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NCT00452348 · ClinicalTrials.gov registry record · Phase 4

A 12-Month Study Comparing Fluticasone Propionate/Salmeterol (ADVAIR) DISKUS Combination Product 250/50mcg Twice Daily To Fluticasone Propionate (FLOVENT) DISKUS 250 mcg Twice Daily In Symptomatic Patients With Asthma

A Phase 4 study, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 4
Development phase
628
Enrollment target

NCT00452348 is a Phase 4 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 628 participants.

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The verdict

NCT00452348, a Phase 4 study, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 4
Development phase
628 participants
Enrollment target

Study Summary

This purpose of this study is to show the superiority and long term safety and efficacy of adding a long acting beta agonist (salmeterol) to constant dose of an inhaled corticosteroid (fluticasone propionate) in symptomatic subjects with asthma. The 12-month assessment of asthma control will provide key information on the efficacy and safety of the combination therapy. The safety measure will be an assessment of adverse events

Interventions

  • DRUG Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID
  • DRUG Fluticasone propionate 250 mcg BID

Trial Details

FieldValue
Enrollment Target 628 participants
Start Date 2007-05
Est. Completion 2009-04
Phase Phase 4

Sponsor

GlaxoSmithKline

1,345 total trials

What the Registry Record Tells You About NCT00452348

The ClinicalTrials.gov registry entry for NCT00452348 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 628 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID is the first listed.

NCT00452348 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00452348 about?

NCT00452348 is a clinical study titled "A 12-Month Study Comparing Fluticasone Propionate/Salmeterol (ADVAIR) DISKUS Combination Product 250/50mcg Twice Daily To Fluticasone Propionate (FLOVENT) DISKUS 250 mcg Twice Daily In Symptomatic Patients With Asthma". This purpose of this study is to show the superiority and long term safety and efficacy of adding a long acting beta agonist (salmeterol) to constant dose of an inhaled corticosteroid (fluticasone propionate) in symptomatic subjects with asthma. The 12-month assessment of asthma control will provide...

What is the current status of trial NCT00452348?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 628 participants. The study started on 2007-05. Estimated completion is 2009-04.

What interventions are being tested in trial NCT00452348?

The interventions under investigation include: Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID (DRUG), Fluticasone propionate 250 mcg BID (DRUG).

Who is sponsoring clinical trial NCT00452348?

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

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.