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Efficacy of Ciclesonide Inhaled Once Daily Versus Fluticasone Propionate Inhaled Twice Daily in Children With Asthma (6 to 11 y) (BY9010/M1-206)

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, Child, Fluticasone propionate, Pediatric

Eligibility Criteria

6 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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
  • 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 absolute values
PD20FEV1 from methacholine challenge.

Secondary Outcome Measures

FEV1 as % of predicted
PEF from spirometry
morning and evening PEF from diary
asthma symptom score from diary
salbutamol MDI use from diary
diurnal PEF fluctuation from diary
dropout rate due to asthma exacerbations and time to the first asthma exacerbation
percentage of asthma symptom-free days, rescue medication-free days, nocturnal awakening free days and days on which patients perceived asthma control
onset of effect assessed by morning PEF, asthma total symptom score and use of rescue medication
interview administered PAQLQ(S), self-administered PACQLQ
physical examination and vital signs
laboratory investigation
AEs
HPA-axis function assessed by free cortisol concentration in 24 hour-urine samples.

Full Information

First Posted
September 12, 2005
Last Updated
December 2, 2016
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00163462
Brief Title
Efficacy of Ciclesonide Inhaled Once Daily Versus Fluticasone Propionate Inhaled Twice Daily in Children With Asthma (6 to 11 y) (BY9010/M1-206)
Official Title
Comparison of Ciclesonide (80 mcg or 160 mcg Once Daily in the Evening) and Fluticasone Propionate (100 mcg Twice Daily in the Morning and Evening) in Pediatric Asthma Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
November 2005 (Actual)
Study Completion Date
November 2005 (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 once daily, using one of the two dose levels; 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
750 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Ciclesonide
Primary Outcome Measure Information:
Title
FEV1 absolute values
Title
PD20FEV1 from methacholine challenge.
Secondary Outcome Measure Information:
Title
FEV1 as % of predicted
Title
PEF from spirometry
Title
morning and evening PEF from diary
Title
asthma symptom score from diary
Title
salbutamol MDI use from diary
Title
diurnal PEF fluctuation from diary
Title
dropout rate due to asthma exacerbations and time to the first asthma exacerbation
Title
percentage of asthma symptom-free days, rescue medication-free days, nocturnal awakening free days and days on which patients perceived asthma control
Title
onset of effect assessed by morning PEF, asthma total symptom score and use of rescue medication
Title
interview administered PAQLQ(S), self-administered PACQLQ
Title
physical examination and vital signs
Title
laboratory investigation
Title
AEs
Title
HPA-axis function assessed by free cortisol concentration in 24 hour-urine samples.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
11 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
Campinas - SP
ZIP/Postal Code
13081970
Country
Brazil
Facility Name
Altana Pharma/Nycomed
City
Curitiba-PR
ZIP/Postal Code
80060900
Country
Brazil
Facility Name
Altana Pharma/Nycomed
City
Florianópolis-SC
ZIP/Postal Code
88040970
Country
Brazil
Facility Name
Altana Pharma/Nycomed
City
Porto Alegre-RS
ZIP/Postal Code
90035003
Country
Brazil
Facility Name
Altana Pharma/Nycomed
City
Porto Alegre-RS
ZIP/Postal Code
90610000
Country
Brazil
Facility Name
Altana Pharma/Nycomed
City
Rio de Janeiro-RJ
ZIP/Postal Code
21941590
Country
Brazil
Facility Name
Altana Pharma/Nycomed
City
Salvador - Bahia
ZIP/Postal Code
41920000
Country
Brazil
Facility Name
Altana Pharma/Nycomed
City
Santo André-SP
ZIP/Postal Code
9060650
Country
Brazil
Facility Name
Altana Pharma/Nycomed
City
Sao Paulo - SP
ZIP/Postal Code
5437000
Country
Brazil
Facility Name
Altana Pharma/Nycomed
City
Sao Paulo-SP
ZIP/Postal Code
4025002
Country
Brazil
Facility Name
Altana Pharma/Nycomed
City
São Paulo-SP
ZIP/Postal Code
1221020
Country
Brazil
Facility Name
Altana Pharma/Nycomed
City
São Paulo-SP
ZIP/Postal Code
5403900
Country
Brazil
Facility Name
Altana Pharma/Nycomed
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Gaißach bei Bad Tölz
ZIP/Postal Code
83674
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Geesthacht
ZIP/Postal Code
21502
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Mainz
ZIP/Postal Code
55101
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
München
ZIP/Postal Code
80337
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
München
ZIP/Postal Code
80939
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Wesel
ZIP/Postal Code
46483
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Wiefelstede
ZIP/Postal Code
26215
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Altana Pharma/Nycomed
City
Budapest
ZIP/Postal Code
1089
Country
Hungary
Facility Name
Altana Pharma/Nycomed
City
Budapest
ZIP/Postal Code
1121
Country
Hungary
Facility Name
Altana Pharma/Nycomed
City
Debrecen
ZIP/Postal Code
4012
Country
Hungary
Facility Name
Altana Pharma/Nycomed
City
Jaszbereny
ZIP/Postal Code
5100
Country
Hungary
Facility Name
Altana Pharma/Nycomed
City
Miskolc
ZIP/Postal Code
3501
Country
Hungary
Facility Name
Altana Pharma/Nycomed
City
Mosdos
ZIP/Postal Code
7257
Country
Hungary
Facility Name
Altana Pharma/Nycomed
City
Pecs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
Altana Pharma/Nycomed
City
Törökbalint
ZIP/Postal Code
2045
Country
Hungary
Facility Name
Altana Pharma/Nycomed
City
Inowroclaw
ZIP/Postal Code
88-100
Country
Poland
Facility Name
Altana Pharma/Nycomed
City
Lodz
ZIP/Postal Code
90-141
Country
Poland
Facility Name
Altana Pharma/Nycomed
City
Lublin
ZIP/Postal Code
20-093
Country
Poland
Facility Name
Altana Pharma/Nycomed
City
Poznan
ZIP/Postal Code
60-214
Country
Poland
Facility Name
Altana Pharma/Nycomed
City
Rzeszow
ZIP/Postal Code
35-301
Country
Poland
Facility Name
Altana Pharma/Nycomed
City
Warszawa
ZIP/Postal Code
01-211
Country
Poland
Facility Name
Altana Pharma/Nycomed
City
Warszawa
ZIP/Postal Code
03-924
Country
Poland
Facility Name
Altana Pharma/Nycomed
City
Zawadzkie
ZIP/Postal Code
46-059
Country
Poland
Facility Name
Altana Pharma/Nycomed
City
Amadora
ZIP/Postal Code
2720276
Country
Portugal
Facility Name
Altana Pharma/Nycomed
City
Faro
ZIP/Postal Code
8000-386
Country
Portugal
Facility Name
Altana Pharma/Nycomed
City
Guimaraes
ZIP/Postal Code
4800055
Country
Portugal
Facility Name
Altana Pharma/Nycomed
City
Lisboa
ZIP/Postal Code
1269-098
Country
Portugal
Facility Name
Altana Pharma/Nycomed
City
Lisboa
ZIP/Postal Code
1649035
Country
Portugal
Facility Name
Altana Pharma/Nycomed
City
Lisboa
ZIP/Postal Code
1990050
Country
Portugal
Facility Name
Altana Pharma/Nycomed
City
Matosinhos
ZIP/Postal Code
4450024
Country
Portugal
Facility Name
Altana Pharma/Nycomed
City
Oliveira de Azemeis
ZIP/Postal Code
3720000
Country
Portugal
Facility Name
Altana Pharma/Nycomed
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Altana Pharma/Nycomed
City
Porto
ZIP/Postal Code
4200319
Country
Portugal
Facility Name
Altana Pharma/Nycomed
City
Setúbal
ZIP/Postal Code
2910446
Country
Portugal
Facility Name
Altana Pharma/Nycomed
City
Viana do Castelo
ZIP/Postal Code
4901858
Country
Portugal
Facility Name
Altana Pharma/Nycomed
City
Vila Nova de Gaia
ZIP/Postal Code
4400-123
Country
Portugal
Facility Name
Altana Pharma/Nycomed
City
Bellville - Cape Town -
ZIP/Postal Code
7530
Country
South Africa
Facility Name
Altana Pharma/Nycomed
City
Cape Town
ZIP/Postal Code
7937
Country
South Africa
Facility Name
Altana Pharma/Nycomed
City
Morningside, Sandton
ZIP/Postal Code
2196
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
Panorama / RSA-Cape Town
ZIP/Postal Code
7500
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=4526&filename=BY9010-MI-206-RDS-2006-09-01.pdf
Description
BY9010-MI-206-RDS-2006-09-01.pdf

Learn more about this trial

Efficacy of Ciclesonide Inhaled Once Daily Versus Fluticasone Propionate Inhaled Twice Daily in Children With Asthma (6 to 11 y) (BY9010/M1-206)

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