Impact on quality of life during an allergen challenge research trial

Background: Quality of life (QOL) issues resulting from participation in an allergy research trial, or indeed any clinical trial, is not documented in the medical literature. Objective: To determine whether participating in a trial where allergic sym ptoms are induced has a significant impact on subjects' QOL, and to quantif y extent and duration. Methods: Subjects were recruited from a trial utilizing a controlled allerg en environment to assess anti-allergic medications. A QOL survey (consistin g of the Rhinoconjunctivitis Quality of Life Questionnaire [RQLQ] & the SF- 36) was completed at screening, on study day, and approximately 2 weeks pos t-study. Follow-up was sought from subjects' whose QOL was significantly wo rse than baseline. Results: Of 219 trial participants, 206 completed both screening and study surveys; 141 returned at least one follow-up survey; and 136 constructed th e final dataset. Mean overall scores at follow-up via RQLQ were significant ly better than screening (P <.001). Significant decreases in QOL from basel ine on study day occurred in social function on the SF-36 (P =.026) and in domains of sleep (P =.019), non-nasal symptoms (P =.05), ocular symptoms (P <.001), and nasal symptoms (P <.001) on the RQLQ. Average post-study follo w-up was 17.1 days (range = 5 to 55 days). Conclusion: Subjects participating in a trial involving allergic symptom in duction experienced a decrease of QOL in parameters specific to rhinoconjun ctivitis and social function. Subjects' QOL returned to or improved over ba seline within 21/2 weeks. Positive QOL findings are important to studies wh ere symptoms are induced and also have relevance to standard Phase 3 drug t rials.