| Methods |
RCT: 30 day parallel group study.
Randomisation: block randomisation using a random number table.
Blinding: unblinded
Excluded: not described
Withdrawals: described
Baseline characteristics: comparable
Power calculation: not given.
Jadad Score:3 |
| Participants |
Setting: Medical Institute, Bulgaria.
44 subjects with stable, severe COPD (FEV1 < 35% pred).
Only subjects with non‐reversible obstruction included in the study.
fenoterol n=22
ipratropium n=22
mean age: 63 years
mean FEV1% predicted (SD): fenoterol‐ 24.6 (1.5); ipratropium‐22.6 (1.3).
Exclusion criteria: History of asthma, allergic rhinitis or atopy; Eosinophilia; Active lung tuberculosis or lung carcinoma; cardiovascular disorders; disorders of locomotor apparatus; Anemias; renal, liver or metabolic disorders; Hypertrophy of the prostate and glaucoma; patients with supporting inhalator and peroral corticosteroid therapy. |
| Interventions |
1) 40 mcg ipratropium, four times daily.
3) 100 mcg fenoterol, four times daily.
All medication administered via MDI for 30 days. |
| Outcomes |
Outcomes:
1) Forced expiratory parameters (FEV1, FVC)
2) Dyspnoea according to American Thoracic Society Dyspnoea Scale and Borg Scale.
3) Exercise tolerance using the six minute walk distance test. |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Computer‐generated randomisation schedule |
| Allocation concealment (selection bias) |
Low risk |
Third party randomisation |
