Fluticasone propionate/salmeterol (Advair HFA) vs Lodotra

NCT00158834 · Phase 3 · completed

The study randomized 200 children and used double blinding with an active fluticasone comparator. Its primary endpoint was the clinical measure of asthma symptom-free days, but no results are posted, so whether that endpoint was met cannot be determined.

NCT00686335 · Phase 2 · completed

This was a single-group, sequential (not randomized) study with no blinding and no true parallel control arm - patients simply switched from morning to evening dosing of the same drug class, and only 7 of 12 enrolled patients completed both periods for the efficacy analysis. The sponsor describes the study as exploratory with descriptive-only analysis and no statistical hypothesis testing, so despite numbers suggesting fewer nighttime awakenings with the evening formulation, this small, unblinded, uncontrolled design cannot serve as strong evidence.