UMIN-CTR Clinical Trial

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
Email	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
Email	melinda.pihokker@lhsc.on.ca

Sponsor
Institute	Lawson Health Research Institute
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028836