Respiratory trials count exacerbations over a year, measure lung function at visits and ask participants about symptoms and rescue inhaler use every day. Capture puts the exacerbation forms, daily diaries and questionnaires in one study with one audit trail.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Onset date
EXSTDTCSystemic corticosteroids given
EXSCSAntibiotics given
EXABXEmergency visit or hospital admission
EXHOSPResolution date
EXENDTCWhat matters in COPD and asthma trials
Study design
An exacerbation endpoint is only as good as the capture of events between visits. Participants may be treated by their own doctor, an urgent care clinic or an emergency department, and the site learns about it weeks later. Trials handle this by asking about exacerbations at every contact, prompting participants to report worsening through the diary, and recording each event on its own form with onset, treatment, setting and resolution.
The definition must be applied consistently. Severity usually depends on what treatment was given and where, which is why the form should capture those facts as structured fields rather than asking the investigator for a severity label alone. Events that start within a set number of days of a previous one are often counted as the same exacerbation; write that rule into the protocol and apply it in analysis.
Most respiratory trials start with a run-in of two to four weeks to confirm eligibility, stabilise background therapy, check inhaler technique and establish diary compliance. Running the run-in diary in the same study as the treatment period keeps baseline and outcome on the same data.
| Assessment | Scr | Run-in | BL | W4 | W12 | W26 | W52 |
|---|---|---|---|---|---|---|---|
| Spirometry | |||||||
| Daily eDiary | D | D | D | D | D | D | |
| CAT | |||||||
| Exacerbation review | |||||||
| Adverse events |
D = daily diary entries
Daily diary
Participants record symptoms, night-time waking and rescue inhaler puffs each evening from a secure link, with no app to install. Completion windows prevent back-filling a week from memory, reminders prompt missed entries, and the dashboard shows participants whose compliance is slipping.
At-risk participants
Visit data
Spirometry values are numeric fields with units and range checks that raise an auto-query when a value breaks a rule. Exacerbations, adverse events and concomitant medications such as systemic corticosteroid courses live in the same study, so the events that define the endpoint and the safety data never need reconciling across systems.
Edit checks / auto-queries
2Type
Range High
Operator
Greater than
Value
180
Priority: High
Type
Range Low
Operator
Less than
Value
80
Priority: Normal
Query raised automatically
Value 192 violates limit (180). Please verify.
Try both in the free sandbox and complete the diary on your phone.
Endpoints
| Endpoint | Typical use | Data needed |
|---|---|---|
| Annualised exacerbation rate | COPD, severe asthma | Event forms with onset, treatment, setting and resolution; time on study |
| Trough or peak FEV1 | Bronchodilators, maintenance therapy | Spirometry at visits, timing relative to dose |
| Rescue medication use | Asthma and COPD | Daily diary of puffs or occasions |
| CAT or SGRQ | COPD health status | Questionnaires at visits |
| ACT or ACQ | Asthma control | Questionnaires at visits |
| Oral corticosteroid reduction | Severe asthma biologics | Con med doses over time |
Phenotypes
Modern asthma and COPD drugs often target specific inflammatory pathways, so trials enrol or stratify by biomarkers such as blood eosinophil counts or exhaled nitric oxide. Those values need to be recorded at screening as structured laboratory data with units and collection dates, verified against source, and made available to randomisation as stratification factors where the design requires it.
Because eosinophil counts vary with steroid use and time of day, protocols define when samples are taken and what counts as a qualifying value. Record the details the definition depends on. See clinical trial randomization software for stratified allocation.
Study build
Moderate and severe criteria, and the rule for separating events.
Length, compliance threshold and eligibility checks.
Timing relative to dose and central over-reading if used.
Daily diary fields and units (puffs or occasions).
CAT, SGRQ, ACT or ACQ matched to recall periods.
Biomarkers or exacerbation history configured before first randomisation.
Often the annualised rate of moderate or severe exacerbations, or lung function (FEV1) for bronchodilators.
Commonly by treatment and setting: moderate events need systemic corticosteroids or antibiotics, severe events need hospital admission or emergency care. Each protocol defines its own criteria.
Exacerbations are seasonal, so a 52-week study covers the full cycle of risk.
Yes. A daily diary opens on the participant's phone from a secure link, with windows and reminders.
No. Questionnaires and diaries open in the phone browser.
Yes, in the free sandbox with every feature.
Event forms, daily diaries and PROs in one study. Free sandbox.