Unique ID issued by UMIN | UMIN000016736 |
---|---|
Receipt number | R000019425 |
Scientific Title | Daily versus intermittent inhaled fluticasone in toddlers with recurrent wheezing |
Date of disclosure of the study information | 2015/05/01 |
Last modified on | 2023/03/16 09:04:24 |
Daily versus intermittent inhaled fluticasone in toddlers with recurrent wheezing
DIFTO study
Daily versus intermittent inhaled fluticasone in toddlers with recurrent wheezing
DIFTO study
Japan |
Infants and toddlers with recurrent wheezing (infantile asthma)
Pediatrics |
Others
NO
To treat patients with infantile asthma with intermittent or daily inhaled fluticasone (fluticasone propionate; FP) for 1 year and compare their effects in reducing exacerbations and to evaluate their safety including growth suppression in the treatment of infantile asthma.
Safety,Efficacy
The reccrence rate (person-year) ratio of exacerbations during the study period in the intermittent ICS group to those in the daily ICS group
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)
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
NO
Central registration
2
Treatment
Medicine |
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 receive 100 µg of inhaled FP twice daily (morning and evening).
2. Daily ICS group: 50 µg 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 evening) of inhaled placebo.
12 | months-old | <= |
59 | months-old | >= |
Male and Female
(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).
(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
500
1st name | Toshio |
Middle name | |
Last name | Katsunuma |
Jikei University Daisan Hospital
Department of Pediatrics
2018601
4-11-1, Izumi-Honcho, Komae City, Tokyo
03-3480-1151
tkatsunuma@jikei.ac.jp
1st name | Toshio |
Middle name | |
Last name | Katsunuma |
Jikei University Daisan Hospital
Department of Pediatrics
2018601
4-11-1, Izumi-Honcho, Komae City, Tokyo
03-3480-1151
tkatsunuma@jikei.ac.jp
Jikei University
Japan Agency for Medical Research and Development,
Other
Japan
Jikei University
3-25-8, Nishishinbashi, Minato-ku, Tokyo
03-3433-1111
rinri@jikei.ac.jp
NO
2015 | Year | 05 | Month | 01 | Day |
Unpublished
No longer recruiting
2015 | Year | 03 | Month | 05 | Day |
2020 | Year | 03 | Month | 09 | Day |
2015 | Year | 09 | Month | 24 | Day |
2020 | Year | 05 | Month | 09 | Day |
2015 | Year | 03 | Month | 08 | Day |
2023 | Year | 03 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019425
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