Introduction The Asthma Quality of Life Questionnaire (AQLQ) is a validated questionnaire which measures the effect of asthma on patient’s lives. AQLQ data from four phase III studies were pooled to assess how AQLQ scores are affected by treatment with fluticasone propionate (FP)/formoterol fumarate (FORM) in a single MDI (FP/FORM; flutiform ) compared with other combination treatments.
Method AQLQ data from a pooled analysis of two phase III open-label studies in patients with mild-moderate/severe asthma [pool 1; FP/FORM 50/5 or 125/5 (n = 206) vs. FP 50 + FORM 12 given together in separate inhalers and FP/salmeterol 50/25 or 125/25 (n = 206)], and a pooled analysis of two phase III double-blind studies in patients with moderate/severe asthma [pool 2; FP/FORM 250/10 (n = 294) vs. FP 250 + FORM 12 given together in separate inhalers and budesonide/FORM 200/6 (n = 295)] were analysed. AQLQ scores range from 1–7; a low score indicates the most severe impairment. Change in AQLQ from baseline to end of study was analysed using an ANCOVA. The proportion of subjects achieving a clinically relevant change of = 0.5 units was analysed using a logistic regression model.
Results In pool 1, both groups had a similar increase in overall AQLQ score from baseline to end of study (0.635 in the FP/FORM group and 0.771 in the combination group) and the percentage of patients with a clinically relevant change in overall AQLQ score was 56% and 59%, respectively. In pool 2, the mean increase in overall AQLQ score from baseline to end of study was 0.837 in the FP/FORM group and 0.756 in the combination group, with 58% and 56% of patients experiencing a clinically relevant change in overall AQLQ score, respectively. The difference between the groups in each analysis was not statistically significant.
Conclusion FP/FORM has a similar effect on the quality of life of asthma patients as other combination treatments, with a similar improvement shown in each treatment group for both pools. Over 50% of patients in both treatment groups showed a clinically relevant change in AQLQ from baseline to end of study.
Juniper EF, et al. Am J Respir Med 2002;1(6):435–40.
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