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. 2001 Jan 22;2001(1):CD002984. doi: 10.1002/14651858.CD002984

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
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
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
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.
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? Low risk Third party randomisation