Hiremath 2006.
Methods | Design: randomised controlled trial following a baseline period of 2 to 4 weeks (rescue medication only) and an intervention period of 12 weeks Location and number of centres: not reported |
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Participants | Number screened: not reported Number randomised: 512 Number completed: not reported Age: children and adolescents (4 to 15 years) with predominantly moderate‐to‐severe asthma Gender: not reported Asthma severity: forced expiratory volume in 1 second (FEV1) 50‐90% of predicted Inclusion/exclusion criteria: not reported |
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Interventions | Ciclesonide 160 μg (ex‐actuator; N = 254) once daily in the evening Fluticasone 88 μg twice daily (176 μg/day, ex‐actuator; N = 258) Delivery: both medications were administered via a metered‐dose inhaler with spacer (AeroChamber Plus®) Inhalation technique: not reported Treatment period: 12 weeks (following 2 to 4 weeks' baseline period rescue medication only) Allowed asthma medication: not reported |
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Outcomes | FEV1 from baseline to the end of the treatment period, morning peak expiratory flow, median percentage of asthma symptom‐ and rescue medication‐free days and incidence of adverse events | |
Notes | Incomplete data since this study was only published as an abstract | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding (performance bias and detection bias) Outcomes 1, 3, 4, 5 | Unclear risk | Not described |
Blinding (performance bias and detection bias) Other outcomes | Unclear risk | Not described |
Incomplete outcome data (attrition bias) Outcomes 1, 3, 4, 5 | Unclear risk | Not described |
Incomplete outcome data (attrition bias) Other outcomes | Unclear risk | Not described |
Selective reporting (reporting bias) | Unclear risk | Not enough information |
Other bias | Unclear risk | Not enough information |