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NCT00659048 · ClinicalTrials.gov registry record · Phase 3

Investigation of Potential Additive Inhibitory Effects on HPA-Axis of Ciclesonide Nasal Spray When Administered Concomitantly With Orally Inhaled Beclomethasone Dipropionate (HFA-BDP) in Patients With Perennial Allergic Rhinitis (PAR) (BY9010/M1-408)

A Phase 3 study, sponsored by AstraZeneca.

Completed
Registry status
Phase 3
Development phase
106
Enrollment target

NCT00659048: Completed Phase 3 study, sponsored by AstraZeneca.

NCT00659048 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 106 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00659048, a Phase 3 study, has completed, sponsored by AstraZeneca.

COMPLETED
Registry status
Phase 3
Development phase
106 participants
Enrollment target

Study Summary

The primary objective of this study is to demonstrate that there are no clinically relevant additive inhibitory effects on the HPA-axis when ciclesonide nasal spray is concomitantly administered with orally inhaled HFA-BDP. The secondary objectives are to evaluate safety and tolerability of the combined dosing regimen of orally inhaled HFA-BDP and ciclesonide nasal spray.

Interventions

  • DRUG Placebo
  • DRUG Ciclesonide

Trial Details

FieldValue
Enrollment Target 106 participants
Start Date 2004-12
Est. Completion 2005-12
Phase Phase 3
AstraZeneca

1,285 total trials

What the finished NCT00659048 record still lists

NCT00659048 is an interventional study that assigns participants to a tested intervention. The registered 106 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT00659048 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00659048 about?

NCT00659048 is a clinical study titled "Investigation of Potential Additive Inhibitory Effects on HPA-Axis of Ciclesonide Nasal Spray When Administered Concomitantly With Orally Inhaled Beclomethasone Dipropionate (HFA-BDP) in Patients With Perennial Allergic Rhinitis (PAR) (BY9010/M1-408)". The primary objective of this study is to demonstrate that there are no clinically relevant additive inhibitory effects on the HPA-axis when ciclesonide nasal spray is concomitantly administered with orally inhaled HFA-BDP. The secondary objectives are to evaluate safety and tolerability of the comb...

What is the current status of trial NCT00659048?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 106 participants. The study started on 2004-12. Estimated completion is 2005-12.

What interventions are being tested in trial NCT00659048?

The interventions under investigation include: Placebo (DRUG), Ciclesonide (DRUG).

Who is sponsoring clinical trial NCT00659048?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00659048's enrollment target sits among peer trials

106 1666th of 2000 higher than 331 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT00659048, the US trial registry maintained by the National Library of Medicine. NCT00659048 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.