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.