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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: Completed Phase 4 study of Allergic Rhinitis, sponsored by Covis Pharma S.à.r.l..
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary pharmacokinetics comparisons between treatments will be that of 300 mcg OMNARIS™ \[ciclesonide\] nasal spray and 300 mcg ciclesonide nasal HFA aerosol vs. 320 mcg orally inhaled ciclesonide as a reference. At prespecified timepoints, blood samples were obtained from subjects. It was anticipated that only a limited number of des-ciclesonide concentrations would exceed the lower limit of quantification (LLOQ) of 10 pg/mL for ciclesonide aqueous nasal spray. AUC for the aqueous nasal sp
Conditions Studied
Interventions
- DRUG Ciclesonide
Study Locations (1)
Texas
- ALTANA Pharma - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2007-04 |
| Est. Completion | 2008-04 |
| Phase | Phase 4 |
What the finished NCT00458835 record still lists
NCT00458835 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 104-participant average among 23 other Allergic Rhinitis trials with a reported enrollment target (71% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT00458835's enrollment target sits among peer trials
30 17th of 23 higher than 7 of 23 other Allergic Rhinitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Allergic Rhinitis 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.
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