| Methods |
Design: parallel‐group
Randomisation: yes, method not stated
Blinding: double‐blind
Withdrawals: stated |
| Participants |
Setting: multicentre study, hospital outpatient clinic
Number eligible: 300
Number enrolled: 256
Number in treatment group: 131 FP arm
Number in control group: 125
Number of withdrawals (treatment/control): 34/40
Number completing trial (treatment/control): 97/85
Age range: mean age 64.6 years FP arm, 65.7 placebo arm
Sex: 209 M, 47 F
Ethnicity: 100% Caucasian
COPD diagnosis: pre‐bronchodilator baseline FEV1/VC < 88% for men and < 89% for women of predicted normal and FEV1 < 70% of predicted normal, but > 800 mL
Inclusion criteria: aged > 40 years, established clinical history of COPD, poor reversibility of airflow obstruction (< 10% increase of FEV1) after bronchodilator, current or ex‐smokers with smoking history of at least 10 pack‐years
Exclusion criteria: not stated
Baseline characteristics of treatment/control groups: comparable |
| Interventions |
FP 500 µg, 2 times a day (1000 µg/day)
Placebo |
| Outcomes |
No of COPD exacerbations
Number of withdrawals due to COPD exacerbations
FEV1 pre‐bronchodilator
FEV1/VC
FVC
Record card symptoms ‐ cough, breathlessness
Use of relief bronchodilator
PEFR
Shuttle walking test
Borg scale
St George Respiratory Questionnaire
Adverse events |
| 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 |
Withdrawals: 26% FP, 32% placebo |
| Selective reporting (reporting bias) |
Low risk |
All outcomes reported |
