Rebuck 1987.
Methods | Design: SPPG Dates: N/S Location: Canada Assessment period: 90 min External validity: 2/5 COPD dx+ COPD bl‐ AECB dx‐ AECB sev+ Tx duration‐ Internal validity: 5/5 r+, db+, dd |
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Participants | N = 52 with acute exacerbation of COPD (see Notes) Setting: 4 EDs Inclusion (COPD): ATS criteria (1962) Inclusion (AcEx): Age > 18 yrs; FEV1 < 70% of predicted Exclusion: Complicating medical illnesses (e.g., pneumonia, pulmonary edema, acute myocardial infarction, frequent ventricular ectopic beats); pregnancy or breastfeeding; use of nebulized bronchodilator in previous 6 hrs; need for medications other than those specified in study protocol Smoking history: N/S Baseline stable FEV1: N/S FEV1 at admission: 0.67 ± 0.29 (SD) L (28% of predicted) (COPD pts only) Age: 66.2 (COPD pts only) Sex: 28 M, 23 F Race: N/S |
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Interventions | Experimental: Nebulized ipratropium 0.5 mg + fenoterol 1.25 mg, single dose Control 1: Nebulized ipratropium 0.5 mg, single dose Control 2: Nebulized fenoterol 1.25 mg, single dose Co‐interventions: Aminophylline IV or corticosteroids IV could be used at discretion of attending physician; all other drugs proscribed |
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Outcomes | FEV1: Mean change from pre‐treatment to 45 and 90 min | |
Notes | RESULTS
FEV1: Each of the three treatment regimens produced a significant improvement in FEV1 from 0 to 90 min (p < 0.05). There was no significant difference among the three treatments for this outcome (p < 0.2). Mean improvement scores (± SEM) were reported in graphic form only. Pre‐treatment and 90‐min mean FEV1 scores (± SD) for the three groups were: Fenoterol: Pre‐: 0.69 ± 0.30; 90‐min: 0.88 ± 0.44 Ipratropium: Pre‐: 0.69 ± 0.26; 90‐min: 0.89 ± 0.41 Ip + Fen: Pre‐: 0.63 ± 0.31; 90‐min: 0.80 ± 0.40 Adverse events: Pts were questioned about specific AEs. Results were not reported separately for pts with asthma and COPD. The most commonly reported AEs were dry mouth (10.6% of pts taking combination treatment, 19.1% taking fenoterol alone, 7.4% taking ipratropium alone); tremor (16.7% of pts taking combination treatment, 13.2% taking fenoterol alone, 2.9% taking ipratropium alone); and bad taste (8.4% overall). Eye irritation, sweating, and dizziness were each reported by < 3% of pts overall. Dropouts: 1/52 pts (2%), from ipratropium group. No significant difference in the proportion of COPD pts receiving aminophylline IV and cortico‐steroids IV in the three treatment groups. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Low risk | Third party randomisation |