| Methods |
Design: parallel‐group
Randomisation: yes, method not stated (stratified by reversibility and site)
Blinding: double‐blind, double‐dummy
Withdrawals: stated |
| Participants |
Setting: multicentre study, hospital outpatient clinic
Number eligible: 1489
Number enrolled: 723
Number in groups: FP/SM 178, FP 183, SM 177, placebo 185
Number of withdrawals: FP/SM 53, FP 49, SM 57, placebo 59
Number completing trial: FP/SM 125, FP 134, SM 120, placebo 126
Age range: 40 to 84 years for FP versus placebo
Sex: 247 M, 121 F
Ethnicity: not stated (multicentre)
COPD diagnosis: ATS criteria, FEV1/FVC ratio <= 70%, FEV1 < 65% predicted and > 0.70 L
Severity of COPD: mean FEV1 42% predicted
Inclusion criteria: current or former smokers with >= 20 pack‐year history, chronic bronchitis, moderate dyspnoea
Exclusion criteria: current asthma, oral steroids in previous 6 weeks, abnormal clinically significant ECG, long‐term oxygen therapy, moderate or severe exacerbation in run‐in, significant medical disorder
Baseline characteristics of treatment/control groups: comparable |
| Interventions |
FP 250 µg, 2 times a day (500 µg/d)
Salmeterol 50 µg, 2 times a day
FP 250 µg/salmeterol 50 µg, 2 times a day
Placebo
Diskus
24 weeks |
| Outcomes |
Predose FEV1
2 hour post dose FEV1
Morning PEFR
Dyspnoea (Transitional Dyspnoea Index)
Supplemental salbutamol use
Health status (CRDQ)
Symptoms of chronic bronchitis (CBSQ)
Exacerbations
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: 27% FP, 32% placebo |
| Selective reporting (reporting bias) |
Low risk |
All outcomes reported |
