Safety and Tolerability of Ciclesonide Nasal Spray in Pat... | NCT00261287

Studies
Safety and Tolerability of Ciclesonide Nasal Spray in Patients With Perennial Allergic Rhinitis (2-5 Years Old) (BY9010/M1-416)

NCT00261287

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Nov 30, 2016Estimated

Enrollment

102

Phase

Phase 3

Conditions

Hay Fever
Perennial Allergic Rhinitis

Interventions

Ciclesonide

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Official Title

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Clinical Trial Designed to Assess the Safety and Tolerability of Ciclesonide (200 mcg Once Daily), Applied as a Nasal Spray for Twelve Weeks, in the Treatment of Perennial Allergic Rhinitis (PAR) in Pediatric Patients 2-5 Years of Age

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2005

Primary Completion Date

Jun 2006Actual

Completion Date

Jun 2006Actual

First Submitted Date

Dec 2, 2005

First Submission Date that Met QC Criteria

Dec 2, 2005

First Posted Date

Dec 5, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 29, 2016

Last Update Posted Date

Nov 30, 2016Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

102

Name	Type	Description	Arm Group Labels	Other Names
Ciclesonide	Drug

Measure	Description	Time Frame
Safety and tolerability of ciclesonide nasal spray

Eligibility Module

Eligibility Criteria

Main Inclusion Criteria:

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

Main Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

5 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
AstraZeneca AstraZeneca	AstraZeneca	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Altana Pharma/Nycomed		Long Beach	California	90806	United States
Altana Pharma/Nycomed

Label	URL
BY9010-M1-416-RDS-2007-03-22.pdf	View source

Condition Browse Module

MeSH Terms

ID	Term
D006255	Rhinitis, Allergic, Seasonal
D012221	Rhinitis, Allergic, Perennial
D065631	Rhinitis, Allergic

Ancestor Terms

ID	Term
D012220	Rhinitis
D009668	Nose Diseases
D012140	Respiratory Tract Diseases
D012130	Respiratory Hypersensitivity

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C120481	ciclesonide

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided