| Methods |
RCT: 85 day (two arm) parallel group inhalation solution study.
Randomisation: computer generated
Blinding: double blind
Excluded: not described.
Withdrawals: described.
Baseline characteristics: comparable
Power calculation: not given.
Intention to treat analysis: not stated
Jadad Score:4 |
| Participants |
Setting: USA, multi‐centre (11) study.
223 subjects with stable COPD.
mean age: 64 years
male/female: 60% / 40%
mean baseline FEV1: 1.00 Litres or 39% predicted. No range given.
Inclusion criteria: > or = 40 years of age, >10 year pack history of smoking, stable disease, FEV1 < or = 65% predicted, FEV1/FVC < or =70 %
Exclusion criteria: history of asthma, allergic rhinitis or atopy, total blood eosinophil count >500/mm3, recent use of large doses of corticosteroids, recent MI (3 years), use of beta blockers, chronic home oxygen, other significant disease. |
| Interventions |
1) 0.5 mg ipratropium 0.1% inhalation solution, three times daily.
2) 2.5 mg albuterol 0.5% inhalation solution, three times daily.
Medication was provided in 2.5ml vials and delivered by nebuliser, for 85 days. |
| Outcomes |
Primary outcomes measured on Test Day 1, 43, 85 : pulmonary function tests i.e.
1)Test Day baseline FEV1, FVC
2) Test Day peak change in FEV1, FVC
3) Test Day AUC above test day baseline (0‐8 hr) FEV1, FVC.
Secondary Outcomes included:
I) HRQL using the Chronic Respiratory Disease Questionnaire (CRQ) measured day 1, 43 and 85.
Secondary Outcomes measured on fortnightly clinic visits to monitor:
2) Daily PEFR‐ measured morning and evening and recorded in diary.
3) adverse events.
4) concomitant medication. |
| Notes |
Unpublished standard errors obtained from Boehringer Ingelheim and converted to standard deviations. Study quality details provided by Boehringer Ingelheim. |
| 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 |
