Back to resultsEfficacy of Ciclesonide Inhaled Once Daily Versus Fluticasone Propionate Inhaled Twice Daily in Children With Asthma (4 to 15 y) (BY9010/M1-205)
Primary Purpose
Asthma
Status
Completed
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
Ciclesonide
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring Asthma, Ciclesonide, Child, Fluticasone propionate, Pediatric
Eligibility Criteria
Main Inclusion Criteria: History of persistent bronchial asthma for at least 6 months FEV1 50-90% of predicted Main Exclusion Criteria: Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids COPD (chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in lung function Respiratory tract infection or asthma exacerbation within the last 30 days prior to entry into the study History of life-threatening asthma Premature birth Current smoking Smoking history with either equal or more than 10 pack-years 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
Outcomes
Primary Outcome Measures
FEV1 absolute values.
Secondary Outcome Measures
FEV1 as % of predicted
PEF from spirometry
diary based morning and evening PEF
diary based symptom score
diary based salbutamol MDI use
diurnal PEF fluctuation
drop-out rate due to asthma exacerbations
time until asthma exacerbation
number of symptom free- and rescue medication free days
number of days with asthma control
physical examination
vital signs
laboratory work-up
adverse events.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00163410
Brief Title
Efficacy of Ciclesonide Inhaled Once Daily Versus Fluticasone Propionate Inhaled Twice Daily in Children With Asthma (4 to 15 y) (BY9010/M1-205)
Official Title
A Comparative Study of Inhaled Ciclesonide 200 mcg/Day vs Fluticasone Propionate 200 mcg/Day in Children With Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
December 2004 (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, symptoms, and use of rescue medication in children with persistent 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 (12 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, Child, Fluticasone propionate, Pediatric
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
500 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Ciclesonide
Primary Outcome Measure Information:
Title
FEV1 absolute values.
Secondary Outcome Measure Information:
Title
FEV1 as % of predicted
Title
PEF from spirometry
Title
diary based morning and evening PEF
Title
diary based symptom score
Title
diary based salbutamol MDI use
Title
diurnal PEF fluctuation
Title
drop-out rate due to asthma exacerbations
Title
time until asthma exacerbation
Title
number of symptom free- and rescue medication free days
Title
number of days with asthma control
Title
physical examination
Title
vital signs
Title
laboratory work-up
Title
adverse events.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria:
History of persistent bronchial asthma for at least 6 months
FEV1 50-90% of predicted
Main Exclusion Criteria:
Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
COPD (chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in lung function
Respiratory tract infection or asthma exacerbation within the last 30 days prior to entry into the study
History of life-threatening asthma
Premature birth
Current smoking
Smoking history with either equal or more than 10 pack-years
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
Ahmedabad
ZIP/Postal Code
380 018
Country
India
Facility Name
Altana Pharma/Nycomed
City
Bangalore
ZIP/Postal Code
560 034
Country
India
Facility Name
Altana Pharma/Nycomed
City
Chandigarh
ZIP/Postal Code
160 012
Country
India
Facility Name
Altana Pharma/Nycomed
City
Coimbatore, Tamilnadu
ZIP/Postal Code
641 044
Country
India
Facility Name
Altana Pharma/Nycomed
City
Coimbatore
ZIP/Postal Code
641 004
Country
India
Facility Name
Altana Pharma/Nycomed
City
Coimbatore
ZIP/Postal Code
641 014
Country
India
Facility Name
Altana Pharma/Nycomed
City
Delhi
ZIP/Postal Code
110 007
Country
India
Facility Name
Altana Pharma/Nycomed
City
Kolkatta
ZIP/Postal Code
700091
Country
India
Facility Name
Altana Pharma/Nycomed
City
Mumbai
ZIP/Postal Code
400 004
Country
India
Facility Name
Altana Pharma/Nycomed
City
Mumbai
ZIP/Postal Code
400 012
Country
India
Facility Name
Altana Pharma/Nycomed
City
Mumbai
ZIP/Postal Code
400 022
Country
India
Facility Name
Altana Pharma/Nycomed
City
Mumbai
ZIP/Postal Code
400 026
Country
India
Facility Name
Altana Pharma/Nycomed
City
Pune
ZIP/Postal Code
411 001
Country
India
Facility Name
Altana Pharma/Nycomed
City
Pune
ZIP/Postal Code
411 030
Country
India
Facility Name
Altana Pharma/Nycomed
City
Pune
ZIP/Postal Code
411 033
Country
India
Facility Name
Altana Pharma/Nycomed
City
Shastri Nagar, Jaipur
ZIP/Postal Code
302 016
Country
India
12. IPD Sharing Statement
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4525&filename=BY9010_M1-205%20Synopsis.AZCT.com%20posting.pdf
Description
BY9010_M1-205 Synopsis
Learn more about this trial
Efficacy of Ciclesonide Inhaled Once Daily Versus Fluticasone Propionate Inhaled Twice Daily in Children With Asthma (4 to 15 y) (BY9010/M1-205)
We'll reach out to this number within 24 hrs