Fink 1994.
| Methods | 1) Randomisation: not described. 2) Allocation concealment: not described. 3) Masking: Double blind, using identical placebo tablets to active treatment. 4) Withdraw/Drop‐out: none. 5) Duration of intervention: 1 month. 6) Design: Cross‐over groups 7) Jadad quality Score: 2 8) Location: Tel Aviv, Israel | |
| Participants | 1) Inclusion criteria:COPD, severe, stable, smokers or former smokers. 2) Definition of COPD: FEV1 less than 50% of predicted. 3)Type of exercise test: Incremental cycle‐ergometer. 4) Definition of stable COPD: not described. 5) Age: Mean = 68.5, SD 3.3 years 6) FEV1: Mean = 38.3, SD 8.6 (% pred) and Mean = 1.06, SD 2.8 (L) 7) Number of patients: 22 ( 17 men and 5 women), withdraw: 0 8) Baseline therapy: Inhalation corticosteroids and other bronchodilators. 9) Exclusion criteria: known cardiac disease or cardiac disorders shown on the baseline incremental exercise test. | |
| Interventions | THEOPHYLLINE GROUP (n = 22, completed the study)
1) Drug: Theophylline (Theotrim, Trima Lab., Israel)
2) Short or long action: Long‐action
3) Dose: 300 mg theophylline (twice daily). Patients weighing less than 60 Kg took 200 mg twice per day.
4) Washout period: 2 weeks.
5) Theophylline blood level: measured on the day of the initial baseline study and after the first week of treatment. The dose was adjusted if the level was below 55.5umol/l. This adjustment was repeated until all patients had a blood level above 55.5umol/l. PLACEBO GROUP ( n = 22, completed the study ) |
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| Outcomes | 1) Pulmonary function tests FVC (L), FVC (% pred), FEV1 (L), FEV1 (% pred). 2) Exercise testing (incremental exercise cycle ergometer test ‐ WR, VO2max, HR, respiratory rate and ventilation, VO2max/HR (maximum oxygen pulse), VEmax/MVV (dyspnoea index), anaerobic threshold (VE/VO2slope). 3) Resting arterial blood gases 4) Maximal voluntary ventilation (MVV) (L), MVV (% pred). 5) Side effects: not described. | |
| Notes | 1) Intention‐to‐treat analyses: Yes 2) Sample size and statistical power: not reported. 3) Representativity: not described. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |