UMIN-CTR Clinical Trial
| 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 |
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Basic information
Public title
Daily versus intermittent inhaled fluticasone in toddlers with recurrent wheezing
Acronym
DIFTO study
Scientific Title
Daily versus intermittent inhaled fluticasone in toddlers with recurrent wheezing
Scientific Title:Acronym
DIFTO study
Region
| Japan |
Condition
Condition
Infants and toddlers with recurrent wheezing (infantile asthma)
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
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.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The reccrence rate (person-year) ratio of exacerbations during the study period in the intermittent ICS group to those in the daily ICS group
Key secondary outcomes
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)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
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).
Interventions/Control_2
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.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 12 | months-old | <= |
Age-upper limit
| 59 | months-old | >= |
Gender
Male and Female
Key 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).
Key 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
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Toshio |
| Middle name | |
| Last name | Katsunuma |
Organization
Jikei University Daisan Hospital
Division name
Department of Pediatrics
Zip code
2018601
Address
4-11-1, Izumi-Honcho, Komae City, Tokyo
TEL
03-3480-1151
tkatsunuma@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Toshio |
| Middle name | |
| Last name | Katsunuma |
Organization
Jikei University Daisan Hospital
Division name
Department of Pediatrics
Zip code
2018601
Address
4-11-1, Izumi-Honcho, Komae City, Tokyo
TEL
03-3480-1151
Homepage URL
tkatsunuma@jikei.ac.jp
Sponsor or person
Institute
Jikei University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development,
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Jikei University
Address
3-25-8, Nishishinbashi, Minato-ku, Tokyo
Tel
03-3433-1111
rinri@jikei.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2015 | Year | 03 | Month | 05 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 09 | Day |
Anticipated trial start date
| 2015 | Year | 09 | Month | 24 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 03 | Month | 08 | Day |
Last modified on
| 2023 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019425
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| Registered date | File name |
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