Safety of Ciclesonide Nasal Spray Administered With Inhaled Fluticasone Dipropionate/Salmeterol in Adults With Perennial Allergic Rhinitis (BY9010/M1-409)

Back to results

Primary Purpose

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Ciclesonide

About this trial

This is an interventional treatment trial for Perennial Allergic Rhinitis focused on measuring Allergy, Perennial Allergic Rhinitis, Allergic Rhinitis, Hay Fever

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Main Inclusion Criteria: 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 Main Exclusion Criteria: 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

Sites / Locations

Altana Pharma/Nycomed

Outcomes

Primary Outcome Measures

safety.

Secondary Outcome Measures

safety and tolerability.

Full Information

NCT ID

NCT00163488

First Posted

September 12, 2005

Last Updated

December 2, 2016

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT00163488

Brief Title

Safety of Ciclesonide Nasal Spray Administered With Inhaled Fluticasone Dipropionate/Salmeterol in Adults With Perennial Allergic Rhinitis (BY9010/M1-409)

Official Title

Investigation of Potential Additive Inhibitory Effects on HPA-Axis of Ciclesonide Nasal Spray When Administered Concomitantly With Orally Inhaled Fluticasone Propionate/Salmeterol (FP/SAL) in Patients (18-60 Years) With Perennial Allergic Rhinitis (PAR)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

January 2005 (undefined)

Primary Completion Date

August 2005 (Actual)

Study Completion Date

August 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Perennial Allergic Rhinitis, Allergic Rhinitis, Hay Fever

Keywords

Allergy, Perennial Allergic Rhinitis, Allergic Rhinitis, Hay Fever

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

106 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Ciclesonide

Primary Outcome Measure Information:

Title

safety.

Secondary Outcome Measure Information:

Title

safety and tolerability.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Main Inclusion Criteria: 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 Main Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

AstraZeneca AstraZeneca

Organizational Affiliation

AstraZeneca

Official's Role

Study Director

Facility Information:

Facility Name

Altana Pharma/Nycomed

City

Long Beach

State/Province

California

ZIP/Postal Code

90806

Country

United States

12. IPD Sharing Statement

Links:

URL

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4537&filename=BY9010-M1-409-RDS-2005-12-12.pdf

Description

BY9010-M1-409-RDS-2005-12-12.pdf

Perennial Allergic Rhinitis, Allergic Rhinitis, Hay Fever

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial