Guenette 2011.
Methods | Design: cross‐over group Randomisation: yes, method not stated Blinding: double‐blind, placebo‐controlled Withdrawals: stated | |
Participants | Setting: hospital outpatient clinic Number eligible: not stated Number enrolled: 17 Number in groups: 17 (cross‐over) Number of withdrawals: 0 Number completing trial: 17 Age range: > 40 years old Sex: 12 M, 5 F Ethnicity: not stated (multicentre) COPD diagnosis: clinically stable COPD patients Severity of COPD: mean FEV1 54% predicted Inclusion criteria: > 40 years with a clinical diagnosis of COPD for at least 1 year, smoking > 20 pack‐years, FEV1 < 70% predicted, FEV1/FVC < 0.7, FRC > 120% predicted and moderate to severe chronic activity‐related dyspnoea as evidenced by a modified baseline Dyspnoea Index focal score < 6 Exclusion criteria: asthma, other condition leading to dyspnoea, hospitalised or lower respiratory tract infection 4 week prior, oxygen saturation < 80% during exercise Baseline characteristics of treatment/control groups: comparable | |
Interventions | FP 500 µg twice daily Placebo twice daily 2 weeks (with 2 weeks washout) |
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Outcomes | Borg dyspnoea score during exercise, cycle endurance, spirometry, lung volumes | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "randomised" |
Allocation concealment (selection bias) | Unclear risk | Information not available |
Blinding (performance bias and detection bias) All outcomes | Low risk | Quote: "double blind" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No withdrawals |
Selective reporting (reporting bias) | Low risk | All outcomes reported |