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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028836


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name