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Study to show safety of fluticasone propionate in pre-asthmatic patients aged 6 months to <12 months.

A repeat-dose, open-label, 2-session study to assess the systemic exposure to, and pharmacodynamics of, fluticasone propionate HFA inhalation aerosol 88 mcg administered twice-daily for 28 days delivered via an MDI and valved holding chamber with infant face mask to subjects ages 6 months to <12 months who have experienced 2 or more wheezing episodes in the preceding 6 months.

Status
Unknown
Phases
Phase 1
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2015-004884-35-Outside-EU/EEA
Enrollment
16
Registered
2016-12-21
Start date
Unknown
Completion date
Unknown
Last updated
2017-01-09

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

Conditions

Asthma MedDRA version: 19.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Product Name: fluticasone propionate Pharmaceutical Form: Inhalation powder INN or Proposed INN: FLUTICASONE PROPIONATE CAS Number: 80474-14-2 Other descriptive name: FLUTICASONE PROPIONATE Concentrat

Sponsors

GlaxoSmithKline Research & Development
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Subjects who have experienced 2 or more wheezing episodes in the previous 6 months. - Subjects may not have taken any corticosteroids in the 4 weeks prior to dosing -Parents/guardians should be able to read and comprehend diary information collected throughout the study -Parents must be able to demonstrate the ability to use the facemask and spacer used to administer study drug Are the trial subjects under 18? yes Number of subjects for this age range: 16 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Subjects who weigh less than 7 kg - Subjects who are taking any drugs that inhibit or induce the cytochrome P450 isoform - Any parents who have a history of psychiatric disease, intellectual deficiency, substance abuse that would compromise the validity of the consent

Design outcomes

Primary

MeasureTime frame
Main Objective: To determine the effect of administration of FP HFA MDI 88 mcg BID on 12 hour serum cortisol in pediatric subjects, ages 6 months to <12 months, who had experienced 2 or more wheezing episodes in the preceding 6 months.;Secondary Objective: Not applicable ;Primary end point(s): Serum cortisol weighted mean(0-12h);Timepoint(s) of evaluation of this end point: Day 14 and Day 28—

Secondary

MeasureTime frame
Secondary end point(s): - Serum cortisol Cmin - FP Cmaxss, AUClast and tmaxss - Adverse events;Timepoint(s) of evaluation of this end point: Day 14 and Day 28—

Countries

United States

Contacts

Public ContactGSK Clinical Support Help Desk

GlaxoSmithKline Research & Development Ltd

GSKClinicalSupportHD@gsk.com+4408007839733

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026