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FLOVENT Hydrofluoroalkane (HFA) In 6-12 Month Old Subjects

NCT00370097 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2017-09-11

No results posted yet for this study

Summary

The purpose of this study is to address an Food Drug and Administration (FDA) request to provide safety data in pre-asthmatic patients, ages 6 months to \<12 months, following administration of fluticasone propionate HFA.

Conditions

Interventions

DRUG

FLOVENT (fluticasone propionate) HFA

FLOVENT HFA consists of a white to off-white suspension of FP (micronized) in a liquefied hydrofluoroalkane propellant, 1,1,1,2-tetrafluoroethane. Subject will receive FP HFA using an Aerochamber Plus with Infant Mask.

DRUG

Placebo HFA

Subjects will receive FP-matched placebo using an Aerochamber Plus with Infant Mask.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
6 Months
Max Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-30
Primary Completion
2007-04-12
Completion
2007-04-12

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00370097 on ClinicalTrials.gov