Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00163293
Status:
COMPLETED
Last Update Posted:
2017-04-26
First Post:
2005-09-12
Brief Title:
Efficacy of Ciclesonide Inhaled Once Daily Versus Other Corticosteroids Used for Treatment of Mild Asthma in Children 4 to 11 Years BY9010CA-101
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
Effect of Low Dose Continuous Treatment With Ciclesonide Over One Year on the Time to First Exacerbation in Children With Mild Asthma Versus Intermittent Treatment for Exacerbations
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POPCICLE
Brief Summary:
The aim of this study is to compare the efficacy of ciclesonide with respect to reduction of the number of asthma exacerbations in children with mild persistent asthma Treatment medication will be administered as follows ciclesonide will be inhaled once daily using one of the two dose levels versus placebo together with other corticosteroids used as intermittent treatment The study duration consists of a baseline period 3 to 4 weeks and a treatment period 12 months The study will provide further data on safety and tolerability of ciclesonide
Detailed Description:
The drug being tested in this study is called ciclesonide Ciclesonide is being tested to treat children who have mild asthma
The study enrolled 240 patients Participants were randomly assigned by chance like flipping a coin to one of the three treatment groups-which remained undisclosed to the patient and study doctor during the study unless there was an urgent medical need
Ciclesonide 100 µg
Ciclesonide 200 µg
Placebo dummy inactive inhalation - this is a metered-dose inhaler that looks like the study drug but has no active ingredient
All participants were asked to take two puffs from a metered-dose inhaler once daily in the evening for up to 12 months
This multi-center trial was conducted in Canada Hungary and South Africa The overall time to participate in this study was 12 months preceded by a baseline washout period of 3 to 4 weeks Participants made multiple visits to the clinic including a safety follow-up visit within 30 days of the last treatment
The study enrolled 240 patients Participants were randomly assigned by chance like flipping a coin to one of the three treatment groups-which remained undisclosed to the patient and study doctor during the study unless there was an urgent medical need
Ciclesonide 100 µg
Ciclesonide 200 µg
Placebo dummy inactive inhalation - this is a metered-dose inhaler that looks like the study drug but has no active ingredient
All participants were asked to take two puffs from a metered-dose inhaler once daily in the evening for up to 12 months
This multi-center trial was conducted in Canada Hungary and South Africa The overall time to participate in this study was 12 months preceded by a baseline washout period of 3 to 4 weeks Participants made multiple visits to the clinic including a safety follow-up visit within 30 days of the last treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2007-003736-34 | EUDRACT_NUMBER | None | None |
| U1111-1189-7814 | REGISTRY | WHO | None |