Table 1.

Participants in the randomised, double blind, double dummy, parallel group, multicentre study of 52 weeks including a four week run-in period. Values are numbers (percentages) of patients

	Montelukast-fluticasone (n=747)	Salmeterol-fluticasone (n=743)
Completed the study	622 (83.3)	633 (85.2)
Discontinued the study	125 (16.7)	110 (14.8)
Clinical adverse experience	38 (5.1)	35* (4.7)
Laboratory adverse experience	0 (0)	2 (0.3)
Lack of efficacy	4 (0.5)	7 (0.9)
Protocol deviation	15 (2.0)	15 (2.0)
Lost to follow up	12 (1.6)	12 (1.6)
Patient moved	7 (0.9)	5 (0.7)
Withdrew consent	22 (2.9)	22 (3.0)
Site terminated	8 (1.1)	4 (0.5)
Other reasons	19 (2.5)	8 (1.1)

2144 patients were screened, and 1490 patients were entered into the study.

^*One patient discontinued because of an adverse experience of vomiting that started before randomisation.