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. 2012 Jul 11;2012(7):CD002991. doi: 10.1002/14651858.CD002991.pub3

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)
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