OBJECTIVE: This literature review identifies quality of life (QOL), symptom and patient satisfaction (PS) measures that have been used effectively with adult and pediatric asthma patients in clinical trials. METHODS : A comprehensive literature review of French or English articles, published between 1995 and 1999, was conducted using Medline, Excerpta Medica and Mapi Research Institute databases. RESULTS : 331 abstracts were assessed for their relevance to asthma, QOL and PS. For adult QOL, the literature review identified six generic, ten asthma-specific, and two respiratory-disease-specific measures. A comparison of domains and psychometric properties yielded 3 generic measures (SIP, NHP, SF-36) and 4 specific measures (AQLQ-Marks; AQLQ-Juniper, LWAQ, SGRQ) that were sufficiently comprehensive, reliable, valid and responsive. For pediatric quality of life, the literature review identified four generic (FSII-R, KINDL, CHQ-PF50, and How Are You questionnaire) and specific (Life Activities Questionnaire for Childhood Asthma, Childhood Asthma Questionnaire, Pediatric Asthma Quality of Life Questionnaire and About My Asthma) measures. Generic measures were less sensitive in mild asthmatics. Additional areas of interest included patient knowledge/control of asthma, parental burden, symptom severity and frequency. Study-specific diaries assessed symptoms although evidence of their validity was seldom provided; a noteworthy exception was the Asthma Symptoms Checklist. The impact of nocturnal symptoms on sleep was rarely measured; only the LWAQ assessed sleep, which was found to be responsive to clinical changes. No other asthma-specific, validated, sleep instruments exist to date. Only five published studies on PS were found and used study-specific non-standardized measures with no evidence of formal development/validation. CONCLUSION: This review suggests the need for additional work in the assessment of responsiveness of pediatric questionnaires, further validation of PS and the impact of nocturnal symptoms on sleep and fatigue. Parental burden and patient knowledge assessments may also aid in determining mediating factors between disease, treatment and outcome.