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Table 1 Patient demographics, baseline and study characteristics

From: Efficacy and safety profile of doxofylline compared to theophylline in asthma: a meta-analysis

Study, year, trial registration, and reference

Study characteristics

Study duration (weeks)

Enrolled patients

Treatments and doses

Concomitant medications for asthma

Disease characteristics

Age (years)

Male (%)

Asthma events (n/day)

Previous hospitalization for asthma (%)

FEV1 (% predicted)

Jadad score

Calzetta et al., 2018, DOROTHEO 1, ISRCTN65297911, http://www.isrctn.com/ISRCTN65297911, [8]

Multicentre, double-blind, randomized, placebo-controlled, parallel-group

12

346

Doxofylline 200 mg t.i.d., doxofylline 400 mg t.i.d., theophylline 250 mg t.i.d., placebo

Salbutamol as needed

FEV1 ≥ 50 and < 80%, ≥15% post-bronchodilator increase in FEV1

36

49

1.2

40

66

5

Calzetta et al., 2018, DOROTHEO 2, ISRCTN65297911, http://www.isrctn.com/ISRCTN22374987, [8]

Multicentre, double-blind, randomized, placebo-controlled, parallel-group

12

220

Doxofylline 400 mg t.i.d., theophylline 250 mg t.i.d., placebo

Salbutamol as needed

FEV1 ≥ 50 and < 80%, ≥15% post-bronchodilator increase in FEV1

37

45

1.0

42

67

5

Lal et al., 2015, NA, [10]

Single-centre, open, parallel-group

8

30

Doxofylline 200 mg b.i.d., theophylline 200 mg b.i.d.

Standard treatment

NA

35

NA

NA

NA

NA

1

Margay et al., 2015, NA, [9]

Single-centre, open, randomized, parallel-group

6

100

Doxofylline 400 mg b.i.d., theophylline 300 mg b.i.d.

Salbutamol as needed

FEV1 ≥ 50% and ≤ 80%, ≥12% post-bronchodilator increase in FEV1

38

45

1.7

NA

68

3

  1. FEV1 forced expiratory volume in 1 s, NA not available