UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025064 |
|---|---|
| Receipt number | R000028836 |
| Scientific Title | Safety of Inhaled Corticosteroid Use in Children with Asthma - a feasibility study. |
| Date of disclosure of the study information | 2016/11/30 |
| Last modified on | 2019/06/03 22:40:59 |
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Basic information
Public title
Safety of Inhaled Corticosteroid Use in Children with Asthma - a feasibility study.
Acronym
Safety of Inhaled Corticosteroids in Children with Asthma
Scientific Title
Safety of Inhaled Corticosteroid Use in Children with Asthma - a feasibility study.
Scientific Title:Acronym
Safety of Inhaled Corticosteroids in Children with Asthma
Region
| North America |
Condition
Condition
Childhood asthma
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess whether plasma drug concentrations in children aged 6-18 following the inhalation of their prescribed dose of an inhaled corticosteroid (ICS) with metered-dose inhaler (MDI) with holding chamber (for beclomethasone dipropionate, ciclesonide, or fluticasone), or with dry-powder inhaler (DPI) in the case of budesonide +/- formoterol, and salivary cortisol levels can be adequately measured in our lab.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Serum concentration of beclomethasone 17-monopropionate, budesonide, fluticasone propionate, or des-ciclesonid at the respective expected Tmax following inhalation of the patient's regular prescribed dose.
Key secondary outcomes
1) Percentage of drug serum concentration detected at Tmax after inhalation, of total inhaled dose.
2) Fold-increase from baseline to Tmax after drug inhalation.
3) Differences between the investigated ICS products with regard to their baseline and peak serum concentrations.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 6 | years-old | < |
Age-upper limit
| 18 | years-old | > |
Gender
Male and Female
Key inclusion criteria
- Children and adolescents 6 to 18 years of age with physician-diagnosed stable, persistent asthma on a daily dose of one of the 4 studied ICS, administered via MDI with holding chamber (AeroChamber with mouth piece), or in case of budesonide +/- formoterol via DPI.
- No change in their prescribed ICS treatment dose for at least 1 month prior to enrollment.
- Ability to correctly take the medication as assessed by a member of the research team.
- Compliant with medication (assessed by history given by child and caretaker)
Key exclusion criteria
- Individuals who do not speak and understand English
- ICS used with other than the defined devices (see inclusion criteria)
- Inability to correctly take the medication with the required device
- Poor adherence to studied ICS (more than 2 missed doses per week)
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Dirk |
| Middle name | |
| Last name | Bock |
Organization
Children's Hospital, London Health Sciences Centre, Western University
Division name
Paediatrics
Zip code
N6A5W9
Address
800 Commissioners Road East, London, ON N6A 5W9, Canada
TEL
5196858824
dirk.bock@lhsc.on.ca
Public contact
Name of contact person
| 1st name | Melinda |
| Middle name | |
| Last name | Pihokker |
Organization
Children's Hospital, London Health Sciences Centre
Division name
Paediatrics
Zip code
N6A5W9
Address
800 Commissioners Road East, London, ON N6A 5W9, Canada
TEL
5196858500
Homepage URL
melinda.pihokker@lhsc.on.ca
Sponsor or person
Institute
Lawson Health Research Institute
Institute
Department
Personal name
Funding Source
Organization
Internal (Department of Paediatrics, Children's Health Research Institute).
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Office of Human Research Ethics, Western University
Address
1393 Western Road, London Ontario, Canada
Tel
+1-519-661-3036
ethics@uwo.ca
Secondary IDs
Secondary IDs
YES
Study ID_1
102492
Org. issuing International ID_1
Office of Human Research Ethics, Western University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
1) Children's Hospital, London Health Sciences Centre, Western University, London, Ontario, Canada
2) Lawson Health Research Institute, London Health Sciences Centre, London, Ontario, Canada
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 11 | Month | 30 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 05 | Month | 16 | Day |
Date of IRB
| 2012 | Year | 05 | Month | 16 | Day |
Anticipated trial start date
| 2013 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Comment on reason for study termination:
Mainly due to recruitment issues, also due to funding and manpower challenges, decision was made to terminate the study.
Management information
Registered date
| 2016 | Year | 11 | Month | 30 | Day |
Last modified on
| 2019 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028836
