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Efficacy of Ciclesonide Versus Fluticasone Propionate in Patients With Mild to Moderate Asthma (12 to 75 y) (BY9010/M1-142)

Primary Purpose

Asthma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ciclesonide
Sponsored by
AstraZeneca
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, Ciclesonide, Fluticasone propionate

Eligibility Criteria

12 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Main Inclusion Criteria: Outpatients Written informed consent History of bronchial asthma for at least 6 months Good health with the exception of asthma Treated with inhaled steroids with a maximum daily constant dosage of 250 mcg fluticasone propionate or equivalent FEV1 80 - 105% of predicted Main Exclusion Criteria: Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids COPD (i.e. chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in lung function Current smoking with more than 10 pack-years Previous smoking with more than 10 pack-years Use of systemic steroids 4 weeks (injectable depot steroids 6 weeks) before entry into the baseline period, or more than 2 times Pregnancy Intention to become pregnant during the course of the study Breast feeding Lack of safe contraception

Sites / Locations

  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed
  • Altana Pharma/Nycomed

Outcomes

Primary Outcome Measures

FEV1
time to the first asthma exacerbation.

Secondary Outcome Measures

FVC
asthma symptom score
use of rescue medication
AQLQ(S) and EQ-5D
percentage of days on which patients perceived asthma control
percentage of nocturnal awakening-free days
percentage of rescue medication-free days
percentage of asthma symptom-free days
physical examination
vital signs
standard laboratory work-up
adverse events
number of patients with local oropharyngeal adverse events.

Full Information

First Posted
September 12, 2005
Last Updated
December 7, 2016
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00163423
Brief Title
Efficacy of Ciclesonide Versus Fluticasone Propionate in Patients With Mild to Moderate Asthma (12 to 75 y) (BY9010/M1-142)
Official Title
Comparison of Ciclesonide (80 mcg Once Daily in the Evening) and Fluticasone Propionate (100 mcg Twice Daily) in Patients With Mild to Moderate Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
January 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

Brief Summary
The aim of the study is to compare the efficacy of ciclesonide versus fluticasone propionate on lung function, time to first asthma exacerbation, asthma symptoms, use of rescue medication, and quality of life in patients with mild to moderate asthma. Ciclesonide will be inhaled at one dose level once daily; fluticasone propionate will be inhaled at one dose level twice daily. The study duration consists of a baseline period (2 to 4 weeks) and a treatment period (24 weeks). The study will provide further data on safety and tolerability of ciclesonide.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Ciclesonide, Fluticasone propionate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
480 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Ciclesonide
Primary Outcome Measure Information:
Title
FEV1
Title
time to the first asthma exacerbation.
Secondary Outcome Measure Information:
Title
FVC
Title
asthma symptom score
Title
use of rescue medication
Title
AQLQ(S) and EQ-5D
Title
percentage of days on which patients perceived asthma control
Title
percentage of nocturnal awakening-free days
Title
percentage of rescue medication-free days
Title
percentage of asthma symptom-free days
Title
physical examination
Title
vital signs
Title
standard laboratory work-up
Title
adverse events
Title
number of patients with local oropharyngeal adverse events.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria: Outpatients Written informed consent History of bronchial asthma for at least 6 months Good health with the exception of asthma Treated with inhaled steroids with a maximum daily constant dosage of 250 mcg fluticasone propionate or equivalent FEV1 80 - 105% of predicted Main Exclusion Criteria: Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids COPD (i.e. chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in lung function Current smoking with more than 10 pack-years Previous smoking with more than 10 pack-years Use of systemic steroids 4 weeks (injectable depot steroids 6 weeks) before entry into the baseline period, or more than 2 times Pregnancy Intention to become pregnant during the course of the study Breast feeding Lack of safe contraception
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
Gmünd
ZIP/Postal Code
3950
Country
Austria
Facility Name
Altana Pharma/Nycomed
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
Altana Pharma/Nycomed
City
Linz
ZIP/Postal Code
4040
Country
Austria
Facility Name
Altana Pharma/Nycomed
City
Neusiedl/See
ZIP/Postal Code
7100
Country
Austria
Facility Name
Altana Pharma/Nycomed
City
Perg
ZIP/Postal Code
4320
Country
Austria
Facility Name
Altana Pharma/Nycomed
City
Steyr
ZIP/Postal Code
4400
Country
Austria
Facility Name
Altana Pharma/Nycomed
City
Wiener Neustadt
ZIP/Postal Code
2700
Country
Austria
Facility Name
Altana Pharma/Nycomed
City
Brandon
ZIP/Postal Code
R7A 5E7
Country
Canada
Facility Name
Altana Pharma/Nycomed
City
Hamilton
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
Altana Pharma/Nycomed
City
London
ZIP/Postal Code
N5W 6A2
Country
Canada
Facility Name
Altana Pharma/Nycomed
City
London
ZIP/Postal Code
N6C 4Y7
Country
Canada
Facility Name
Altana Pharma/Nycomed
City
Mississauga
ZIP/Postal Code
L5B 1N1
Country
Canada
Facility Name
Altana Pharma/Nycomed
City
Montreal, Quebec
ZIP/Postal Code
H1V 1X5
Country
Canada
Facility Name
Altana Pharma/Nycomed
City
Montreal
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
Altana Pharma/Nycomed
City
Montreal
ZIP/Postal Code
H4J1C5
Country
Canada
Facility Name
Altana Pharma/Nycomed
City
Ottawa
ZIP/Postal Code
K1Y 4G2
Country
Canada
Facility Name
Altana Pharma/Nycomed
City
Quebec City
ZIP/Postal Code
G8T 7A1
Country
Canada
Facility Name
Altana Pharma/Nycomed
City
Sainte-Foy, Quebec
ZIP/Postal Code
G1V4G5
Country
Canada
Facility Name
Altana Pharma/Nycomed
City
Sarnia
ZIP/Postal Code
N7T 4X3
Country
Canada
Facility Name
Altana Pharma/Nycomed
City
Ste-Foy PQ
ZIP/Postal Code
G1V 4M6
Country
Canada
Facility Name
Altana Pharma/Nycomed
City
Toronto
ZIP/Postal Code
M4P1P2
Country
Canada
Facility Name
Altana Pharma/Nycomed
City
Woodstock
ZIP/Postal Code
N4S 4G3
Country
Canada
Facility Name
Altana Pharma/Nycomed
City
Geesthacht
ZIP/Postal Code
21502
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Hannover
ZIP/Postal Code
30167
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Heidelberg
ZIP/Postal Code
69117
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Koblenz
ZIP/Postal Code
56068
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Marburg
ZIP/Postal Code
35037
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Sinsheim
ZIP/Postal Code
74889
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Witten
ZIP/Postal Code
58452
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Bielsko-Biala
ZIP/Postal Code
43316
Country
Poland
Facility Name
Altana Pharma/Nycomed
City
Gdansk
ZIP/Postal Code
80-847
Country
Poland
Facility Name
Altana Pharma/Nycomed
City
Lodz
ZIP/Postal Code
90-141
Country
Poland
Facility Name
Altana Pharma/Nycomed
City
Lubin
ZIP/Postal Code
59300
Country
Poland
Facility Name
Altana Pharma/Nycomed
City
Lublin
ZIP/Postal Code
20-718
Country
Poland
Facility Name
Altana Pharma/Nycomed
City
Lublin
ZIP/Postal Code
20601
Country
Poland
Facility Name
Altana Pharma/Nycomed
City
Walbrzych
ZIP/Postal Code
58300
Country
Poland
Facility Name
Altana Pharma/Nycomed
City
Zgierz
ZIP/Postal Code
95100
Country
Poland
Facility Name
Altana Pharma/Nycomed
City
Arcadia, Pretoria
ZIP/Postal Code
132
Country
South Africa
Facility Name
Altana Pharma/Nycomed
City
Bellville, Cape Town
ZIP/Postal Code
7530
Country
South Africa
Facility Name
Altana Pharma/Nycomed
City
Cape Town, Tygerberg
ZIP/Postal Code
7505
Country
South Africa
Facility Name
Altana Pharma/Nycomed
City
Cape Town
ZIP/Postal Code
7764
Country
South Africa
Facility Name
Altana Pharma/Nycomed
City
Durbanville / Cape Town
ZIP/Postal Code
7550
Country
South Africa
Facility Name
Altana Pharma/Nycomed
City
Gatesville, Cape Town
ZIP/Postal Code
7764
Country
South Africa
Facility Name
Altana Pharma/Nycomed
City
Lyttleton
ZIP/Postal Code
140
Country
South Africa
Facility Name
Altana Pharma/Nycomed
City
Mowbray, Cape Town
ZIP/Postal Code
7925
Country
South Africa
Facility Name
Altana Pharma/Nycomed
City
Observatory Cape
ZIP/Postal Code
7925
Country
South Africa
Facility Name
Altana Pharma/Nycomed
City
Pretoria
ZIP/Postal Code
181
Country
South Africa
Facility Name
Altana Pharma/Nycomed
City
Pretoria
ZIP/Postal Code
2
Country
South Africa
Facility Name
Altana Pharma/Nycomed
City
Westville
ZIP/Postal Code
3630
Country
South Africa
Facility Name
Altana Pharma/Nycomed
City
Wynberg
ZIP/Postal Code
7945
Country
South Africa

12. IPD Sharing Statement

Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4523&filename=BY9010_M1-142%20Synopsis.pdf
Description
BY9010_M1-142 Synopsis.pdf

Learn more about this trial

Efficacy of Ciclesonide Versus Fluticasone Propionate in Patients With Mild to Moderate Asthma (12 to 75 y) (BY9010/M1-142)

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