Pedersen 2006.
| Methods | Design: 12‐week, randomised, multicentre, double‐blind, double‐dummy, 2‐arm, parallel group study, with a 2‐ to 4‐week baseline period Location and number of centres: 51 centres in Europe, South Africa and Canada |
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| Participants | Number screened: 728 enrolled
Number randomised: 556 (baseline details given for per‐protocol set. Ciclesonide: N = 277; fluticasone: N = 279)
Number completed: not reported. Age: median 10 years Gender: 331 boys; 180 girls Baseline details: add‐on therapy prior to baseline: ciclesonide N = 80, 64%; fluticasone N = 170, 66%; inhaled corticosteroid (ICS) therapy prior to baseline: ciclesonide N = 162, 31%; fluticasone N = 67, 27%; mean ICS dose: 390 μg/day overall; mean forced expiratory volume in 1 second (FEV1): 1.7 L overall; mean FEV1 % predicted: 80% overall; mean reversibility change in FEV1: 20% Inclusion criteria: aged 6 to 15 years; persistent asthma for at least 6 months (American Thoracic Society criteria); clinically stable for 4 weeks prior to study entry; FEV1 predicted: 50‐90% rescue medication only, 80‐100% in patients treated with ICS only; symptom score > 1 on 6 of last 10 days of run‐in; adequate metered dose inhaler (MDI) device technique without spacer Exclusion criteria: history of life‐threatening asthma; 2 or more inpatient hospitalisations in previous year; > 60 days of systemic corticosteroids in past year; > 400 budesonide or equivalent/day in 30 days prior to baseline; > 8 puffs short‐acting beta2‐agonist/day for 3 consecutive days during run‐in |
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| Interventions | 1. Ciclesonide 100 μg twice daily
2. Fluticasone 100 μg twice daily Delivery: hydro‐fluoroalkane metered dose inhaler Inhalation technique: adequate inhalation technique no details described Treatment period: 12 weeks (following 2‐ to 4‐week baseline period with rescue medication (beta2 agonist only) Allowed asthma medication: not reported |
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| Outcomes | FEV1, clinic peak expiratory flow (PEF), a.m. PEF, p.m. PEF, symptoms, rescue medication usage, adverse events | |
| Notes | Analysis of co‐variance included age and randomisation values as co‐variates and sex, treatment, and region/country as fixed factors Funding: Grant sponsor: ALTANA Pharma AG, Konstanz, Germany. This study was supported by ALTANA Pharma, Konstanz, Germany. The authors would like to thank Pro Ed Communications, Inc., Beachwood, also all Medicus International, London, UK for their editorial assistance. Editorial support was funded by ALTANA Pharma. Dr. Søren Pedersen has received remuneration for lectures from AstraZeneca and GlaxoSmithKline and served as a paid consultant for ALTANA Pharma and AstraZeneca. Ilse Theron is an employee of ALTANA Madaus Ltd, Woodmead, South Africa. Dr. Renate Engelstatter is an employee of ALTANA Pharma AG, Konstanz, Germany |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Randomization was based on a computer‐generated list (Program RANDOM) provided to the study centres by ALTANA Pharma AG (Konstanz, Germany)" |
| Allocation concealment (selection bias) | Unclear risk | No information provided |
| Blinding (performance bias and detection bias) Outcomes 1, 3, 4, 5 | Low risk | Quote: "Neither the investigator nor anyone at the study centre knew whether ciclesonide or fluticasone was administered" |
| Blinding (performance bias and detection bias) Other outcomes | Low risk | Quote: "Neither the investigator nor anyone at the study centre knew whether ciclesonide or fluticasone was administered" |
| Incomplete outcome data (attrition bias) Outcomes 1, 3, 4, 5 | Unclear risk | Not described which values used in intention‐to‐treat (ITT) analysis |
| Incomplete outcome data (attrition bias) Other outcomes | Unclear risk | Not described which values used in ITT analysis |
| Selective reporting (reporting bias) | Low risk | The results of all outcomes described in methods were reported |
| Other bias | Low risk | Small differences in baseline characteristics |