Table 2 Selected results

Ulrik[16]

No significant differences in reversibility of percent predicted FEV₁ with treatment. Mean (SE): 2.7% (0.4) versus 3.4% (0.4).

Significant differences in median (range) symptom scores during treatment.

Daytime (scale 0–5): 1.0 (0–3.4) versus 1.8 (0.1–4.0).

Night-time (scale 0–4): 0.9 (0–3.4) versus 1.6 (0.1–4.0).

Newman[22]

No significant differences in measurements with treatment (data not reported).

Symptoms significantly reduced during salmeterol compared with placebo treatment.

Scale and scores not reported.

Grove[15]

Significant differences one and six hours after single dose and six hours after four weeks of treatment. Mean change: 120 versus 10 ml after four weeks.

Boyd[10]

Significant differences in improvement with treatment. Mean difference (95% CI): for salmeterol 50 μg versus placebo 97.80 (55.6 to 139.99) ml; for salmeterol 100 μg versus placebo 117.60 (67.88 to 167.32) ml.

Significant difference in distribution of median daytime and night-time symptom scores between active treatment and placebo groups (CI 0.0 to 0.0 in all cases) but not between active treatment groups.

Daytime (scale 0–5): baseline, 2 in each group; from week 5, 1 in active treatment groups and 2 in placebo group.

Night-time (scale 0–4): baseline, 1 in placebo and salmeterol 50 μg groups and 0 in salmeterol 100 μg group; from week 1, 0 in salmeterol 50 μg group and no change in other groups.

Jones[14]

(Presented QoL results for subset of patients described in Boyd[10].)

Gupta[29]

A mean increase in predose FEV₁ of 170 ml (distibution not reported) for salmeterol vs. a mean decrease of 20 ml (distribution not reported) for placebo after 8 weeks.

Both salmeterol and placebo produced significant improvemnts in BDI scores, however the magnitude of increase was greater vs. placebo (3 vs. 1); 100% patients treated with salmeterol reported decreased cough and dyspnea vs. 69% (11/16) of placebo recipients

Mahler 2002 [30]

A mean increase of 80 ml (95%CI 35 to 125) for salmeterol vs. mean decrease of -8 ml (95%CI: -53 to 37) for placebo. Two-hour post-dose FEV₁ mean increase of 175 ml (95%CI: 116 to 234) vs. mean increase of 28 ml (95%CI: -17 to 73)

Mean increase of 0.5 (SE 0.4) in TDI for salmeterol recipients and 0.4 (SE 0.3) for placebo recipients. Not clinically or statistically significant.

Calverly [28]

A mean increase in predose FEV₁of 25 ml vs. a mean decrease of -38 ml (P < 0.05) in salmeterol and placebo recipients. Smaller difference for two-hour post-dose FEV₁ (data not reported).

Mean scores for cough (scale 0–3); breathlessness (scale 0 to 4); sputum production (scale 0 to 3); sputum colour (scale 0 to 4): salmeterol: cough 1.36 (SE0.03); breathlessness 1.59 (0.03); sputum production 1.30 (0.03) and colour 1.35 (0.03) vs. placebo: cough 1.44 (0.03); breathlessness 1.66 (0.03), sputum production 1.34 (0.03) and colour 1.36 (0.03).

Hanania[31]

A mean increase of 26 ml (95%CI: -27 to 79) for salmeterol vs. mean increase of 19 ml (95%CI: -26 to 64) for placebo. Two-hour post-dose FEV₁ mean increase of 119 ml (95%CI: 70 to 168) vs. mean increase of 71 ml (95%CI: 24 to 118)

The magnitude of TDI responses was less in non-reversible vs. reversible patients. (Data are not reported)

Salmeterol versus ipratropium versus placebo

Mahler[8]

Significant differences between active treatment and placebo groups but not between active treatment groups. Peak improvements with treatment: 155, 165, and 24 ml, respectively.

No significant differences in change of mean daytime symptom score with treatment. No significant differences in TDI except between ipratropium and placebo groups at week 8.

After 12 weeks, mean TDI 0.35, 0.98, and 0.48, respectively.

Rennard[23]

Significant differences between active treatment and placebo groups but not between active treatment groups. FEV₁AUC 0–12 hour responses significantly greater with salmeterol and ipratropium than with placebo (data not reported).

Formoterol versus placebo

Rossi[27]

Significant differences in estimated difference in FEV₁AUC 0–12 hour responses: between formoterol 12 μg and placebo groups, 145 ml; between formoterol 24 μg and placebo groups, 141 ml. (Individual values for treatment groups not available.)

Formoterol versus ipratropium versus placebo

Stahl[26]

Significant differences in improvement in percent predicted FEV₁between active treatment and placebo groups but not between active treatment groups: 13%, 7%, and 6%, respectively.

Significant differences between active treatment and placebo groups in change from baseline in breathlessness (scored 0 to 4 morning and evening). Means: -0.21, -0.29, and 0.0, respectively.