OBJECTIVES: The asthma quality of life questionnaire (AQLQ) is a condition-specific measure which evaluates four domains of health-related quality of life (HRQL) important in asthmatic adults: activity limitation, symptoms, emotional function, and environmental exposure. The objectives of this study were to identify: 1) How many HRQL claims were obtained in the label of asthma products using the AQLQ; 2) HRQL measures used in trials but not mentioned in label; and 3) Reasons why to discard these measures. METHODS: The PROLabels database was searched on 12/27/2014 using “asthma” as a key word for therapeutic indication. RESULTS: Out of thirty-seven products approved for asthma (five by the EMA, and 32 by the FDA), twenty-five had PRO claims in their label. Five of them had a HRQL claim: Symbicort (budesonide/formoterol fumarate dehydrate - FDA), Advair HFA (fluticasone propionate/salmeterol xinafoate - FDA), Advair Diskus (fluticasone propionate/salmeterol xinafoate - FDA), Dulera (mometasone furoate/formoterol fumarate – FDA) and Xolair (omalizumab - EMA). In all cases, the HRQL evaluation was performed using the AQLQ. Of the 20 products with PROs in label (but not HRQL), seven had no HRQL evaluation performed, three had no medical review available, and ten had a HRQL evaluation using the AQLQ (n=8), and/or the SF-36 (n=3) [one product used both measures]. The main reasons provided for not including HRQL data in the label were lack of statistical significance between treatment groups, or not reaching clinical significance. In one case (omalizumab), the FDA argued about the improper use of the AQLQ. CONCLUSIONS: This review has shown that all HRQL claims in asthma product labels were obtained using the AQLQ, a validated measure in asthma patients with a recognized minimally important difference enabling a clear interpretation of results. For these reasons the AQLQ could be considered as a potentially acceptable measure for regulatory qualification.