain MRI Receives: Behavioral: Neuropsychological Assessment; Procedure: Spirometry; Procedure: Arterial Blood Gas; Procedure: Diffusion Capacity of the Lung for Carbon Monoxide; Diagnostic Test: 6 Minute Walk Test; Procedure: Systemic Vascular Measures; Biological: Blood Biomarkers; Behavioral: Symptom Questionnaire Measures; Procedure: Brain MRI | |
| Smoker/Past smoker-W/Airflow Limitation | Neuropsychological Assessment, Spirometry, Arterial Blood Gas, Diffusion Capacity of the Lung for Carbon Monoxide, 6 Minute Walk test, Systemic Vascular Measures, Blood Biomarkers, Symptom Questionnaire Measures, Brain MRI Receives: Behavioral: Neuropsychological Assessment; Procedure: Spirometry; Procedure: Arterial Blood Gas; Procedure: Diffusion Capacity of the Lung for Carbon Monoxide; Diagnostic Test: 6 Minute Walk Test; Procedure: Systemic Vascular Measures; Biological: Blood Biomarkers; Behavioral: Symptom Questionnaire Measures; Procedure: Brain MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
White matter (WM) structural integrity from brain magnetic resonance imaging (MRI)
Fractional anisotropy from diffusion weighted imaging will be the primary WM measure
Measured: At the end of data collection in 2024
Neuropsychological test performance: average executive functioning-processing speed domain summary score
The domain summary score represents the average of the norm referenced standardized scores for the following measures: Trail Making Test Part B, Controlled Oral Word Association, Stroop Color Word Test Interference Score, and WAIS-IV (Wechsler Adult Intelligence Scale IV) Coding
Measured: At the end of data collection in 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study start1 May 2017
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic Obstructive (COPD)Studies 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
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karin Hoth
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)
- Responsible party
- Sponsor-investigator, Karin Hoth, University of Iowa
- Investigators
- Karin F Hoth, PhD, Principal investigator, University of Iowa Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03269721
- Sponsor's protocol ID
- 201404738
- Other IDs
- 1R01HL134822-01
- Status last verified
- Dec 2025
- First submitted
- 30 Aug 2017
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants of Altered Brain Structure and Function in Smokers With COPD-Related Lung Pathophysiology
- ClinicalTrials.gov ID
- NCT03269721
- Acronym / sponsor ID
- 201404738
- Keywords
- Cognition, Pulmonary, COPD, Lung
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Karin HothUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)
- Study start
- 1 May 2017 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 1 Sep 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.
COPD is the third leading cause of combined morbidity, disability, and mortality in the United States and is often associated with cognitive impairment. The goal of the proposed project is to examine novel pulmonary and vascular physiological mechanisms that contribute to structural brain abnormalities and cognitive dysfunction early in the course of COPD. The project will generate information to ultimately inform the development of interventions to delay or prevent cognitive dysfunction.
Detailed description
Chronic Obstructive Pulmonary Disease (COPD) is the 3rd leading cause of morbidity and mortality in the US with increasing prevalence in older adults. The impact of COPD on the brain is an area of expanding research interest. A staggering 40-60% of patients with COPD have cognitive impairments including deficits in executive functioning (e.g., decision making), processing speed, and memory. Intact cognition is critical for independently managing daily tasks (e.g., medication and money management). Since there are currently no treatments to fully reverse cognitive impairment once it is present, preventing and delaying onset is essential. Given the high prevalence of COPD, understanding how COPD confers an increased risk for cognitive impairment should be a top public health priority. There is an urgent need to identify potentially modifiable physiological characteristics of individuals with early COPD-related pathophysiology who are at risk of developing brain abnormalities. The earliest changes that occur in COPD are driven by an enhanced chronic inflammatory response that includes small airway disease in the lung and vascular abnormalities. COPD-related lung pathophysiology can be measured continuously and is separable from amount of smoking. These physiological changes are often present in individuals who do not meet traditional criteria for COPD diagnosis and have not yet manifested significant clinical symptoms. We propose that chronic smokers who are susceptible to COPD and show evidence of COPD-related lung pathophysiology on lung CT also experience vascular dysfunction (particularly central artery stiffness) that contributes to structural brain abnormalities and cognitive impairment. The proposed project will: 1) model the effects of novel physiological mechanisms on the brain in COPD, 2) focus on changes in brain structure and function early in the development of COPD by including smokers who have evidence of early COPD-related lung pathophysiology but do not meet traditional criteria for COPD, and 3) utilize advanced technology to assess the lung (lung CT) and brain (MRI). We will recruit participants with existing lung CT from ongoing NIH projects to complete pulmonary and vascular measures, cognitive assessment, and brain MRI. The project is highly multidisciplinary and leverages unique resources at the University of Iowa including the Institute for Clinical and Translational Science, the Translational Human Vascular Physiology Lab, the Iowa Neuroimaging Consortium, and the Iowa Comprehensive Lung Imaging Center.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Never Smoker | – | Behavioral: Neuropsychological Assessment, Procedure: Spirometry, Procedure: Arterial Blood Gas, Procedure: Diffusion Capacity of the Lung for Carbon Monoxide, Diagnostic Test: 6 Minute Walk Test, Procedure: Systemic Vascular Measures, Biological: Blood Biomarkers, Behavioral: Symptom Questionnaire Measures, Procedure: Brain MRINeuropsychological Assessment, Spirometry, Arterial Blood Gas, Diffusion Capacity of the Lung for Carbon Monoxide, 6 Minute Walk test, Systemic Vascular Measures, Blood Biomarkers, Symptom Questionnaire Measures, Brain MRI |
| Smoker/Past smoker-No Airflow Limitation | – | Behavioral: Neuropsychological Assessment, Procedure: Spirometry, Procedure: Arterial Blood Gas, Procedure: Diffusion Capacity of the Lung for Carbon Monoxide, Diagnostic Test: 6 Minute Walk Test, Procedure: Systemic Vascular Measures, Biological: Blood Biomarkers, Behavioral: Symptom Questionnaire Measures, Procedure: Brain MRINeuropsychological Assessment, Spirometry, Arterial Blood Gas, Diffusion Capacity of the Lung for Carbon Monoxide, 6 Minute Walk test, Systemic Vascular Measures, Blood Biomarkers, Symptom Questionnaire Measures, Brain MRI |
| Smoker/Past smoker-W/Airflow Limitation | – | Behavioral: Neuropsychological Assessment, Procedure: Spirometry, Procedure: Arterial Blood Gas, Procedure: Diffusion Capacity of the Lung for Carbon Monoxide, Diagnostic Test: 6 Minute Walk Test, Procedure: Systemic Vascular Measures, Biological: Blood Biomarkers, Behavioral: Symptom Questionnaire Measures, Procedure: Brain MRINeuropsychological Assessment, Spirometry, Arterial Blood Gas, Diffusion Capacity of the Lung for Carbon Monoxide, 6 Minute Walk test, Systemic Vascular Measures, Blood Biomarkers, Symptom Questionnaire Measures, Brain MRI |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from the Iowa COPD research registry, which includes participants from several NIH funded studies with quantitative lung imaging obtained in the Iowa Comprehensive Lung Imaging Center.
Key inclusion criteria (1 listed)
- Age 30-85, > 8th grade education, Normal/corrected hearing and vision, English Speaker, Ability to comfortably lie flat for 1 hour.
Key exclusion criteria (1 listed)
- Other concomitant respiratory disorder other than asthma (e.g., cystic fibrosis), 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, Eye surgery in the last 3 months, Pulmonary Hypertension, Insulin-dependent diabetes, Inability to use albuterol, 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, Prior neurological condition (e.g., stroke, epilepsy, head injury with >15 mins. loss of consciousness), Previous diagnosis of dementia or learning disability, Major comorbid medical conditions with known cognitive effects (e.g., renal failure, HF), Psychotic disorder, bipolar disorder, current substance use disorder other than tobacco use, Change in psychiatric medication in last month, Claustrophobia, Metal object in body that may interfere with neuroimaging.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuropsychological AssessmentAssessments include: Paper and pencil computerized measures of Memory, Language, Visuospatial Function, Executive Functioning-Processing Speed, and Attention | Behavioural | Never Smoker, Smoker/Past smoker-No Airflow Limitation, Smoker/Past smoker-W/Airflow Limitation |
| SpirometryPre and post bronchodilator spirometry will be administered according to the American Thoracic Society (ATS) guidelines. | Procedure or surgery | Never Smoker, Smoker/Past smoker-No Airflow Limitation, Smoker/Past smoker-W/Airflow Limitation |
| Arterial Blood GasRadial artery blood sample will be collected to measure gas exchange hemoglobin; arterial oxygen and carbon dioxide will be examined as potential covariates. | Procedure or surgery | Never Smoker, Smoker/Past smoker-No Airflow Limitation, Smoker/Past smoker-W/Airflow Limitation |
| Diffusion Capacity of the Lung for Carbon MonoxideAlso: (DLCO)For measurement of gas exchange in the lung. DLCO adjusted for hemoglobin will be the primary variable of interest and will be examined as a potential covariate. | Procedure or surgery | Never Smoker, Smoker/Past smoker-No Airflow Limitation, Smoker/Past smoker-W/Airflow Limitation |
| 6 Minute Walk TestAlso: 6MWTDistance walked in 6 minutes will be the primary outcome. | Diagnostic test | Never Smoker, Smoker/Past smoker-No Airflow Limitation, Smoker/Past smoker-W/Airflow Limitation |
| Systemic Vascular MeasuresCarotid artery ultrasound, pulse wave velocity, brachial artery endothelium-dependent flow mediated dilation and endothelium-independent dilation will be measured. | Procedure or surgery | Never Smoker, Smoker/Past smoker-No Airflow Limitation, Smoker/Past smoker-W/Airflow Limitation |
| Blood BiomarkersHigh sensitivity C-reactive protein (hs-CRP), and fibrinogen will be used as indicators of systemic inflammation, complete blood count with differential (CBC with diff) will be obtained to rule out acute infection as a cause of inflammation. | Biological | Never Smoker, Smoker/Past smoker-No Airflow Limitation, Smoker/Past smoker-W/Airflow Limitation |
| Symptom Questionnaire MeasuresM.I.N.I Screen 7.0.0, Beck Depression Inventory-II (DBI-II), State Trait Anxiety Inventory (STAI), COPD Assessment Test (CAT), St. George's Respiratory Questionnaire (SGRQ), MMRC Dyspnea Scale (MMRC), Berlin Questionnaire | Behavioural | Never Smoker, Smoker/Past smoker-No Airflow Limitation, Smoker/Past smoker-W/Airflow Limitation |
| Brain MRIPrimary neuroimaging outcomes of interest are white matter structural integrity | Procedure or surgery | Never Smoker, Smoker/Past smoker-No Airflow Limitation, Smoker/Past smoker-W/Airflow Limitation |
Primary outcome
White matter (WM) structural integrity from brain magnetic resonance imaging (MRI)
Time frame: At the end of data collection in 2024
Fractional anisotropy from diffusion weighted imaging will be the primary WM measure
Neuropsychological test performance: average executive functioning-processing speed domain summary score
Time frame: At the end of data collection in 2024
The domain summary score represents the average of the norm referenced standardized scores for the following measures: Trail Making Test Part B, Controlled Oral Word Association, Stroop Color Word Test Interference Score, and WAIS-IV (Wechsler Adult Intelligence Scale IV) Coding
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 24 Dec 2025.
- 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.
Karin F Hoth, PhD principal investigator
University of Iowa Department of Psychiatry
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 Pulmonary Disease, Chronic Obstructive (COPD) and Cognitive Impairment, run by Karin Hoth 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 1 inclusion and 1 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 24 Dec 2025. 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?
White matter (WM) structural integrity from brain magnetic resonance imaging (MRI) (time frame: At the end of data collection in 2024). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Dec 2025.