Infants and toddlers with recurrent wheezing (infantile asthma)
Conditions
Interventions
1. Intermittent ICS group: twice daily (morning and evening) of inhaled placebo for 48 weeks from enrollment. When the subjects develop predetermined cold symptoms or are away overnight, they will rec
micro
g of inhaled FP twice daily (morning and evening).
2. Daily ICS group: 50 &
g of inhaled FP twice daily (morning and evening) for 48 weeks from enrollment. When the subjects develop predetermined cold symptoms or are away overnight, they will receive twice daily (morning and
Sponsors
Jikei University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) An infant outpatient between the ages of 12 and 59 months at enrollment (2) Meets the modified Asthma Predictive Index (3) Meets either of the following: 1) Had 4 or more episodes of expiratory wheezing* within 1 year before enrollment 2) Had both of the following within 1 year before enrollment i) Had 3 or more episodes of expiratory wheezing* ii) Has received long-term care for asthma (administration of inhaled corticosteroids or leukotriene receptor antagonists) continuously for 3 months or longer *: A wheezing episode is defined as "difficulty of breathing accompanied by wheezing." The physician makes the decision based on an interview with the parent (caregiver). (4) Has been treated for asthma with systemic steroids (oral or injection) within 1 year before enrollment (5) Current asthmatic condition is stable (6) It has been confirmed from the parent's (caregiver's) report that the child had clearly developed upper respiratory inflammation and subsequent expiratory wheezing within 1 year before enrollment. (7) Consent to voluntarily participate in the study has been obtained in writing from the legally acceptable representative (parent or legal guardian).
Exclusion criteria
Exclusion criteria: (1) Patients in whom switching to fluticasone is difficult before enrollment (2) Patients in whom discontinuing such drugs will be difficult; LABA, theophylline, DSCG, LTRA, suplatast (3) Patients who has been treated for asthma with systemic steroids (oral or injection) for over 3 months within 1 year before enrollment (4) Patients who has been treated for asthma with systemic steroids (oral or injection) within 2 weeks before enrollment (5) Patients who cannot inhale fluticasone properly (6) Patients who are/will be treated with growth hormone (7) Patients in whom the body weight at birth was less than 2,000g (8) Patients in whom asthma severity was mild intermittent at enrollment (9) Patients who has been treated with antibiotics for sinusitis (10) Patients in whom evaluation of wheezing is difficult because of such complications; severe allergic rhinitis, congenital respiratory diseases, congenital neurological diseases, congenital heart diseases (11) Patients who suffers from GERD (12) Patients who are hypersensitive to steroids (13) Patients who has been enrolled in another clinical trial (14) Patients who was evaluated to be inappropriate for enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The reccrence rate (person-year) ratio of exacerbations during the study period in the intermittent ICS group to those in the daily ICS group | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) time to event 2) changes in respiratory symptom scores 3) total body use of steroids 4) treatment failure rate 5) changes in blood periostin levels 6) the rate of consultation associated with respiratory symptoms 7) the levels of control of asthmatic symptoms 8) QOL (visual analogue scale) | — |
Countries
Japan
Contacts
Public ContactToshio Katsunuma
Jikei University Daisan Hospital Department of Pediatrics
Outcome results
None listed