NCT00261287

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of ciclesonide nasal spray for long term use in relieving symptoms in perennial allergic rhinitis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2005

Shorter than P25 for phase_3

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 2, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 5, 2005

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

November 30, 2016

Status Verified

October 1, 2016

Enrollment Period

7 months

First QC Date

December 2, 2005

Last Update Submit

November 29, 2016

Conditions

Hay FeverPerennial Allergic Rhinitis

Keywords

Hay FeverAllergic RhinitisPerennial Allergic RhinitisCiclesonide

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability of ciclesonide nasal spray

Interventions

CiclesonideDRUG

Eligibility Criteria

Age2 Years - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • General good health, other than perennial allergic rhinitis
  • History and diagnosis of perennial allergic rhinitis by skin prick test
  • History of perennial allergic rhinitis for a minimum of 90 days immediately before the screening visit

You may not qualify if:

  • Participation in any investigational drug trial within the 30 days before the screening visit
  • Use of any disallowed concomitant medications within the prescribed withdrawal periods before the screening visit
  • A known hypersensitivity to any corticosteroid

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Altana Pharma/Nycomed

Long Beach, California, 90806, United States

Location

Altana Pharma/Nycomed

Normal, Illinois, 61761, United States

Location

Altana Pharma/Nycomed

San Antonio, Texas, 78229, United States

Location

Related Links

MeSH Terms

Conditions

Rhinitis, Allergic, SeasonalRhinitis, Allergic, PerennialRhinitis, Allergic

Interventions

ciclesonide

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • AstraZeneca AstraZeneca

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2005

First Posted

December 5, 2005

Study Start

November 1, 2005

Primary Completion

June 1, 2006

Study Completion

June 1, 2006

Last Updated

November 30, 2016

Record last verified: 2016-10

Locations

US(3)