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NCT00370097 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 1
Development phase
16
Enrollment target

NCT00370097: Completed Phase 1 study, sponsored by GlaxoSmithKline.

NCT00370097 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00370097, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 1
Development phase
16 participants
Enrollment target

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.

Interventions

  • DRUG FLOVENT (fluticasone propionate) HFA
  • DRUG Placebo HFA

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2006-08-30
Est. Completion 2007-04-12
Phase Phase 1
GlaxoSmithKline

1,345 total trials

What the finished NCT00370097 record still lists

NCT00370097 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).

The record links to 0 conditions, and to 2 interventions - of which FLOVENT (fluticasone propionate) HFA is the first listed.

NCT00370097 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00370097 about?

NCT00370097 is a clinical study titled "FLOVENT Hydrofluoroalkane (HFA) In 6-12 Month Old Subjects". 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.

What is the current status of trial NCT00370097?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2006-08-30. Estimated completion is 2007-04-12.

What interventions are being tested in trial NCT00370097?

The interventions under investigation include: FLOVENT (fluticasone propionate) HFA (DRUG), Placebo HFA (DRUG).

Who is sponsoring clinical trial NCT00370097?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00370097's enrollment target sits among peer trials

16 1786th of 2000 higher than 203 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00370097, the US trial registry maintained by the National Library of Medicine. NCT00370097 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.