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Safety of Inhaled Corticosteroid Use in Children with Asthma - a feasibility study.

Safety of Inhaled Corticosteroid Use in Children with Asthma - a feasibility study. - Safety of Inhaled Corticosteroids in Children with Asthma

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000025064
Enrollment
20
Registered
2016-11-30
Start date
2013-03-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood asthma

Interventions

None listed

Sponsors

Lawson Health Research Institute
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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)

Exclusion criteria

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)

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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.

Countries

North America

Contacts

Public ContactMelinda Pihokker

Children's Hospital, London Health Sciences Centre Paediatrics

melinda.pihokker@lhsc.on.ca5196858500

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026