Respiratory trials depend on what happens between visits: morning and evening peak flow, symptoms, night waking and reliever use. This template records all three peak flow blows, so the best value and variability are derived the same way for everyone.
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Asthma diary · Morning
Subject 004-0008 · Run-in day 9 · Demo study
Peak flow, blow 1
Peak flow, blow 2
Peak flow, blow 3
Measured before any inhaler this morning?
Did asthma wake you last night?
Reliever puffs since your last entry
At a glance
Why it matters
Spirometry at visits shows lung function on one morning every few weeks. Asthma changes by the day and by the hour, so trials add a home diary: peak flow morning and evening, how bad symptoms were, whether asthma woke the participant and how much reliever they used. Those measures can feed secondary endpoints, define a worsening or exacerbation signal in the protocol, and show whether background treatment was stable during run-in.
Paper peak flow charts suffer from the same problems as any paper diary: values filled in later, a single value written instead of the best of three, and missing evenings. In a phone diary each session is its own time-stamped entry, the three blows are separate numeric fields, and the questions are the same every time. The EDC for COPD and asthma trials page covers the wider study: run-in, spirometry, exacerbation forms and visit-based questionnaires.
The Global Initiative for Asthma (GINA) strategy report is updated every year; the 2026 edition was published in May 2026. It describes PEF as the highest of three readings and gives the diurnal variability calculation used for diagnosis. Use the same meter model for every participant: different meter types can read differently, and a change of meter mid-study changes the numbers. This page is not clinical advice.
Template
The morning entry covers the night; the evening entry covers the day. Both use the same form with a session question.
| Field | Question type | Values or unit | Why it is there |
|---|---|---|---|
| Session | Single choice | Morning, evening | Morning PEF is often the primary diary measure |
| Time of measurement | Time | hh:mm | Checks the session fell in its window |
| Before any inhaler | Single choice | Yes, no | Pre-bronchodilator values only, if the protocol says so |
| PEF blow 1, 2 and 3 | Numeric | L/min, whole number | Best and spread derived in analysis |
| Asthma symptoms in this period | Single choice | None, mild, moderate, severe | Simple symptom severity, defined in help text |
| Woken by asthma (morning entry) | Single choice | No, once, more than once | Night-time control |
| Reliever puffs since last entry | Numeric | Puffs, 0 to 40 | Rescue use, a common secondary endpoint |
| Activities limited by asthma (evening entry) | Single choice | No, a little, a lot | Day-time impact |
| Took controller inhaler as prescribed today | Single choice | Yes, no, partly | Background treatment adherence |
| Unscheduled care or oral steroids | Single choice | No, yes | The site follows up and completes an exacerbation form |
Symptom wording here is generic. Do not paste items from the ACT, ACQ or other licensed questionnaires into this diary.
Derived values
Personal best is usually the highest PEF a participant records over a period when their asthma is well controlled, often taken from the run-in. Write the rule into the protocol: which days count, and whether it is fixed at randomisation or updated. Once it is fixed, each session's best blow divided by personal best, times 100, gives % personal best. For example, a best blow of 430 L/min against a personal best of 520 L/min is about 83%.
Many asthma action plans group % personal best into zones: 80% and above, 50% to under 80%, and under 50%. In a trial, zones are usually defined by the protocol for worsening rules, not by a diary screen. Capture's calculated fields cover a fixed set of clinical formulas and do not include % personal best or diurnal variability, so these values are derived in analysis from the export, with the data dictionary explaining each variable. If participants have their own action plan, tell them in the help text to follow it, and keep the diary for recording.
Timing
Most asthma trials start the diary in a run-in of two to four weeks, which establishes personal best and baseline reliever use and shows who can keep the routine. The diary then runs through treatment. Set a morning task and an evening task, each with a completion window, so entries cannot be filled in days later. Reminders go out by email or SMS, the ladder sends up to three per task, and quiet hours in the participant's time zone are respected.
Diary data and site data sit in the same record. Spirometry belongs on site forms, and when a participant reports unscheduled care, the site follows up on an exacerbation or adverse event eCRF. Background inhalers go on the concomitant medications eCRF.
| Assessment | Scr | Run-in | BL | W4 | W12 | W24 |
|---|---|---|---|---|---|---|
| Spirometry (site) | ||||||
| Morning PEF and night entry | D | D | D | D | D | |
| Evening PEF and day entry | D | D | D | D | D | |
| Personal best fixed | ||||||
| Asthma control questionnaire (licensed) |
D = daily diary entries, two sessions a day
Build the diary in the free sandbox and complete a morning entry on your own phone in under a minute.
Adapt it
One meter model for all participants, recorded on a site form.
Three blows each session, all recorded; best derived in analysis.
Morning before inhalers, evening at a set time, each with a window.
Run-in days used and whether it is updated.
PEF drop, reliever use or symptom rules written in the protocol.
ACT or ACQ built separately, with permission and licence details recorded.
Morning and evening peak flow with all three blows, time of measurement, whether it was before any inhaler, symptom severity, night waking, reliever puffs, activity limitation, controller use and unscheduled care.
PEF is reported as the highest of three. Storing all three lets the analysis take the best value consistently and check how reproducible the blows were.
Divide the session's best PEF by the participant's personal best and multiply by 100. In this template it is derived in analysis, using the personal best rule in your protocol.
For each day, take the highest minus the lowest reading and divide by their mean, then average over one to two weeks. GINA treats more than about 10% in adults as excessive.
Yes, as a separate questionnaire once you have permission. The ACT is copyrighted and licensed; see the ACT template page for its terms. This diary contains no ACT or ACQ items.
Yes. It is a generic diary. Build it in the free sandbox with no credit card and pay only when you go live with real participants.
Three blows, symptoms and reliever use in one phone diary, next to your site data. Free sandbox, no credit card, pay only when live.