Calvo 1998.
Methods | Randomised, double‐blind parallel group trial. Method of randomisation not reported Outpatient Setting |
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Participants | N = 120 (Group 1: 40; Group 2: 40; Group 3: 40). 73 M/47 F. Mean age 7.3 years (age range: 5 to 14 years). No withdrawals occurred and all participants were accounted for
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Interventions | All treatments were administered by aerochamber
2 inhalations 4 times in first hour, 2 inhalations 3 times in second hour |
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Outcomes | PEF; TAL score; need for additional treatment (salbutamol and oral steroids) | |
Notes | Trial protocol allowed for addition of salbutamol (100 mcg per inhalation, 2 inhalations after each control) to trial medicines if participants showed no response (clinical or PEF) at 30 minutes or corticosteroid therapy at 60 minutes | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not reported |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding (performance bias and detection bias) All outcomes | Low risk | Double‐blind |