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NCT00458835 · ClinicalTrials.gov registry record · Phase 4

Comparison Between Systemic Exposure to Ciclesonide Nasal Spray, Ciclesonide HFA Nasal Aerosol and Orally Inhaled Ciclesonide (BY9010/M1-422)

A Phase 4 study of Allergic Rhinitis, sponsored by Covis Pharma S.à.r.l..

Completed
Registry status
Phase 4
Development phase
30
Enrollment target
1
Study location

NCT00458835 is a Phase 4 study of Allergic Rhinitis that has completed, run by Covis Pharma S.à.r.l.. The registered enrollment target is 30 participants, below the 104-participant average among 23 other Allergic Rhinitis trials with a reported enrollment target (71% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00458835, a Phase 4 study of Allergic Rhinitis, has completed, sponsored by Covis Pharma S.à.r.l..

COMPLETED
Registry status
Phase 4
Development phase
30 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to compare the systemic des-ciclesonide exposure of OMNARIS™ (ciclesonide) nasal spray, ciclesonide HFA nasal aerosol, and orally inhaled ciclesonide HFA-metered-dose inhaler (MDI). The administration of the study medication will be as follows: three single doses, separated by a wash-out period. The study will provide further data on the safety and tolerability of ciclesonide.

Conditions Studied

Interventions

  • DRUG Ciclesonide

Study Locations (1)

Texas

  • ALTANA Pharma - Austin

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2007-04
Est. Completion 2008-04
Phase Phase 4

Sponsor

Covis Pharma S.à.r.l.

3 total trials

What the Registry Record Tells You About NCT00458835

The ClinicalTrials.gov registry entry for NCT00458835 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 104-participant average among 23 other Allergic Rhinitis trials with a reported enrollment target (71% lower). The listed sponsor is Covis Pharma S.à.r.l., which has 3 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Allergic Rhinitis appearing as the primary indexed condition, and to 1 intervention - of which Ciclesonide is the first listed.

NCT00458835 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT00458835 about?

NCT00458835 is a clinical study titled "Comparison Between Systemic Exposure to Ciclesonide Nasal Spray, Ciclesonide HFA Nasal Aerosol and Orally Inhaled Ciclesonide (BY9010/M1-422)". The purpose of this study is to compare the systemic des-ciclesonide exposure of OMNARIS™ (ciclesonide) nasal spray, ciclesonide HFA nasal aerosol, and orally inhaled ciclesonide HFA-metered-dose inhaler (MDI). The administration of the study medication will be as follows: three single doses, separa...

What is the current status of trial NCT00458835?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2007-04. Estimated completion is 2008-04.

What conditions does trial NCT00458835 study?

This clinical trial studies the following conditions: Allergic Rhinitis.

What interventions are being tested in trial NCT00458835?

The interventions under investigation include: Ciclesonide (DRUG).

Who is sponsoring clinical trial NCT00458835?

This trial is sponsored by Covis Pharma S.à.r.l., which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00458835 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

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.