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Research

Oral prednisolone for acute lower respiratory tract infection in clinically unrecognised asthma: an exploratory analysis of the Oral Steroids for Acute Cough (OSAC) randomised controlled trial

Sean Hawkey, Grace J Young, Paul Little, Michael Moore and Alastair D Hay
BJGP Open 2020; 4 (5): bjgpopen20X101099. DOI: https://doi.org/10.3399/bjgpopen20X101099
Sean Hawkey
1Center for Academic Primary Care, National Institute for Health Research (NIHR) School for Primary Care Research, Bristol Medical School, University of Bristol, Bristol, UK
2Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK
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Grace J Young
3Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, UK
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Paul Little
4Primary Care and Population Science, NIHR School for Primary Care Research, Aldermoor Health Centre, University of Southampton, Southampton, UK
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Michael Moore
4Primary Care and Population Science, NIHR School for Primary Care Research, Aldermoor Health Centre, University of Southampton, Southampton, UK
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Alastair D Hay
1Center for Academic Primary Care, National Institute for Health Research (NIHR) School for Primary Care Research, Bristol Medical School, University of Bristol, Bristol, UK
2Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK
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  • For correspondence: alastair.hay@bristol.ac.uk
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    Figure 1. Kaplan–Meier analysis of time to recovery from moderately bad or worse cough (main analysis groups)
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    Figure 2. Forest plots of the subgroups for a) duration of moderately bad or worse cough and b) mean symptom severity score. HR = hazard ratio. OSAC = Oral Steroids for Acute Cough

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    Table 1. Baseline characteristics (main analysis groups)
    Characteristics, n (%)aMain analysis group (N = 40)Rest of OSAC sample(N = 358)
    Prednisolone(n = 22)Placebo(n = 18)
    Centre
    Bristol15 (68.2)11 (61.1)205 (57.3)
    Oxford3 (13.6)3 (16.7)78 (21.8)
    Southampton3 (13.6)1 (5.6)41 (11.5)
    Nottingham1 (4.5)3 (16.7)34 (9.5)
    Demographics and past medical history
    Sex, male13 (59.1)8 (44.4)127 (35.5)
    Mean age, years (SD)53.02 (18.1)43.7 (16.6)47.2 (15.8)
    Median weight, kg (IQR)b78.0 (64.0–95.0)80.5 (70.0–94.0)76 (65.0–90.0)
    Median height, cm (IQR)c172.5 (162.0–176.0)171.5 (166.0–175.0)168 (162.0–175.0)
    Ethnic group, Whitec22 (100)16 (88.9)343 (96.1)
    Occupation
    Employed14 (63.6)10 (55.6)256 (71.5)
    Unemployed3 (13.6)2 (11.1)13 (3.6)
    Retired4 (18.2)5 (27.8)62 (17.3)
    Other1 (4.5)1 (5.5)27 (7.5)
    Median deprivation score (IQR)d18.5 (7.0–28.0)12.5 (10.0–24.5)11 (5.0–22.0)
    Smoking statusc
    Current6 (27.3)4 (22.2)59 (16.5)
    Past6 (27.3)10 (55.6)102 (28.6)
    Never10 (45.5)4 (22.2)196 (54.9)
    Lives with smokere3 (15.0)6 (35.3)48 (14.1)
    Received asthma medication>5yearspreviouslyf1 (5.0)2 (11.1)15 (4.4)
    Personal history of hay feverg6 (31.6)5 (29.4)76 (22.3)
    Personal history of eczemah2 (10.5)4 (22.2)50 (14.8)
    Family history asthmaorhay feveroreczemai9 (45.0)11 (61.1)129 (38.7)
    Influenza vaccine in last12months6 (27.3)4 (22.2)97 (27.1)
    Recruited in winter (1October–31March)14 (63.6)13 (72.2)199 (55.6)
    Clinical characteristics and management
    Median prior duration of cough, days (IQR)12.0 (7.0–21.0)14.0 (6.0–21.0)11.0 (6.0–19.0)
    Sputum, symptom <24 hourc15 (68.2)16 (88.9)274 (76.8)
    Shortness of breath, symptom <24 hour15 (68.2)12 (66.7)252 (70.4)
    Wheeze, symptom <24 hourc13 (59.1)9 (50.0)164 (45.9)
    Chest pain, symptom <24 hour11 (50.0)7 (38.9)167 (46.6)
    Median patient-reported illness severity (0–10), (IQR)j6.5 (3.0–7.0)5.0 (4.0–6.0)6.0 (4.0–7.0)
    Mean pulse rate, bpm (SD)72.9 (13.0)76.4 (10.6)78.1 (12.0)
    Mean temperature, °C (SD)36.6 (0.4)36.6 (0.5)36.6 (0.5)
    Mean oxygen saturation, % (SD)c97.6 (1.8)97.8 (0.9)97.7 (1.2)
    Baseline abnormal peak flowc11 (50.0)5 (27.8)150 (42.0)
    Abnormal respiratory rate0 (0)0 (0)3 (0.8)
    Chest recession or prolonged expiration0 (0)0 (0)1 (0.3)
    Wheeze or rhonchi, auscultation2 (9.1)2 (11.1)18 (5.0)
    Crackles or crepitations, auscultationh2 (9.1)0 (0)8 (2.2)
    Bronchial breathing0 (0)1 (5.6)1 (0.3)
    Taken prescribed β agonist in past 24 hours2 (9.1)1 (5.6)9 (2.5)
    Over-the-counter drugs taken for current cough12 (54.5)12 (66.7)243 (67.9)
    Given delayed antibiotic script4 (18.2)3 (16.7)40 (11.2)
    • aUnless otherwise stated. bWeight missing for 2 in the rest of the OSAC sample. cHeight, ethnicity, smoking status, sputum, wheeze, oxygen saturation, and abnormal peak flow data missing for one in the rest of OSAC sample. dEnglish Index of Multiple Deprivation scores (range 0–100; higher scores indicate higher levels of deprivation). Data missing for two in placebo group and seven in the rest of OSAC sample. eLiving with smoker data missing for two in the prednisolone group, one in the placebo group and seventeen in the rest of OSAC sample. fData on use of asthma medication >5 years previously missing for two patients in the prednisolone group and fifteen in the rest of OSAC sample. gPersonal history of hay fever data missing for three in the prednisolone group, one in the placebo group and seventeen in the rest of OSAC sample. hPersonal history of eczema data missing for three in the prednisolone group and twenty one in the rest of OSAC sample. iFamily history of hay fever, eczema, or asthma data missing for two in the prednisolone group and twenty five in the rest of OSAC sample. jPatient-reported illness severity scores: 0 (completely well) to 10 (extremely unwell). Missing for one in the rest of OSAC sample. hIncludes unilateral and bilateral. IQR = interquartile range. OSAC = Oral Steroids for Acute Cough. SD = standard deviation.

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    Table 2. Primary outcomes (main analysis groups)
    PrednisolonePlaceboPrednisolone versus placebo
    nMedian (IQR)nMedian (IQR)HR (95% CI);P valueTime ratioa (95% CI); P value
    Duration of moderately badorworse cough173 (2–6)143 (1–6)
     Unadjusted    1.01 (0.49 to 2.05); P = 0.991.03 (0.53 to 2.02); P = 0.94
     Adjusted for centre and baseline cough durationb     1.10 (0.47 to 2.54); P = 0.831.08 (0.59 to 1.96); P = 0.79
    Secondary additional adjustmentc1.19 (0.39 to 3.75); P = 0.750.77 (0.38 to 1.57); P = 0.47
     nMean (SD)nMean (SD)Difference in means (95%CI);Pvalue
    Mean symptom severity score,days2–4d211.83 (1.05)161.95 (0.87)
     Unadjusted    –0.13 (–0.79 to 0.53); P = 0.69
     Adjusted for centre and baseline illness severity    –0.14 (–0.78 to 0.49); P = 0.65
    Secondary additional adjustment0.02 (–1.01 to 1.07); P = 0.95
    • aTime ratio can be interpreted as the relative increase or decrease in time to resolution from moderately bad or worse cough in the prednisolone versus the placebo group. bBaseline measure of duration of cough is prior duration of cough (1–28 days) and of mean symptoms severity score is patient-reported illness severity (range 0–10). cAdjusted for centre, baseline cough duration or illness severity, factors showing imbalance at baseline (age, family history of atopy, smoking status, lives with smoker, sputum, and abnormal peak flow). dSee Method section for derivation of mean symptoms severity score (0 [least severe] to 6 [most severe]). HR = hazard ratio. IQR = interquartile range. SD = standard deviation.

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    Table 3. Secondary outcomes (main analysis groups)
    Prednisolone(N = 21)Placebo(N = 16)Prednisolone versus placebo
    Mean AUC(SD)Difference in mean AUC(95%CI);Pvalue
    Cough36.29 (25.89)34.38 (24.71)
    Unadjusted1.91 (–15.20 to 19.01); P = 0.82
    Adjusted for baselinea2.27 (–15.22 to 19.75); P = 0.79
    Phlegm20.60 (19.97)30.69 (25.42)
    Unadjusted–10.09 (–25.23 to 5.04); P = 0.19
    Adjusted for baselineb–10.35 (–26.18 to 5.48); P = 0.19
    Shortness of breath12.45 (16.13)17.56 (19.79)
    Unadjusted–5.11 (–17.10 to 6.88); P = 0.39
    Adjusted for baselineb–3.64 (–15.56 to 8.29); P = 0.54
    Wheeze15.12 (16.4)16.13 (18.93)
    Unadjusted–1.01 (–12.82 to 10.80); P = 0.86
    Adjusted for baselineb–2.10 (–13.75 to 9.54); P = 0.72
    Blockedorrunny nose15.67 (20.78)20.15 (25.66)
    Unadjusted–4.49 (–19.99 to 11.00); P = 0.56
    Adjusted for baselineb–4.24 (–19.83 to 11.34); P = 0.58
    Chest pain10.33 (14.50)5.91 (8.52)
    Unadjusted4.43 (–3.85 to 12.71); P = 0.29
    Adjusted for baselineb5.07 (–2.74 to 12.88); P = 0.17
    Fever3.48 (6.36)5.53 (14.08)
    Unadjusted–2.06 (–9.06 to 4.95); P = 0.56
    Adjusted for baselineb–2.91 (–9.25 to 3.43); P = 0.36
    Muscle ache13.74 (24.87)8.31 (14.46)
    Unadjusted5.43 (–8.75 to 19.60); P = 0.44
    Adjusted for baselineb5.84 (–8.45 to 20.13); P = 0.41
    Headache11.64 (24.67)6.88 (15.84)
    Unadjusted4.77 (–9.61 to 19.14); P = 0.51
    Adjusted for baselineb4.91 (–9.54 to 19.36); P = 0.50
    Sleep disturbance20.29 (24.84)17.94 (24.07)
    Unadjusted2.35 (–14.17 to 18.86); P = 0.78
    Adjusted for baselineb3.23 (–13.67 to 20.12); P = 0.70
    Feeling unwell19.86 (27.79)17.19 (22.54)
    Unadjusted2.67 (–14.62 to 19.96); P = 0.76
    Adjusted for baselineb1.29 (–15.35 to 17.93); P = 0.88
    Activity disturbance10.14 (13.16)10.59 (20.64)
    Unadjusted–0.45 (–11.75 to 10.85); P = 0.94
    Adjusted for baselineb–0.15 (–11.56 to 11.27); P = 0.98
    Median duration (IQR)HR(95%CI);Pvalue
    Duration of moderate-badorworse cough (censored at56days)c3 (2–6)3 (1–6)
    Unadjusted1.01 (0.50 to 2.05); P = 0.99
    Adjusted for baselineb1.01 (0.49 to 2.04); P = 0.99
    Duration of any cough (censored at56days)c18 (14–31)13 (6–26)
    Unadjusted0.68 (0.32 to 1.46); P = 0.32
    Adjusted for baselineb0.69 (0.32 to 1.48); P = 0.35
    Duration of abnormal peak flowc24 (4–n/a)d6 (4–n/a)d
    Unadjusted0.45 (0.17 to 1.24); P = 0.12
    Adjusted for baselinea0.51 (0.18 to 1.42); P = 0.21
    Adjusted for baselinee0.79 (0.22 to 2.79); P = 0.71
    n (%)OR(95%CI);Pvalue
    Consumption of antibiotics up to7days1 (4.8)1 (6.3)
    Unadjusted0.75 (0.04 to 12.99); P = 0.84
    Adjusted for delayed script0.74 (0.04 to 13.48); P = 0.84
    Consumption of antibiotics up to28daysf2 (16.7)3 (33.3)
    Unadjusted0.46 (0.07 to 3.12); P = 0.42
    Adjusted for delayed script0.38 (0.04 to 3.27); P = 0.38
    Participant agrees trial tablets helped them feel betterf6 (33.3)6 (40.0)
    Unadjusted0.75 (0.18 to 3.11); P= 0.69
    Participant agrees they would take trial tablets in futuref9 (50.0)9 (60.0)
    Unadjusted0.67 (0.17 to 2.67); P = 0.57
    Adverse eventsg
    01>116 (72.7)6 (27.3)0 (0.0)14 (77.8)4 (22.2)0 (0.0)
    Unadjusted1.31 (0.31 to 5.62); P = 0.72g
    Adjusted for baselineh1.17 (0.25 to 5.38); P = 0.84g
    • aAdjusted for prior duration of cough in days. bAdjusted for presence of symptom at baseline (including previous 24 hours). cAnalysis of duration of moderately bad or worse cough (56 days) includes 17 in the prednisolone and 14 in the placebo group (participants without moderately bad or worse cough on day 1 excluded); analysis of duration of any cough (56 days) includes 21 in the prednisolone group and 16 in the placebo group; and analysis of duration of abnormal peak flow includes 11 in the prednisolone group and 13 in the placebo group (participants with normal peak flow on day 1 excluded). dA large proportion of participants still had abnormal peak flow at 28 days – a 75th percentile could therefore not be calculated. eAdjusted for baseline cough duration and baseline abnormal peak flow. fAntibiotic analysis includes 12 in the prednisolone and 9 in the placebo group up to 28 days; patient satisfaction analysis includes 18 in the prednisolone group ad 15 in the placebo group. gOrdinal logistic regression; adverse event data available for 22 in the prednisolone group and 18 in the placebo group. hAdjusted for impression of illness severity. AUC = area under the curve. n/a = not available. SD = standard deviation.

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Oral prednisolone for acute lower respiratory tract infection in clinically unrecognised asthma: an exploratory analysis of the Oral Steroids for Acute Cough (OSAC) randomised controlled trial
Sean Hawkey, Grace J Young, Paul Little, Michael Moore, Alastair D Hay
BJGP Open 2020; 4 (5): bjgpopen20X101099. DOI: 10.3399/bjgpopen20X101099

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Oral prednisolone for acute lower respiratory tract infection in clinically unrecognised asthma: an exploratory analysis of the Oral Steroids for Acute Cough (OSAC) randomised controlled trial
Sean Hawkey, Grace J Young, Paul Little, Michael Moore, Alastair D Hay
BJGP Open 2020; 4 (5): bjgpopen20X101099. DOI: 10.3399/bjgpopen20X101099
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