Sliwinski 2010.
| Methods | Study design: randomised, double‐blind, placebo‐controlled, parallel group study Study duration: four weeks Randomisation: yes, method not stated Blinding: double‐blind |
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| Participants | Number randomised: 566 Number in treatment group: 121 (aclidinium 200 μg plus formoterol 6 μg), 120 (aclidinium 200 μg plus formoterol 12 μg), 125 (aclidinium 200 μg plus formoterol 18 μg), 76 (aclidinium 200 μg monotherapy) Number in control group: 65 (formoterol 12 μg) or 59 (placebo) Inclusion criteria: moderate to severe COPD Exclusion criteria: not stated | |
| Interventions | Intervention: aclidinium 200 μg plus formoterol 6 μg, 12 μg or 18 μg or monotherapy with aclidinium 200 μg once daily via the Genuair, multidose dry powder inhaler Comparison: formoterol 12 μg or placebo once daily via the Genuair inhaler |
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| Outcomes |
Primary outcome: change from baseline in normalised FEV1 area under the curve over 12 hours (AUC 0‐12h) at week four Other outcomes: safety (outcomes were not mentioned specifically) |
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| Notes | This trial was available as abstract only Source of support: Almirall SA, Barcelona, Spain, and Forest Laboratories, Inc, New York, USA Study number: EUCTR2007‐004435‐30‐CZ |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Comment: insufficient information on methods of randomisation though it is a randomised trial |
| Allocation concealment (selection bias) | Unclear risk | Comment: no details were provided on allocation concealment |
| Blinding of participants and personnel (performance bias) Aclidinium versus placebo | Low risk | Double‐blind |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Double‐blind |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: insufficient information on withdrawals and the reasons in the abstract |
| Selective reporting (reporting bias) | Unclear risk | Comment: insufficient information regarding study end points and pre‐specified outcomes |
| Other bias | High risk | Comment: incomplete information for proper assessment. Publication bias cannot be ruled out as no published full text article was available though the abstract had been published since 2010 |