Back to resultsEffects of Inhaled Ciclesonide Versus Fluticasone Propionate Versus Placebo on Lower Leg Growth in Prepubertal Children With Mild Persistent Asthma (6 to 12 y) (BY9010/M1-208)
Primary Purpose
Asthma
Status
Completed
Phase
Phase 3
Locations
Denmark
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, HPA-axis, Pediatric, Linear growth rate
Eligibility Criteria
Main Inclusion Criteria: Written informed consent by the patient's parent(s) or legal guardian(s) and by the patient, if capable Prepubertal stage Good health with the exception of asthma History of asthma for at least 6 months Currently using rescue medication only Main Exclusion Criteria: Childbearing potential (beyond menarche) Concurrent diseases or conditions which may subsequently affect growth COPD or relevant lung diseases causing alternating impairment in lung function Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids History of life-threatening asthma Current smoking
Sites / Locations
- Altana Pharma/Nycomed
Outcomes
Primary Outcome Measures
growth velocity of the right lower leg as measured by knemometry.
Secondary Outcome Measures
HPA-axis function
weight and height
lung function from spirometry
asthma symptom score, use of rescue medication from diary
adverse events
vital signs, including blood pressure, pulse rate
physical examination
laboratory investigation.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00163371
Brief Title
Effects of Inhaled Ciclesonide Versus Fluticasone Propionate Versus Placebo on Lower Leg Growth in Prepubertal Children With Mild Persistent Asthma (6 to 12 y) (BY9010/M1-208)
Official Title
Effect of Ciclesonide (320 mcg/Day) vs Fluticasone Propionate (375 mcg/Day) vs. Placebo on Short-term Linear Growth Rate and HPA-axis Function in Prepubertal Children With Mild Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
December 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 effects of ciclesonide inhaled at one dose level twice daily versus fluticasone propionate inhaled at one dose level twice daily versus placebo, on short-term lower leg growth in prepubertal children with mild persistent asthma. The study duration consists of a baseline period (2 weeks), a treatment period (2 weeks for each treatment), and a wash-out period (2 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, HPA-axis, Pediatric, Linear growth rate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
28 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Ciclesonide
Primary Outcome Measure Information:
Title
growth velocity of the right lower leg as measured by knemometry.
Secondary Outcome Measure Information:
Title
HPA-axis function
Title
weight and height
Title
lung function from spirometry
Title
asthma symptom score, use of rescue medication from diary
Title
adverse events
Title
vital signs, including blood pressure, pulse rate
Title
physical examination
Title
laboratory investigation.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria:
Written informed consent by the patient's parent(s) or legal guardian(s) and by the patient, if capable
Prepubertal stage
Good health with the exception of asthma
History of asthma for at least 6 months
Currently using rescue medication only
Main Exclusion Criteria:
Childbearing potential (beyond menarche)
Concurrent diseases or conditions which may subsequently affect growth
COPD or relevant lung diseases causing alternating impairment in lung function
Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
History of life-threatening asthma
Current smoking
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
Kolding
ZIP/Postal Code
6000
Country
Denmark
12. IPD Sharing Statement
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4528&filename=BY9010-MI-208-RDS-2007-04-11.pdf
Description
BY9010-MI-208-RDS-2007-04-11.pdf
Learn more about this trial
Effects of Inhaled Ciclesonide Versus Fluticasone Propionate Versus Placebo on Lower Leg Growth in Prepubertal Children With Mild Persistent Asthma (6 to 12 y) (BY9010/M1-208)
We'll reach out to this number within 24 hrs