NCT00163488

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of combined ciclesonide nasal spray administered along with a fixed combination of inhaled fluticasone dipropionate/salmeterol.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2005

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

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

January 1, 2005

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
Last Updated

December 5, 2016

Status Verified

October 1, 2016

Enrollment Period

7 months

First QC Date

September 12, 2005

Last Update Submit

December 2, 2016

Conditions

Perennial Allergic RhinitisAllergic RhinitisHay Fever

Keywords

AllergyPerennial Allergic RhinitisAllergic RhinitisHay Fever

Outcome Measures

Primary Outcomes (1)

  • safety.

Secondary Outcomes (1)

  • safety and tolerability.

Interventions

CiclesonideDRUG

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • General good health, other than perennial allergic rhinitis
  • History and diagnosis of perennial allergic rhinitis by skin prick
  • Normal body weight as defined by the study protocol

You may not qualify if:

  • Pregnancy, nursing, or plans to become pregnant or donate gametes (ova or sperm) for in vitro fertilization during the study period or for 30 days following the study period
  • Participation in any investigational drug trial within the 30 days preceding the Screening Visit
  • A known hypersensitivity to any corticosteroid or any of the excipients in the formulations
  • Use of any prohibited concomitant medications as defined by the study protocol
  • Previous participation in an intranasal ciclesonide study
  • Non-vaccinated exposure to or active infection with, chickenpox or measles within the 21 days preceding the Screening Visit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Altana Pharma/Nycomed

Long Beach, California, 90806, United States

Location

Related Links

MeSH Terms

Conditions

Rhinitis, Allergic, PerennialRhinitis, AllergicRhinitis, Allergic, SeasonalHypersensitivity

Interventions

ciclesonide

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateImmune 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

September 12, 2005

First Posted

September 14, 2005

Study Start

January 1, 2005

Primary Completion

August 1, 2005

Study Completion

August 1, 2005

Last Updated

December 5, 2016

Record last verified: 2016-10

Locations

US(1)