NCT03583099: CAPTURE

The CAPTURE Study: Validating a Unique COPD Case Finding Tool in Primary Care (Aim 3)

Completed NA Results posted Last updated 19 September 2024

What this trial tests

NA trial testing COPD plus CAPTURE education and patient-level information in Chronic Obstructive Pulmonary Disease (COPD) in 2,004 participants. Completed in 7 April 2023.

Timeline

12 October 2018

Primary endpoint
7 April 2023

7 April 2023

Quick facts

Lead sponsor	Weill Medical College of Cornell University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	other
Enrollment	2,004
Start date	12 October 2018
Primary completion	7 April 2023
Estimated completion	7 April 2023
Sites	9 locations across United States

Drugs / interventions tested

• COPD plus CAPTURE education and patient-level information
• COPD Education Only

Conditions studied

• Chronic Obstructive Pulmonary Disease (COPD) — all drugs for Chronic Obstructive Pulmonary Disease (COPD) →

Sponsor

Weill Medical College of Cornell University

Who can join

Adults 45 to 80, any sex, with Chronic Obstructive Pulmonary Disease (COPD). Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Proportion of CAPTURE+ Participants Who Meet a Composite Endpoint for Diagnosis and Management of COPD Primary · Baseline to 12 months

Proportion of CAPTURE+ participants who meet one of the following (composite endpoint): 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation. CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range

Group	Value	95% CI
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results	45.9	38.3 – 53.6
Enhanced Usual Care: COPD Education	41.9	34.0 – 49.7

Proportion of CAPTURE+ Participants Who Are Referred for or Complete Clinical Spirometry Testing Secondary · Baseline to 12 months

CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.

Group	Value	95% CI
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results	30.0	22.2 – 37.9
Enhanced Usual Care: COPD Education	19.6	13.0 – 26.3

Proportion of CAPTURE+ Participants Who Are Newly Diagnosed With COPD Secondary · Baseline to 12 months

CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD. A new diagnosis of COPD is defined as COPD recorded in the participant's chart or reported by the participant via the follow-up survey.

Group	Value	95% CI
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results	13.7	8.6 – 18.7
Enhanced Usual Care Arm: COPD Education	12.4	6.2 – 18.6

Proportion of CAPTURE+ Participants With Newly Prescribed Respiratory Medication Secondary · Baseline to 12 months

Respiratory medication = long acting bronchodilator or anti-inflammatory for respiratory condition CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.

Group	Value	95% CI
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results	25.2	19.2 – 31.2
Enhanced Usual Care: COPD Education	27.9	21.5 – 34.4

Proportion of CAPTURE+ Participants Referred to a Specialist for Respiratory Evaluation/Treatment Secondary · Baseline to 12 months

CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.

Group	Value	95% CI
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results	17.4	11.8 – 23.1
Enhanced Usual Care: COPD Education	12.3	7.8 – 16.8

Proportion of CAPTURE+ Participants Who Are Referred for or Complete Pulmonary Rehabilitation Secondary · Baseline to 12 months

CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.

Group	Value	95% CI
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results	6.40	2.40 – 10.3
Enhanced Usual Care: COPD Education	7.00	2.90 – 11.20

Proportion of CAPTURE+ Participants Who Have Received a Recommendation for, or Administration of Influenza Vaccination. Secondary · Baseline to 12 months

CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.

Group	Value	95% CI
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results	84.5	79.4 – 89.5
Enhanced Usual Care: COPD Education	90.8	86.4 – 95.2

Proportion of CAPTURE+ Participants Smoking at the Baseline With Any Components of the Primary Endpoint OR Any of the 4 Events Described in the Description Below. Secondary · Baseline to 12 months

Proportion of CAPTURE+ participants currently smoking at the baseline visit who have any of the components of the Aim 3 primary endpoint: 1) referral for clinical spirometry testing, 2) new diagnosis of COPD, 3) newly prescribed respiratory medication (long acting bronchodilator or anti-inflammatory for respiratory condition), 4) referral to a specialist for respiratory evaluation/treatment, or 5) referral for or completion of pulmonary rehabilitation. OR 1\) clinical counseling or recommendation for smoking cessation, 2) referral to a smoking cessation program, 3) referral to a smoking quit

Group	Value	95% CI
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results	83.37	82.70 – 84.03
Enhanced Usual Care: COPD Education	85.90	73.93 – 97.87

Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Are Referred for or Complete Clinical Spirometry Testing Secondary · Baseline to 12 months

CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.

Group	Value	95% CI
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results	37.52	24.67 – 50.37
Enhanced Usual Care: COPD Education	24.19	8.80 – 39.58

Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Receive a New Diagnosis of COPD Secondary · Baseline to 12 months

CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD. A new diagnosis of COPD is defined as COPD recorded in the participant's chart or reported by the participant via the follow-up survey.

Group	Value	95% CI
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results	24.62	13.48 – 35.78
Enhanced Usual Care: COPD Education	23.77	8.80 – 38.74

Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Are Newly Prescribed Respiratory Medication Secondary · Baseline to 12 months

CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.

Group	Value	95% CI
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results	37.05	26.73 – 47.37
Enhanced Usual Care: COPD Education	30.22	15.88 – 44.57

Proportion of CAPTURE+ Participants Currently Smoking at Baseline Who Receive a Referral to a Specialist for Respiratory Evaluation/Treatment Secondary · Baseline to 12 months

CAPTURE+ is defined as Participants with: CAPTURE score ≥ 5, or CAPTURE score of 2, 3, or 4 with a low PEF, defined as \<350 L/min for males and \<250 L/min for females. CAPTURE scores range from 0 to 6. Higher values represent a higher likelihood of having clinically significant COPD.

Group	Value	95% CI
Intervention: COPD Education Plus CAPTURE Education and Patient-level CAPTURE Screening Results	21.58	9.55 – 33.62
Enhanced Usual Care: COPD Education	13.98	0.36 – 27.61

Sponsor's own description

A prospective, multicenter study including a cross-section validation to define sensitivity and specificity of CAPTURE to identify previously undiagnosed patients with clinically significant Chronic Obstructive Pulmonary Disease (COPD), and its impact on clinical care across a broad range of primary care settings in a cluster randomized controlled clinical trial.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Advances in Chronic Obstructive Pulmonary Disease.
   Ferrera MC, Labaki WW, Han MK. · · 2021 · cited 110× · PMID 33502902 · DOI 10.1146/annurev-med-080919-112707
2. Protocol Summary of the COPD Assessment in Primary Care To Identify Undiagnosed Respiratory Disease and Exacerbation Risk (CAPTURE) Validation in Primary Care Study.
   Yawn BP, Han M, Make BM, Mannino D, et al · · 2021 · cited 17× · PMID 33156981 · DOI 10.15326/jcopdf.2020.0155
3. Understanding Early COPD.
   Lee BY, Han MK. · · 2023 · cited 1× · PMID 37353336 · DOI 10.4187/respcare.10612