Instrument template · COPDUpdated September 28, 2026

COPD Assessment Test eCRF template

Eight short items on how COPD affects daily life, each scored 0 to 5, for a total of 0 to 40. The CAT is quick enough for every visit and is part of how COPD is classified, which makes it a natural eligibility and outcome measure.

  • 8 items, 0 to 40
  • Impact bands
  • Coded values in exports

Free sandbox · No credit card · 21 CFR Part 11 aligned

COPD Assessment Test · Subject 008-0031

Week 24 total

17 / 40

Medium
0-9 Low10-20 Medium21-30 High31-40 Very high
Baseline22
Week 1219
Week 2417
Impact bands on the total

At a glance

  • Eight items on cough, phlegm, chest tightness, breathlessness on exertion, activity at home, confidence leaving home, sleep and energy.
  • Each item is a 0 to 5 scale between two opposite statements; the total runs from 0 to 40, with higher scores meaning greater impact.
  • Impact bands commonly used: below 10 low, 10 to 20 medium, 21 to 30 high, above 30 very high.
  • A score of 10 or more is used in widely followed COPD strategy documents to identify patients with more symptoms.
  • A change of about 2 points is commonly cited as the minimal clinically important difference.

In trials

Where the CAT fits in a COPD study

COPD trials measure several things at once: lung function by spirometry, exacerbations, health status and symptoms. The CAT covers health status in under two minutes, which is why it is so often collected at every visit. It is also used at screening, where a minimum CAT score can define a symptomatic population for the trial.

The more detailed St George's Respiratory Questionnaire (SGRQ) remains a common primary health status endpoint in registration trials, with the CAT as a shorter secondary. If you use both, schedule them at the same visits so they can be compared.

Format

Each CAT item sits between two statements, one at each end of the scale, and the participant chooses the number that describes them. On a phone, that works best as a 0 to 5 scale with both statements shown as anchors, one item per screen.

COPD Assessment Test · Week 24

Item 4 of 8 · approved version

Breathlessness walking up a hill or one flight of stairs

CAT04
012345
Anchors from the approved version

Structure

CAT items and impact bands

ItemTopic
1Cough
2Phlegm (mucus) in the chest
3Chest tightness
4Breathlessness on hills or stairs
5Limitation of activities at home
6Confidence leaving home
7Sleep
8Energy

The CAT is copyrighted by its developer. It is widely available for use, but check the current terms and use the official wording and translations.

In Capture

At every visit, on the participant's phone or a clinic tablet

The CAT can be completed from a secure link at home before the visit or on a clinic tablet in the waiting room. Each item is stored as a coded 0 to 5 value with its label, all eight are required, and the visit window keeps collection on schedule.

  • Phone or clinic tablet.
  • Coded values and labels in every export.
  • Visit windows and reminders.
EDC for COPD and asthma trials
Clinic tablet · landscape5 of 12

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Context

Reading the CAT around exacerbations

CAT scores rise sharply during an exacerbation and recover over the following weeks. A visit that happens to fall a few days after an exacerbation can therefore look like a treatment failure. Record exacerbations on their own form with onset and resolution dates, and decide in the analysis plan whether CAT assessments taken during or shortly after an exacerbation are included, excluded or analysed separately.

The same applies to screening. A participant recovering from a recent exacerbation may score high enough to qualify but settle below the threshold once stable. Many protocols require a stable period before screening assessments for this reason.

Before go-live

CAT setup checklist

Terms checked

Current terms of use and official wording.

Eligibility threshold

Minimum CAT score written into the eligibility form if used.

Exacerbation form

Onset and resolution dates for interpreting scores.

All items required

A total needs all eight answers.

Endpoint defined

Change from baseline, responder at 2 points, or band.

Official translations

For every language used.

FAQ

Questions about this template

Something not covered here? Ask us directly.

How long does the CAT take?

About two minutes.

Can the CAT be completed at home?

Yes. It can be completed on the participant's phone before a visit or on a clinic device at the visit.

How is the CAT scored?

Eight items are each scored 0 to 5 and summed for a total of 0 to 40. Higher scores mean greater impact of COPD.

What is a high CAT score?

Totals of 21 to 30 are commonly described as high impact and above 30 as very high impact.

Why is a CAT score of 10 important?

Widely followed COPD strategy documents use 10 or more to identify patients with more symptoms.

What is the MCID for the CAT?

About 2 points is commonly cited.

Is the CAT the same as the SGRQ?

No. The SGRQ is a longer health status questionnaire. The CAT is shorter and often used alongside it.

Does Capture calculate the CAT total?

Items are stored as coded values with labels, and totals are derived from them in analysis.

COPD impact at every visit

Eight items, two minutes, clean coded data. Free sandbox.

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