Chronic Obstructive Pulmonary Disease (COPD)CAPTURENCT03581227
The CAPTURE Study: Validating a Unique COPD Case Finding Tool in Primary Care (Aim 1)
An observational study of Chronic Obstructive Pulmonary Disease (COPD), run by Weill Medical College of Cornell University at 8 sites in United States.
Trial summary
A prospective multi-center study to define the sensitivity and specificity of CAPTURE for identifying previously undiagnosed patients with clinically significant COPD in a broad range of primary care settings. Read more about this study
- Who is it for?
- Ages 45 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- CAPTURE Tool
- How many people
- 4,679 participants
- Where
- 8 sitesUnited States
- Study dates
- 12 Oct 2018to 1 Apr 2022
- 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 45 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult men and women recruited from a broad range of primary care settings across the United States.
Who may be able to join
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 45-80 years
Who cannot join
- Previous clinician provided diagnosis of COPD
- Treated respiratory infection (with antibiotics and/or systemic steroids) in the past 30 days of baseline
- Participants unable to perform spirometry due to any of the following conditions within the past 30 days of baseline
- Chest surgery
- Abdominal surgery
- Eye surgery
- Heart attack
- Stroke
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
High Plains Research Network
Aurora, Colorado, 80054
Atrium Healthcare
Charlotte, North Carolina, 28207
Cook County Health
Chicago, Illinois, 60612
University of Illinois at Chicago
Chicago, Illinois, 60612
Duke University
Durham, North Carolina, 27701
LANet
Los Angeles, California, 90802
COPD Foundation
Miami, Florida, 33134
Oregon Rural Practice-based Research Network (ORPRN)
Portland, Oregon, 97239
About this study
Official title: The CAPTURE Study: Validating a Unique Chronic Obstructive Pulmonary Disease (COPD) Case Finding Tool in Primary Care
A prospective multi-center study to define the sensitivity and specificity of CAPTURE for identifying previously undiagnosed patients with clinically significant COPD in a broad range of primary care settings.
Read the detailed description
The CAPTURE tool consists of a 5-item self-administered questionnaire and selected use of peak expiratory flow (PEF) measurement, designed to identify clinically significant COPD.
For Aim 1 approximately 5,000 patients will be recruited across 100 participating primary care clinics. Eligible participants will undergo a baseline visit during which the CAPTURE tool and PEF will be obtained, as well as spirometry and other participant characteristics.
- Being tested
- CAPTURE Tool
- Keywords
- CAPTURE, COPD
- 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.
CAPTURE ToolOther
CAPTURE Tool: a self administered 5-item questionnaire with peak expiratory flow measurements
| Study group | Role | What they receive |
|---|---|---|
| Participants without a diagnosis of COPD | Men and women aged 45 to 80, who have not been diagnosed with Chronic Obstructive Pulmonary Disease (COPD) Receives: Other: CAPTURE Tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of CAPTURE to identify previously undiagnosed patients with clinically significant COPD at baseline
Sensitivity and specificity of CAPTURE to identify previously undiagnosed patients with clinically significant COPD at baseline. Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC < 0.7, plus one of the following: FEV1 < 60% predicted, or ≥ 1 exacerbation-like event within the past 12 months.
If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
Measured: Baseline
Secondary outcomes (12)
Sensitivity and specificity of CAPTURE to identify previously undiagnosed patients with clinically significant COPD across sex, ethnic groups, urban vs rural location, and educational status.
Sensitivity and specificity of CAPTURE to identify previously undiagnosed patients with COPD across sex, ethnic groups, urban vs rural location, and educational status.
Measured: Baseline
Positive and negative predictive values (PPV and NPV) in different practice settings
Positive and negative predictive values in different practice settings
Measured: Baseline
Areas under the receiving operator characteristic curve (AUC) for various cutpoints of CAPTURE and PEF (Peak expiratory flow) measurements to determine the best cutpoint for clinically significant COPD screen
AUC for various cutpoints of CAPTURE and PEF measurements to determine the best cutpoint for clinically significant COPD screen.
Measured: Baseline
AUC to identify the combination of patient/site characteristics which best discriminates those with clinically significant COPD
AUC to identify the combination of patient/site characteristics which best discriminates those with clinically significant COPD
Measured: Baseline
Sensitivity and specificity of CAPTURE to identify previously undiagnosed patients with spirometrically defined COPD at baseline
Sensitivity and specificity of CAPTURE to identify previously undiagnosed patients with Spirometrically defined COPD at baseline. Spirometrically defined COPD is defined as post-bronchodilator FEV1/FVC < 0.70.
Measured: Baseline
Sensitivity and specificity of CAPTURE to identify previously undiagnosed patients with spirometrically defined COPD across sex, ethnic groups, urban vs rural location, and educational status.
Sensitivity and specificity of CAPTURE to identify previously undiagnosed patients with spirometrically defined COPD across sex, ethnic groups, urban vs rural location, and educational status. Spirometrically defined COPD is defined as post-bronchodilator FEV1/FVC < 0.70
Measured: Baseline
Areas under the receiving operator characteristic curve (AUC) for various cutpoints of CAPTURE and PEF (Peak expiratory flow) measurements to determine the best cutpoint for spirometrically defined COPD screen
AUC for various cutpoints of CAPTURE and PEF measurements to determine the best cutpoint for spirometrically defined COPD (FEV1/FVC < 0.70) screen.
Measured: Baseline
AUC to identify the combination of patient/site characteristics which best discriminates those with spirometrically defined COPD
AUC to identify the combination of patient/site characteristics which best discriminates those with spirometrically defined COPD (FEV1/FVC < 0.70).
Measured: Baseline
Sensitivity and specificity of CAPTURE to identify previously undiagnosed patients with mild COPD at baseline
Sensitivity and specificity of CAPTURE to identify previously undiagnosed patients with mild COPD at baseline. Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC < 0.7, plus both of the following: FEV1 > 60% predicted and no prior history of COPD exacerbation.
Measured: Baseline
Sensitivity and specificity of CAPTURE to identify previously undiagnosed patients with mild COPD across sex, ethnic groups, urban vs rural location, and educational status.
Sensitivity and specificity of CAPTURE to identify previously undiagnosed patients with mild COPD across sex, ethnic groups, urban vs rural location, and educational status. Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC < 0.7, plus both of the following: FEV1 > 60% predicted and no prior history of COPD exacerbation.
Measured: Baseline
Areas under the receiving operator characteristic curve (AUC) for various cutpoints of CAPTURE and PEF (Peak expiratory flow) measurements to determine the best cutpoint for mild COPD screen
AUC for various cutpoints of CAPTURE and PEF measurements to determine the best cutpoint for mild COPD screen. Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC < 0.7, plus both of the following: FEV1 > 60% predicted and no prior history of COPD exacerbation.
Measured: Baseline
AUC to identify the combination of patient/site characteristics which best discriminates those with mild COPD
AUC to identify the combination of patient/site characteristics which best discriminates those with mild COPD. Mild COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC < 0.7, plus both of the following: FEV1 > 60% predicted and no prior history of COPD exacerbation.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2018
- Study start12 Oct 2018
- Primary completion1 Apr 2022
- Study completion1 Apr 2022
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 Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 4,679 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), University of Michigan, National Jewish Health, University of Minnesota, Duke University, Wake Forest University Health Sciences, Oregon Health and Science University, High Plains Research Network, L.A. Net Community Health Resource Network, COPD Foundation, University of Kentucky
- Responsible party
- Sponsor
- Investigators
- Fernando J Martinez, MD, MS, Principal investigator, Weill Medical College of Cornell UniversityMeiLan Han, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03581227
- Sponsor's protocol ID
- 1803019032-1
- Other IDs
- R01HL136682-01
- Acronym
- CAPTURE
- Status last verified
- Jun 2023
- First submitted
- 26 Jun 2018
- Last updated
- 7 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Martinez FJ, Yawn BP, Angulo D, Lopez C, Murray S, Mannino D, Anderson S, Dolor R, Elder N, Joo M, Khan I, Knox LM, Meldrum C, Peters E, Spino C, Tapp H, Thomashow B, Zittleman L, Brown R, Make B, Han MK; CAPTURE Study Group. Impact of the CAPTURE Chronic Obstructive Pulmonary Disease Screening Tool in U.S. Primary Care: A Cluster-Randomized Trial. Am J Respir Crit Care Med. 2025 May;211(5):789-802. doi: 10.1164/rccm.202405-0921OC.
PubMed 39715575
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The CAPTURE Study: Validating a Unique Chronic Obstructive Pulmonary Disease (COPD) Case Finding Tool in Primary Care
- ClinicalTrials.gov ID
- NCT03581227
- Acronym / sponsor ID
- CAPTURE / 1803019032-1
- Keywords
- CAPTURE, COPD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,679 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), University of Michigan, National Jewish Health, University of Minnesota, Duke University, Wake Forest University Health Sciences, Oregon Health and Science University, High Plains Research Network, L.A. Net Community Health Resource Network, COPD Foundation, University of Kentucky
- Study start
- 12 Oct 2018 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 10 Jul 2018 (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.
A prospective multi-center study to define the sensitivity and specificity of CAPTURE for identifying previously undiagnosed patients with clinically significant COPD in a broad range of primary care settings.
Detailed description
The CAPTURE tool consists of a 5-item self-administered questionnaire and selected use of peak expiratory flow (PEF) measurement, designed to identify clinically significant COPD.
For Aim 1 approximately 5,000 patients will be recruited across 100 participating primary care clinics. Eligible participants will undergo a baseline visit during which the CAPTURE tool and PEF will be obtained, as well as spirometry and other participant characteristics.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants without a diagnosis of COPD | – | Other: CAPTURE ToolMen and women aged 45 to 80, who have not been diagnosed with Chronic Obstructive Pulmonary Disease (COPD) |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult men and women recruited from a broad range of primary care settings across the United States.
Key inclusion criteria (3 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 45-80 years
Key exclusion criteria (8 listed)
- Previous clinician provided diagnosis of COPD
- Treated respiratory infection (with antibiotics and/or systemic steroids) in the past 30 days of baseline
- Participants unable to perform spirometry due to any of the following conditions within the past 30 days of baseline
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 |
|---|---|---|
| CAPTURE ToolCAPTURE Tool: a self administered 5-item questionnaire with peak expiratory flow measurements | Other | Participants without a diagnosis of COPD |
Primary outcome
Sensitivity and specificity of CAPTURE to identify previously undiagnosed patients with clinically significant COPD at baseline
Time frame: Baseline
Sensitivity and specificity of CAPTURE to identify previously undiagnosed patients with clinically significant COPD at baseline. Clinically significant COPD is defined as participants with abnormal spirometry, defined as post-bronchodilator FEV1/FVC < 0.7, plus one of the following: FEV1 < 60% predicted, or ≥ 1 exacerbation-like event within the past 12 months. If a participant is unable to complete a post-bronchodilator spirometry (refusal, technical error on the part of coordinator, etc.), and the pre-bronchodilator FEV1/FVC is less than 0.65, the participant will be considered to have COPD for the purpose of follow-up in this study.
12 secondary outcomes
Sensitivity and specificity of CAPTURE to identify previously undiagnosed patients with clinically significant COPD across sex, ethnic groups, urban vs rural location, and educational status.
Time frame: Baseline
Positive and negative predictive values (PPV and NPV) in different practice settings
Time frame: Baseline
Areas under the receiving operator characteristic curve (AUC) for various cutpoints of CAPTURE and PEF (Peak expiratory flow) measurements to determine the best cutpoint for clinically significant COPD screen
Time frame: Baseline
AUC to identify the combination of patient/site characteristics which best discriminates those with clinically significant COPD
Time frame: Baseline
Sensitivity and specificity of CAPTURE to identify previously undiagnosed patients with spirometrically defined COPD at baseline
Time frame: Baseline
Sensitivity and specificity of CAPTURE to identify previously undiagnosed patients with spirometrically defined COPD across sex, ethnic groups, urban vs rural location, and educational status.
Time frame: Baseline
Areas under the receiving operator characteristic curve (AUC) for various cutpoints of CAPTURE and PEF (Peak expiratory flow) measurements to determine the best cutpoint for spirometrically defined COPD screen
Time frame: Baseline
AUC to identify the combination of patient/site characteristics which best discriminates those with spirometrically defined COPD
Time frame: Baseline
Sensitivity and specificity of CAPTURE to identify previously undiagnosed patients with mild COPD at baseline
Time frame: Baseline
Sensitivity and specificity of CAPTURE to identify previously undiagnosed patients with mild COPD across sex, ethnic groups, urban vs rural location, and educational status.
Time frame: Baseline
Areas under the receiving operator characteristic curve (AUC) for various cutpoints of CAPTURE and PEF (Peak expiratory flow) measurements to determine the best cutpoint for mild COPD screen
Time frame: Baseline
AUC to identify the combination of patient/site characteristics which best discriminates those with mild COPD
Time frame: Baseline
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 7 Jun 2023.
- Derived from this study: PubMed 39715575Martinez FJ, Yawn BP, Angulo D, Lopez C, Murray S, Mannino D, Anderson S, Dolor R, Elder N, Joo M, Khan I, Knox LM, Meldrum C, Peters E, Spino C, Tapp H, Thomashow B, Zittleman L, Brown R, Make B, Han MK; CAPTURE Study Group. Impact of the CAPTURE Chronic Obstructive Pulmonary Disease Screening Tool in U.S. Primary Care: A Cluster-Randomized Trial. Am J Respir Crit Care Med. 2025 May;211(5):789-802. doi: 10.1164/rccm.202405-0921OC.
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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.
Fernando J Martinez, MD, MS principal investigator
Weill Medical College of Cornell University
MeiLan Han principal investigator
University of Michigan
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease (COPD), run by Weill Medical College of Cornell University at 8 sites 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 3 inclusion and 8 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 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
Sensitivity and specificity of CAPTURE to identify previously undiagnosed patients with clinically significant COPD at baseline (time frame: Baseline). 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 NCT03581227, 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 7 Jun 2023.