Ignite Creation Date:
2024-05-05 @ 7:14 PM
Last Modification Date:
2024-10-26 @ 9:46 AM
Study NCT ID:
NCT00635882
Status:
COMPLETED
Last Update Posted:
2024-05-14
First Post:
2008-01-21
Brief Title:
Asthma Study Comparing Anti-Inflammatory Effects of 3 Doses of Mometasone FuroateFormoterol Fumarate and Medium Dose Mometasone Furoate Study P05122 AM1COMPLETED
Sponsor:
Organon and Co
Organization:
Organon and Co
Study Overview
Official Title:
A 2-Week Double-Blind Placebo-Controlled Parallel Group Study Comparing the Anti-Inflammatory Effects of Low Medium and High Dose Mometasone FuroateFormoterol Fumarate MDI Formulation and Medium Dose Mometasone Furoate DPI and MDI Formulations in Adults and Adolescents With Persistent Allergic Asthma
Status:
COMPLETED
Status Verified Date:
2022-02
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:
None
Brief Summary:
This is a 2-week double-blind placebo-controlled parallel group study comparing the anti-inflammatory effects of low medium and high dose mometasone furoateformoterol fumarate MFF metered dose inhaler MDI formulation and medium dose mometasone furoate MF dry powder inhaler DPI and MDI formulations in adults and adolescents with persistent allergic asthma
Detailed Description:
This is a 2-week double-blind placebo-controlled parallel group study comparing the anti-inflammatory effects of low medium and high dose mometasone furoateformoterol fumarate MDI formulation and medium dose mometasone furoate MF DPI and MDI formulations in adults and adolescents with persistent allergic asthma An open-label run in period is to be followed by a double-blind treatment period
A total of 90 subjects 15 per treatment will be enrolled to ensure 12 subjects per treatment at the Day 14 evaluation accounting for a 20 drop-out rate A sample size of 12 subjects per treatment is required to detect a treatment difference of 28 in percent change of eNO at Day 14 assuming a pooled standard deviation of 20 with a power of 90 These estimates are based on examination of eNO levels in asthmatic vs healthy subjects in an article written by SA Kharitonov et al 2003
Subjects will be randomized to one of six treatment groups MFF MDI 10010 mcg BID MFF MDI 20010 mcg BID MFF MDI 40010 mcg BID MF DPI 200 mcg BID MF MDI 200 mcg BID or Placebo MDI BID according to an Schering-Plough Research Institute SPRI computer-generated randomization schedule Randomization will be performed in appropriately sized blocks using random numbers generated by statistical analysis software SAS
A total of 90 subjects 15 per treatment will be enrolled to ensure 12 subjects per treatment at the Day 14 evaluation accounting for a 20 drop-out rate A sample size of 12 subjects per treatment is required to detect a treatment difference of 28 in percent change of eNO at Day 14 assuming a pooled standard deviation of 20 with a power of 90 These estimates are based on examination of eNO levels in asthmatic vs healthy subjects in an article written by SA Kharitonov et al 2003
Subjects will be randomized to one of six treatment groups MFF MDI 10010 mcg BID MFF MDI 20010 mcg BID MFF MDI 40010 mcg BID MF DPI 200 mcg BID MF MDI 200 mcg BID or Placebo MDI BID according to an Schering-Plough Research Institute SPRI computer-generated randomization schedule Randomization will be performed in appropriately sized blocks using random numbers generated by statistical analysis software SAS
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