Backman 1985.

Methods	Design: SPPG Location: Finland Assessment period: 7 days External validity: 2/5 COPD dx‐ COPD bl‐ AECB dx‐ AECB sev+ Tx duration+ Internal validity: 3/5 r, db, dd
Participants	N = 40 Trial included both pts with acute asthma (n = 150) and pts with acute exacerbation of COPD (n = 52). Most results were reported separately for the two types of patients. Setting: Hospitalized pts FEV1 Inclusion (COPD): Chronic bronchitis, according to criteria of the British Medical Council [no ref given] Inclusion (AcEx): Acute exacerbation of chronic bronchitis (no diagnostic criteria given) Exclusion: N/S Smoking history: N/S Baseline stable FEV1: N/S FEV1 before treatment on day 1: Ipratropium, 0.73 ± 0.35 (SD) L; fenoterol, 0.93 ± 0.56 L (n.s.; p‐value not reported) Age: Range: 48‐77 Sex: 36 M, 4 F Race: N/S Dropouts: 1/40 pts (2.5%), treatment group N/S
Interventions	Experimental: Nebulized ipratropium 0.2 mg, 3x/day Control: Nebulized fenoterol 0.5 mg, 3x/day Co‐interventions: Pts with signs of an acute infection (fever, pneumonic infiltration, and positive sputum bacteriology) were treated with antibiotics before the start of the trial; pts taking beta2‐receptor stimulants (n = 16) stopped them at least 8 hrs before starting the trial; all pts received daily physical treatment; otherwise, pts continued their usual regimens, which included oral theophyllamine (n = 7), combination treatment with ephedrine and hydroxyzine (n = 4), prednisolone (n = 2), and no continuous treatment (n = 7)
Outcomes	FEV1: Measured on the 1st and 7th day immediately before and 5, 10, 15, 30, 60, 120, and 240 min after the morning study drug administration. Investigators compared mean FEV1 scores for identical timepoints on days 1 and 7. Blood gases: Arterial PaO2 and PaCO2 measured on 1st and 7th day. Investigators analyzed change from day 1 to 7. There were no significant differences between the two treatment groups for any of the outcomes measured (no between‐group p‐values reported). Dropouts: 1/40 pts (2.5%), treatment group N/S
Notes	RESULTS: FEV1 improvements were small with both interventions. In the ipratropium group (n = 17), mean scores at 15 min (p < 0.02) and 30 min (p < 0.05) post‐treatment were significantly higher on the 7th day than on the 1st; no significant differences were noted between the 1st and 7th day at 0, 5, 10, 60, 120, or 240 min. In the fenoterol group (n = 20), mean scores at 60 min post‐treatment were significantly higher on the 7th day than on the 1st (p < 0.05); otherwise, no significant differences were observed between the 1st and 7th day. Mean pre‐treatment FEV1 scores on days 1 and 7 were: (a) Ipratropium (n = 17): Day 1, 0.73 ± 0.35 (SD) L; Day 7, 0.82 ± 0.34 L (b) Fenoterol (n = 20): Day 1, 0.93 ± 0.56 L; Day 7, 1.02 ± 0.66 L Blood gases/oximetry: Investigators stated that there were no significant changes in PaO2 or PaCO2 from day 1 to day 7 in either group, but did not report any data. Adverse events: 1/19 pts (5%) taking ipratropium and 1/20 (5%) taking fenoterol complained of a "strange feeling" Two pts in the ipratropium group who did not withdraw prematurely were unable to perform spirometry and so were not included in the FEV1 analysis
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	Information not available