| Methods |
Design: cross‐over group
Randomisation: yes, method not stated
Blinding: double‐blind
Withdrawals: not stated |
| Participants |
Setting: not stated
Number eligible: not stated
Number enrolled: 22
Number in treatment group: 11
Number in control group: 11
Number of withdrawals (treatment/control): not stated
Number completing trial (treatment/control): 11/11
Age range: placebo: mean 51.36 years; ICS: mean 61.82 years
Sex: 10 M, 12 F
Ethnicity: not stated
COPD diagnosis: GOLD guidelines (5 patients mild, 6 patients moderate)
Severity of COPD: placebo FEV1 99.9% predicted; ICS FEV 77% predicted
Inclusion criteria: COPD, clinically stable, no previous hospital admission or treatment change in the last 3 months, none received oral corticosteroids in the preceding 8 weeks
Exclusion criteria: current or past Dx of asthma, RTI in past 2 weeks, cancer, thyroid disease, severe liver disease, chronic heart failure
Baseline characteristics of treatment/control groups: comparable |
| Interventions |
BDP 400 µg, 2 times a day (800 µg/day)
Placebo
Short acting β2 agonists or theophylline for symptom relief |
| Outcomes |
SGRQ score ‐ symptom, activity, impact
Pulmonary function ‐ FEV1, VC, FVC, PEF, TLC
Peripheral blood monocytes
IL‐10, IFN‐γ, MIP‐1, GM‐CSF
Serum cortisol levels |
| 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 |
