Sharma 2003.
Methods | Design: randomised controlled trial Method of randomisation: not stated Means of allocation concealment: not stated Withdrawals/drop‐outs: not stated Blinding: none | |
Participants | Eligible: not stated
Randomised: 57 (group 1: 14, group 2: 14, group 3: 15, group 4: 14)
Completed: 57
Age range (years): 5 to 12
Sex (M/F): 29/28 Asthma diagnosis: unclear Inclusion criteria: history of cough, breathlessness with wheezing, RR > 30 per min, in ED for asthma Major exclusions: tuberculosis, history suggestive of tuberculosis Baseline PEF mean (SD): treatment 92 (48), control 92 (35) |
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Interventions | Setting: patients attending outpatient or casualty department for acute asthma at a hospital in India Patients were randomised to 1 of 4 groups: group 1: BDP 100 μg plus salbutamol 200 μg via MDI plus spacer; group 2: BDP 100 μg plus salbutamol 200 μg via MDI; group 3: salbutamol 200 μg via MDI plus spacer; group 4: salbutamol via MDI. The treatment was repeated every 20 min for a total of 3 treatments as needed | |
Outcomes | Clinical parameters recorded included PEF, HR, RR, blood pressure, wheezing and retractions. Laboratory parameters recorded included serum glucose, sodium, potassium and arterial blood gases | |
Notes | This trial was added in July 2005; the author was not contacted | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method of random sequence generation not reported |
Allocation concealment (selection bias) | Unclear risk | Method of allocation concealment not reported |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Trial not blinded |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Trial not blinded |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No indication of patients being withdrawn from trial |
Selective reporting (reporting bias) | Unclear risk | No apparent indication of reporting bias |