| Literature DB >> 20194353 |
P J Vuillermin1, C F Robertson, J B Carlin, S L Brennan, M I Biscan, M South.
Abstract
OBJECTIVE: To evaluate the efficacy of a short course of parent initiated oral prednisolone for acute asthma in children of school age.Entities:
Mesh:
Substances:
Year: 2010 PMID: 20194353 PMCID: PMC2830420 DOI: 10.1136/bmj.c843
Source DB: PubMed Journal: BMJ ISSN: 0959-8138
Daytime and night time symptom score diary18
| How much of the time did you have trouble breathing today? | None of the time | A little of the time | Some of the time | A good bit of the time | Most of the time | All of the time |
| Circle one number | 0 | 1 | 2 | 3 | 4 | 5 |
| How much did your asthma bother you today? | Did not bother me | Bothered me a little | Bothered me somewhat | Bothered me a good deal | Bothered me very much | Bothered me as much as possible |
| Circle one number | 0 | 1 | 2 | 3 | 4 | 5 |
| How much of the time did your asthma limit your activity today? | None of the time | A little of the time | Some of the time | A good bit of the time | Most of the time | All of the time |
| Circle one number | 0 | 1 | 2 | 3 | 4 | 5 |
| Were you woken by asthma? (either during the night or in the morning) | No | Once | More than once | Awake all night | ||
| Circle one number | 0 | 1 | 2 | 3 | ||
The daytime symptom score was calculated by adding the circled response (0 to 5) for each of the three daytime questions (total 15). A mean score was derived over a seven day period. The night time symptom score was calculated from the response (0 to 3) to the single night time question. A mean score was derived over a seven night period.

Fig 1 Flowchart of recruitment, randomisation, and follow-up of participants and episodes *Episodes=episodes of acute asthma for which the parent initiated treatment with the study medication. **In each case the protocol violation consisted of ceasing the trial medication early because symptoms had improved (without substitution for a known oral corticosteroid)
Baseline characteristics of participants who contributed episodes
| All participants who contributed episodes (n=131) | Participants who contributed a single episode only (n=55) | Participants who contributed more than one episode (n=76) | |||
|---|---|---|---|---|---|
| At enrolment | At study completion | Prednisolone (n=27) | Placebo (n=28) | ||
| Age (mean (SD)) in years | 7.9 (2.1) | 10.6 (2.3) | 8.0 (2.3) | 7.7 (1.9) | 7.9 (2.1) |
| Male sex | 89 (69) | — | 20 (71) | 20 (74) | 49 (64) |
| Atopic sensitisation | 94 (72) | — | 20 (74) | 23 (82) | 51 (67) |
| History of eczema | 76 (58) | — | 16 (59) | 18 (64) | 42 (55) |
| Asthma interval symptoms | 56 (43) | 50 (38) | 11 (41) | 13 (46) | 32 (42) |
| Prescribed regular use of an asthma preventive | 89 (68) | 59 (45) | 19 (70) | 22 (79) | 48 (63) |
Values are numbers (percentages) unless otherwise indicated.
Symptom scores, asthma-free days, days of school missed by the participant, and days of work missed by the parent
| Number (%) of diaries with relevant items completed | Mean (SD) | Ratio or difference* (95% CI) | P value | |
|---|---|---|---|---|
| Prednisolone | 140/155 (90) | 1.19 (0.74) | 0.85 (0.74 to 0.98) | 0.023 |
| Placebo | 136/153 (89) | 1.35 (0.67) | — | — |
| Prednisolone | 141/155 (91) | −0.77 (1.00) | 0.84 (0.7 to 1.0) | 0.050 |
| Placebo | 137/153 (90) | −0.54 (0.84) | — | — |
| Prednisolone | 141/155 (91) | 1.8 (1.8) | 0.3 (−0.1 to 0.6) | 0.124 |
| Placebo | 139/153 (91) | 1.5 (1.7) | — | — |
| Prednisolone | 150/155 (97) | 1.8 (1.9) | −0.4 (−0.8 to 0.0) | 0.045 |
| Placebo | 147/153 (96) | 2.2 (2.2) | — | — |
| Prednisolone | 131/155 (85) | 0.7 (1.4) | −0.1 (−0.4 to 0.3) | 0.765 |
| Placebo | 131/153 (86) | 0.8 (1.4) | — | — |
*Mean and standard deviation (SD) for daytime symptom scores and night time symptom scores were calculated from natural log values, whereas the comparisons were back transformed to give geometric mean ratios comparing prednisolone with placebo. To ensure non-negative values for log transformation, one half of the minimum score (1/14=0.071) was added to the night time symptom scores before transformation.

Fig 2 Subgroup analysis of the effect of prednisolone compared with placebo on daytime symptom score (DTSS) and health resource use (HRU). n=number of episodes treated with study medication where participants had the given subgroup characteristic
Health resource use and study medication substitution
| Outcome | Prednisolone (n=155 ) | Placebo (n=153) | Odds ratio (95% CI) | P value | Number of episodes needed to treat (95% CI) |
|---|---|---|---|---|---|
| Local doctor review* | 36/155 (23%) | 53/153 (35%) | 0.57 (0.35 to 0.92) | 0.022 | 8.3 (4.5 to 50.0) |
| Emergency department review* | 15/155 (10%) | 21/153 (14%) | 0.67 (0.33 to 1.34) | 0.254 | 25 (9.1 to ∞) |
| Hospital admission* | 6/155 (4%) | 12/153 (8%) | 0.41 (0.16 to 1.05) | 0.064 | 25 (10.7 to ∞) |
| Health resource use† | 48/155 (31%) | 69/153 (45%) | 0.54 (0.34 to 0.86) | 0.010 | 7.1 (4.0 to 30.3) |
| Study medication changed to an oral corticosteroid following a medical review | 30/155 (19%) | 54/153 (35%) | 0.44 (0.26 to 0.73) | 0.002 | 6.2 (3.9 to 16.1) |
| Study medication changed to an oral corticosteroid because episode resulted in health resource use | 30/48 (63%) | 54/69 (78%) | 0.44 (0.21 to 0.95) | 0.047 | — |
*Local doctor review, emergency department review, and hospital admission are not reported as mutually exclusive outcomes.
†Health resource use comprises local doctor, paediatrician, or emergency department review.