Study design and subjects
This is a multicenter observational prospective cohort study named IRAM (Impact of Rhinitis on Atopic March; UMIN000004157). Children aged 6–23 months with physician-diagnosed atopic dermatitis (AD), food allergy (FA) and/or AR were recruited from 30 sites in the central region of Japan in 2011 by investigators of the IRAM study group in Kinki Hokuriku Airway Disease Conference (KiHAC).14 The IRAM study aimed to delineate atopic march in high-risk infants, focusing especially on development of AR and asthma. Children who had been diagnosed with asthma were not enrolled. In the on-going follow-up of the IRAM cohort, the first part consisted of 5 visits—at 6-month intervals—in the first 2 years.13 At enrollment, the following background factors were surveyed: the family history of allergic diseases, history of wheezing not diagnosed as asthma, history of lower respiratory infections, number of siblings, environmental factors such as pets and passive smoking at home, and other medical information. Every 6 months, the study physicians diagnosed asthma based on the Japanese guidelines for pediatric asthma.15Blood and nasal secretion samples were collected at enrollment, 1 year and 2 years.
The study was approved by the Ethics Committee of Mie National Hospital, (#21-9). The parents/guardians of all participants gave written informed consent.